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ACP roadmap to raise adult immunization rates
NEW ORLEANS – carried out in seven rural southwestern Georgia counties.
“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.
The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.
The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.
The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.
“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.
She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.
“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.
Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.
“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.
It wasn’t easy at first, Dr. Ferguson recalled.
“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.
Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.
“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.
A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”
Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.
“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”
She reported having no financial conflicts regarding her presentation or the adult immunization initiative.
[email protected]
NEW ORLEANS – carried out in seven rural southwestern Georgia counties.
“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.
The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.
The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.
The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.
“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.
She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.
“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.
Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.
“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.
It wasn’t easy at first, Dr. Ferguson recalled.
“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.
Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.
“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.
A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”
Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.
“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”
She reported having no financial conflicts regarding her presentation or the adult immunization initiative.
[email protected]
NEW ORLEANS – carried out in seven rural southwestern Georgia counties.
“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.
The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.
The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.
The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.
“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.
She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.
“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.
Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.
“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.
It wasn’t easy at first, Dr. Ferguson recalled.
“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.
Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.
“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.
A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”
Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.
“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”
She reported having no financial conflicts regarding her presentation or the adult immunization initiative.
[email protected]
REPORTING FROM ACP INTERNAL MEDICINE
Doctors decry inaction on physician-focused APMs
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).
As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.
The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.
So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.
“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.
The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”
The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.
AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”
The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”
Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.
The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.
The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”
Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”
Worst comedy audience: far right or far left?
Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).
David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.
Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.
Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.
His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.
Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.
“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.
Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.
“It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.
Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.
Click here to listen to the interview.
Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).
David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.
Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.
Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.
His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.
Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.
“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.
Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.
“It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.
Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.
Click here to listen to the interview.
Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).
David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.
Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.
Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.
His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.
Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.
“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.
Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.
“It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.
Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.
Click here to listen to the interview.
AS inflammatory back pain criteria fall short in PsA
Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.
There’s reason to believe that the natural history of patients with psoriatic arthritis (PsA) who have axial disease could differ from those without it, and there are differences in how well criteria that are currently used to identify inflammatory back pain (IBP) in people with ankylosing spondylitis (AS) perform in people with PsA, study first author Kristy S. Yap, MBBS, and her colleagues at the University of Toronto Psoriatic Arthritis Clinic wrote in Annals of the Rheumatic Diseases.
“Axial involvement in PsA is a marker of disease severity, and those with axial disease often have worse outcomes, compared with peripheral arthritis alone,” they wrote.
This is backed up by European League Against Rheumatism recommendations that advise clinicians to consider prescribing tumor necrosis factor inhibitors for people with PsA who have active axial involvement.
“Thus, an important question when evaluating a patient with PsA is to determine if axial PsA is present,” they wrote, noting that it was currently unclear whether the three sets of criteria that exist for defining inflammatory back pain in AS – Calin, Rudwaleit, and Assessment of Spondyloarthritis International Society (ASAS) – were useful for screening for axial involvement in people with PsA.
The researchers therefore set out to determine the agreement between rheumatologist judgment of the presence of IBP as well as the presence of IBP according to the three criteria in 171 patients with PsA (52% male, average age 46.6 years), 96 of whom reported chronic back pain, including 65 with IBP and 31 with nonspecific back pain.
Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.
Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).
When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.
When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.
“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.
The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.
The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.
The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”
“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.
“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.
The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.
SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.
Identifying psoriatic arthritis with axial disease (AxPsA) is important because it changes the treatment selection and also may be associated with a more severe disease course. In a recent paper by Yap et al, the investigators underscore the challenges in identifying the prevalence of axial disease in PsA. Many of our patients with PsA report back pain at some point in their disease course, and as the rheumatologist, we must grapple with whether their symptoms represent inflammatory disease that requires a change in therapy.
In this study, the authors examined the correlation of three definitions of inflammatory back pain (IBP) with both the rheumatologist’s assessment of whether the patient has IBP and with the presence of imaging findings such as x-ray or MRI abnormalities in the sacroiliac joints or lumbar spine. Of the 171 patients studied, 38% were reported to have IBP per the rheumatologist, 18% were thought to have noninflammatory back pain, and 32% had imaging findings consistent with AxSpA. The agreement between the rheumatologist and the inflammatory back pain criteria was reasonable (kappa 0.6-0.7). Rheumatologists and IBP criteria had moderate sensitivity (0.73-0.82) for having x-ray or MRI changes consistent with axial disease but low specificity (0.33-0.46). Surprisingly, HLA markers were not good markers of having axial disease in this population, aside from HLA-B38, which was protective but relatively uncommon.
The bottom line is that using IBP criteria or our general gestalt is still not as good as getting appropriate imaging and further underscores the potential need to screen patients with PsA, particularly those reporting back pain, for axial involvement.
Alexis R. Ogdie, MD, is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the steering committee for the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Identifying psoriatic arthritis with axial disease (AxPsA) is important because it changes the treatment selection and also may be associated with a more severe disease course. In a recent paper by Yap et al, the investigators underscore the challenges in identifying the prevalence of axial disease in PsA. Many of our patients with PsA report back pain at some point in their disease course, and as the rheumatologist, we must grapple with whether their symptoms represent inflammatory disease that requires a change in therapy.
In this study, the authors examined the correlation of three definitions of inflammatory back pain (IBP) with both the rheumatologist’s assessment of whether the patient has IBP and with the presence of imaging findings such as x-ray or MRI abnormalities in the sacroiliac joints or lumbar spine. Of the 171 patients studied, 38% were reported to have IBP per the rheumatologist, 18% were thought to have noninflammatory back pain, and 32% had imaging findings consistent with AxSpA. The agreement between the rheumatologist and the inflammatory back pain criteria was reasonable (kappa 0.6-0.7). Rheumatologists and IBP criteria had moderate sensitivity (0.73-0.82) for having x-ray or MRI changes consistent with axial disease but low specificity (0.33-0.46). Surprisingly, HLA markers were not good markers of having axial disease in this population, aside from HLA-B38, which was protective but relatively uncommon.
The bottom line is that using IBP criteria or our general gestalt is still not as good as getting appropriate imaging and further underscores the potential need to screen patients with PsA, particularly those reporting back pain, for axial involvement.
Alexis R. Ogdie, MD, is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the steering committee for the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Identifying psoriatic arthritis with axial disease (AxPsA) is important because it changes the treatment selection and also may be associated with a more severe disease course. In a recent paper by Yap et al, the investigators underscore the challenges in identifying the prevalence of axial disease in PsA. Many of our patients with PsA report back pain at some point in their disease course, and as the rheumatologist, we must grapple with whether their symptoms represent inflammatory disease that requires a change in therapy.
In this study, the authors examined the correlation of three definitions of inflammatory back pain (IBP) with both the rheumatologist’s assessment of whether the patient has IBP and with the presence of imaging findings such as x-ray or MRI abnormalities in the sacroiliac joints or lumbar spine. Of the 171 patients studied, 38% were reported to have IBP per the rheumatologist, 18% were thought to have noninflammatory back pain, and 32% had imaging findings consistent with AxSpA. The agreement between the rheumatologist and the inflammatory back pain criteria was reasonable (kappa 0.6-0.7). Rheumatologists and IBP criteria had moderate sensitivity (0.73-0.82) for having x-ray or MRI changes consistent with axial disease but low specificity (0.33-0.46). Surprisingly, HLA markers were not good markers of having axial disease in this population, aside from HLA-B38, which was protective but relatively uncommon.
The bottom line is that using IBP criteria or our general gestalt is still not as good as getting appropriate imaging and further underscores the potential need to screen patients with PsA, particularly those reporting back pain, for axial involvement.
Alexis R. Ogdie, MD, is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the steering committee for the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.
There’s reason to believe that the natural history of patients with psoriatic arthritis (PsA) who have axial disease could differ from those without it, and there are differences in how well criteria that are currently used to identify inflammatory back pain (IBP) in people with ankylosing spondylitis (AS) perform in people with PsA, study first author Kristy S. Yap, MBBS, and her colleagues at the University of Toronto Psoriatic Arthritis Clinic wrote in Annals of the Rheumatic Diseases.
“Axial involvement in PsA is a marker of disease severity, and those with axial disease often have worse outcomes, compared with peripheral arthritis alone,” they wrote.
This is backed up by European League Against Rheumatism recommendations that advise clinicians to consider prescribing tumor necrosis factor inhibitors for people with PsA who have active axial involvement.
“Thus, an important question when evaluating a patient with PsA is to determine if axial PsA is present,” they wrote, noting that it was currently unclear whether the three sets of criteria that exist for defining inflammatory back pain in AS – Calin, Rudwaleit, and Assessment of Spondyloarthritis International Society (ASAS) – were useful for screening for axial involvement in people with PsA.
The researchers therefore set out to determine the agreement between rheumatologist judgment of the presence of IBP as well as the presence of IBP according to the three criteria in 171 patients with PsA (52% male, average age 46.6 years), 96 of whom reported chronic back pain, including 65 with IBP and 31 with nonspecific back pain.
Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.
Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).
When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.
When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.
“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.
The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.
The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.
The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”
“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.
“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.
The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.
SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.
Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.
There’s reason to believe that the natural history of patients with psoriatic arthritis (PsA) who have axial disease could differ from those without it, and there are differences in how well criteria that are currently used to identify inflammatory back pain (IBP) in people with ankylosing spondylitis (AS) perform in people with PsA, study first author Kristy S. Yap, MBBS, and her colleagues at the University of Toronto Psoriatic Arthritis Clinic wrote in Annals of the Rheumatic Diseases.
“Axial involvement in PsA is a marker of disease severity, and those with axial disease often have worse outcomes, compared with peripheral arthritis alone,” they wrote.
This is backed up by European League Against Rheumatism recommendations that advise clinicians to consider prescribing tumor necrosis factor inhibitors for people with PsA who have active axial involvement.
“Thus, an important question when evaluating a patient with PsA is to determine if axial PsA is present,” they wrote, noting that it was currently unclear whether the three sets of criteria that exist for defining inflammatory back pain in AS – Calin, Rudwaleit, and Assessment of Spondyloarthritis International Society (ASAS) – were useful for screening for axial involvement in people with PsA.
The researchers therefore set out to determine the agreement between rheumatologist judgment of the presence of IBP as well as the presence of IBP according to the three criteria in 171 patients with PsA (52% male, average age 46.6 years), 96 of whom reported chronic back pain, including 65 with IBP and 31 with nonspecific back pain.
Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.
Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).
When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.
When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.
“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.
The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.
The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.
The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”
“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.
“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.
The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.
SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.
FROM ANNALS OF THE RHEUMATIC DISEASES
Key clinical point:
Major finding: Agreement as measured by kappa coefficient between rheumatologist judgment of inflammatory back pain and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).
Study details: Prospectively collected data from 171 patients attending a PsA clinic
Disclosures: The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.
Source: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.
Janssen seeks approval for split dosing of daratumumab
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.
The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.
The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.
Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.
Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.
Surgical outcomes for UC worse since introduction of biologics
Since the approval of more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.
“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”
The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).
A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.
The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”
Dr. Abelson and coauthors reported having no financial relationships.
SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.
Since the approval of more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.
“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”
The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).
A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.
The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”
Dr. Abelson and coauthors reported having no financial relationships.
SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.
Since the approval of more UC patients are having multiple operations to manage their disease and their surgical outcomes tend to be worse, according to a study published in Annals of Surgery.
“Encouragingly, early randomized controlled trials demonstrated that infliximab may reduce the short-term need for surgery,” wrote Jonathan Abelson, MD, of the department of surgery, Cornell University, New York, and his coauthors. “However, even after the development and approval of several other biologic agents to treat UC, 30%-66% of patients treated with biologic agents still ultimately require surgical intervention.”
The study reviewed records of 7,070 patients with UC in a New York State Department of Health database who had colorectal surgery in two comparative time periods: 3,803 from 1995 to 2005, before biologics were available, and 3,267 from 2006 to 2013, after infliximab was approved. Dr. Abelson and coauthors said this is the first study to look at long-term surgical outcomes in a large group of patients with UC over an extended time period. Previous studies have reported conflicting results of how biologic agents for UC can impact surgical outcomes. The researchers set out to explore two hypotheses: whether staged procedures increased after 2005 and whether UC patients had worse outcomes over the past decade. The study results validated both hypotheses. Up until 2005, the proportion of patients who underwent at least three procedures after the index hospitalization was 9%; after 2006, that proportion was 14% (P less than .01).
A potential explanation for trends in postsurgery death may be higher rates of Clostridium difficile after 2005 (10.6% vs. 5.8%; P less than .01), but that was accounted for in the adjusted analysis and is probably not a major factor, the researchers said. After 2006 patients were slightly older and more likely to be on Medicare and nonwhite; they also were sicker, with 28% having two or more comorbidities vs. 10% before 2006.
The investigators offered another explanation: “It is also possible that the immunosuppressive effect of biologic agents ... predisposes patients to worse postoperative outcomes. In addition, it is possible that patients are referred for surgery too late in their disease course because of prolonged medical therapy.”
Dr. Abelson and coauthors reported having no financial relationships.
SOURCE: Abelson JS et al. Ann Surg. 2018:268;311-7.
FROM ANNALS OF SURGERY
Key clinical point: Rates of multiple surgeries for ulcerative colitis have increased since biologic agents were introduced.
Major finding: Fourteen percent of patients have had multiple operations since 2006 vs. 9% before that.
Study details: A longitudinal analysis of 7,070 patients in the New York State Department of Health of Health Statewide Planning and Research Cooperative System database who had surgery for UC from 1995 to 2013.
Disclosures: Dr. Abelson and coauthors reported having no financial relationships.
Source: Abelson JS et al. Ann Surg. 2018;268:311-7.
COPD opposites: Utah and West Virginia
New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.
The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)
Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.
New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.
The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)
Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.
New estimates of chronic obstructive pulmonary disease (COPD) may have Utah residents breathing a sigh of relief. West Virginians, not so much.
The Beehive State has the lowest prevalence of COPD in the country at 2,710 per 100,000 population, while the Mountain State tops the charts at 11,130 per 100,000, according to estimates from the American Lung Association. (Crude rates were calculated by MDedge News using the ALA’s estimates for total persons with COPD in each state and Census Bureau estimates for population.)
Other states with freer-breathing residents include Minnesota, which was just behind Utah with an estimated rate of 3,000 per 100,000 population, Hawaii (3,182), Colorado (3,334), and California (3,409). West Virginia’s rate, however, seems to be an outlier. The state with the next-highest rate, Kentucky, has a calculated prevalence of 8,890 per 100,000 population, followed by Tennessee at 7,880, Alabama at 7,400, and Arkansas at 7,330, using the ALA’s estimates, which were based on data from the 2016 Behavioral Risk Factor Surveillance System survey.
More deliveries now include opioid use disorder
according to the Centers for Disease Control and Prevention.
The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.
Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.
Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”
“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”
Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.
SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.
according to the Centers for Disease Control and Prevention.
The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.
Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.
Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”
“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”
Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.
SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.
according to the Centers for Disease Control and Prevention.
The national prevalence of opioid use disorder increased by 333% as it went from 1.5 cases per 1,000 delivery hospitalizations in 1999 to 6.5 cases per 1,000 in 2014. At the state level, there were significant increases in all 28 states with data available for at least 3 consecutive years during the study period, Sarah C. Haight, MPH, and her associates at the CDC in Atlanta said in the Morbidity and Mortality Weekly Report.
Average annual rate changes for those states ranged from a low of 0.01 per 1,000 delivery hospitalizations per year in California to 5.37 per year in Vermont, with the national rate change coming in at 0.39 per year. Of the 14 states with data available in 1999, Iowa had the lowest rate at 0.1 per 1,000 deliveries and Maryland had the highest at 8.2. In 2014, when data were available for 26 states and the District of Columbia, the highest rate was Vermont’s 48.6 per 1,000 deliveries and the lowest was 0.7 in Washington, D.C., the investigators reported.
Although “increasing trends might represent actual increases in prevalence or improved screening and diagnosis,” Ms. Haight and her associates added that “these estimates also correlate with state opioid prescribing rates in the general population. West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012.”
“These findings illustrate the devastating impact of the opioid epidemic on families across the U.S., including on the very youngest,” said CDC Director Robert R. Redfield, MD. “Untreated opioid use disorder during pregnancy can lead to heartbreaking results. Each case represents a mother, a child, and a family in need of continued treatment and support.”
Data for the analysis came from the Agency for Healthcare Research and Quality’s National Inpatient Sample and State Inpatient Databases.
SOURCE: Haight SC et al. MMWR. 2018 Aug 10;67[31]:845-9.
FROM MMWR
What do you call a koala who is too sweet for its own good? Diabetic
SAN DIEGO – The 14-pound patient with the deep-pile complexion was lethargic, kept drinking a lot of water, and had a glucose level in the range of 600-700 mg/dL. He was nearly comatose by the time medical staff transferred him to a specialized facility.
The diagnosis: Diabetes. The treatment: Insulin. But multiple daily skin pricks were quite a challenge for Quincy the koala. After all, he requires up to 22 hours of shut-eye each day.
What to do? The veterinary staff at the San Diego Zoo turned to the experts – an endocrinologist and a manufacturer of continuous glucose monitors. Now, Quincy has his own CGM, and a medical team that is tracking his glucose levels in real time on their smartphones.
In fact, Athena Philis-Tsimikas, MD, of the Scripps Whittier Diabetes Institute, pulls out her phone and checks on him at least a couple times a day. She also gets alerts if his blood sugar drops too quickly.
“He is definitely another one of my patients,” she said in an interview. But he’s the only one who lives in trees and enjoys a nice eucalyptus smoothie.
Humans are hardly the only mammals who get diabetes
Veterinarians are quite familiar with diabetes. A wide variety of mammals from pigs and apes to horses and dolphins can develop an equivalent of the human condition. Dogs may be prescribed daily insulin shots, and cats even develop peripheral neuropathy and retinopathy like humans with diabetes.
So it’s not entirely surprising that a team at the Los Angeles Zoo diagnosed Quincy, a 3-year-old Queensland koala, with diabetes.
Quincy’s glucose levels should have been around 80-130 mg/dL, similar to the ideal levels in humans, said San Diego Zoo senior veterinarian Cora Singleton, DVM, in an interview. But tests prompted by his symptoms showed his levels were high, she said, and they stayed that way. According to her, that suggested he wasn’t just having a one-time elevation that animals can experience when they’re stressed.
Unfortunately, there are only a few scattered reports of diabetes in koalas, and “there’s not anything documented about treating a koala over a long term,” Dr. Singleton said. “We’re in uncharted territory here.”
So the Los Angeles Zoo sent Quincy down the California coast for more specialized treatment. The San Diego Zoo’s veterinary staff took in Quincy and treated him with glucose tests and insulin shots, Dr. Singleton said. “But we were looking a way for to get more information with less disturbance to Quincy.”
Someone mentioned the idea of a sensor. “We thought, ‘What a great idea,’” Dr. Singleton said. “It would be a way for us to get a lot of information and find out how his highs and lows are related.”
That’s when the team turned to local endocrinologist Dr. Tsimikas for a helping hand.
The key to koala calming: Eucalyptus smoothies
“They did reach out to us and asked what kind of sensors might be available. We connected them to Dexcom,” a CGM company that’s based in San Diego, Dr. Tsimikas said. “We knew the newest one was coming along and suggested they place that on him as a starting point.”
On June 1, a zoo team attached a Dexcom G6 Continuous Glucose Monitoring System to the koala’s side.
“He’s doing very well. He tolerates the CGM superbly,” Dr. Singleton said. And Quincy doesn’t react when sensors are applied, she said, although it helps that he gets to enjoy a eucalyptus smoothie during the procedure. “Put that in a big syringe, and he’ll volunteer for most anything,” she said.
Obesity can trigger diabetes in mammals other than humans. Could eucalyptus overindulgence explain Quincy’s case of diabetes? Nope.
According to Dr. Tsimikas, the ingredients of the eucalyptus smoothie are just pureed eucalyptus leaves that “go down fast and easy.” These naturally have a nice mix of carbohydrates, fat, and protein to better manage the koala’s sugars and other nutritional needs. If he is dropping his blood sugar values fast, there is another dextrose drink they give him in small amounts, which contains 5-10 g carbohydrates. This is enough to help bring his glucose values back up. It is similar to the treatment recommendations provided to humans with diabetes where they are told to take 15 g of carbohydrates such as honey, hard candies, or juice to prevent a severe hypoglycemic episode.
Dr. Singleton noted that Quincy appears to have the koala equivalent is type 1 diabetes mellitus (T1DM).
Dr. Tsimikas noted “We are not finding the typical antibodies that we find in human T1DM. Quincy is showing low insulin levels, which is why it more closely resembles T1DM. We will be doing further analysis and comparisons with nondiabetic koalas in the future to see if it can be better differentiated.
While he appears to have type 1 diabetes, it’s not clear why he developed it, Dr. Singleton said.
While Quincy is only 3 years old, he’s a full-fledged adult in koala terms. Koalas typically live up to their mid-teens, she said.
This speechless patient still manages to communicate
The San Diego Zoo’s veterinary staff is monitoring Quincy and trying to understand how his glucose levels and daily insulin shots affect him. His tiny size has ruled out use of an insulin pump: Although the insulin pumps have been getting smaller and lighter, they are still too large to attach to our tiny friend. Especially since he would need both the CGM device and the pump, there is not a lot of surface area on his body for attachment of all the devices, according to Dr. Tsimikas.
Since Quincy is so tiny, insulin doses must be minuscule to avoid sending him into hypoglycemia, Dr. Tsimikas said. She said the koala’s medical team is planning to try using a NovoPen Echo injector with a half-unit of insulin.
Dr. Singleton noted that for now, “he’s maintaining his body weight, and he has days when he feels spunky. Sometimes, when he knows it’s breakfast time, and he hears his caretakers coming up the doorway with his breakfast, he’ll be very active on his perch.”
But he has sluggish days, too, when he’ll try to sleep in. Dr. Singleton keeps an eye out for grogginess and signs of weakness and hypoglycemia or hyperglycemia like “a little wobble in his step.”
“The biggest thing I’ve learned from Quincy is the value of his particular nonverbal cues,” she said. “I’m starting to understand when he feels like his sugars are a little high or a little low. I imagine that doctors and parents have the same challenges with little patients, along with figuring out how you communicate that this is supposed to help them.”
Dr. Tsimikas agreed, noting that she sees similarities between Quincy and patients who are hospitalized and can’t easily communicate. Now, “we can track the folks who are on the CGM and intervene earlier than before,” said Dr. Tsimikas, who’s part of a clinical trial team testing CGM devices in two hospitals. “It’s almost like having another vital sign.
“It is only when we have all the data on all the other factors that can influence blood sugar, such as eating patterns, insulin dose and timing, and activity level that we can more accurately adjust the medical interventions.” This requires collaboration between all the groups involved in Quincy’s care. In koalas, the collaboration is with the veterinarian, koala zookeepers, dietitian, and the technology monitoring team. Whereas, for humans, we need parents, care providers, diabetes educators, dietitians, and physicians.
It’s not clear if Quincy will need his CGM for the rest of his life. If he’s stable on a specific insulin dose, Dr. Tsimikas said, he may not need it. But it sounds like eucalyptus smoothies will always be a vital part of his regimen.
In the name of thoroughness, take note that Quincy is not the first diabetic zoo animal whose care involved physicians from Scripps. “We have had several other consultations for animals with diabetes. Nearly 25 years ago, a roller-skating chimpanzee with diabetes was brought to the Scripps Whittier Institute labs for evaluation and treatment recommendations. A few years later, one of our medical directors, Alberto Hayek, MD, advised on the care of Lune, a diabetic baboon at the San Diego Zoo, for insulin management. This time we are making house calls to the zoo to treat Quincy in his home environment. Each animal experience offers opportunities to expand our knowledge about diabetes care and exchange approaches that we might not otherwise be aware of. This has been fun and rewarding. I am looking forward to seeing further outcomes from our interactions with Quincy,” according to Dr. Tsimikas.
Dr. Tsimikas reports that her center conducts research with Dexcom and Novo Nordisk. Dr. Singleton reports no relevant disclosures.
SAN DIEGO – The 14-pound patient with the deep-pile complexion was lethargic, kept drinking a lot of water, and had a glucose level in the range of 600-700 mg/dL. He was nearly comatose by the time medical staff transferred him to a specialized facility.
The diagnosis: Diabetes. The treatment: Insulin. But multiple daily skin pricks were quite a challenge for Quincy the koala. After all, he requires up to 22 hours of shut-eye each day.
What to do? The veterinary staff at the San Diego Zoo turned to the experts – an endocrinologist and a manufacturer of continuous glucose monitors. Now, Quincy has his own CGM, and a medical team that is tracking his glucose levels in real time on their smartphones.
In fact, Athena Philis-Tsimikas, MD, of the Scripps Whittier Diabetes Institute, pulls out her phone and checks on him at least a couple times a day. She also gets alerts if his blood sugar drops too quickly.
“He is definitely another one of my patients,” she said in an interview. But he’s the only one who lives in trees and enjoys a nice eucalyptus smoothie.
Humans are hardly the only mammals who get diabetes
Veterinarians are quite familiar with diabetes. A wide variety of mammals from pigs and apes to horses and dolphins can develop an equivalent of the human condition. Dogs may be prescribed daily insulin shots, and cats even develop peripheral neuropathy and retinopathy like humans with diabetes.
So it’s not entirely surprising that a team at the Los Angeles Zoo diagnosed Quincy, a 3-year-old Queensland koala, with diabetes.
Quincy’s glucose levels should have been around 80-130 mg/dL, similar to the ideal levels in humans, said San Diego Zoo senior veterinarian Cora Singleton, DVM, in an interview. But tests prompted by his symptoms showed his levels were high, she said, and they stayed that way. According to her, that suggested he wasn’t just having a one-time elevation that animals can experience when they’re stressed.
Unfortunately, there are only a few scattered reports of diabetes in koalas, and “there’s not anything documented about treating a koala over a long term,” Dr. Singleton said. “We’re in uncharted territory here.”
So the Los Angeles Zoo sent Quincy down the California coast for more specialized treatment. The San Diego Zoo’s veterinary staff took in Quincy and treated him with glucose tests and insulin shots, Dr. Singleton said. “But we were looking a way for to get more information with less disturbance to Quincy.”
Someone mentioned the idea of a sensor. “We thought, ‘What a great idea,’” Dr. Singleton said. “It would be a way for us to get a lot of information and find out how his highs and lows are related.”
That’s when the team turned to local endocrinologist Dr. Tsimikas for a helping hand.
The key to koala calming: Eucalyptus smoothies
“They did reach out to us and asked what kind of sensors might be available. We connected them to Dexcom,” a CGM company that’s based in San Diego, Dr. Tsimikas said. “We knew the newest one was coming along and suggested they place that on him as a starting point.”
On June 1, a zoo team attached a Dexcom G6 Continuous Glucose Monitoring System to the koala’s side.
“He’s doing very well. He tolerates the CGM superbly,” Dr. Singleton said. And Quincy doesn’t react when sensors are applied, she said, although it helps that he gets to enjoy a eucalyptus smoothie during the procedure. “Put that in a big syringe, and he’ll volunteer for most anything,” she said.
Obesity can trigger diabetes in mammals other than humans. Could eucalyptus overindulgence explain Quincy’s case of diabetes? Nope.
According to Dr. Tsimikas, the ingredients of the eucalyptus smoothie are just pureed eucalyptus leaves that “go down fast and easy.” These naturally have a nice mix of carbohydrates, fat, and protein to better manage the koala’s sugars and other nutritional needs. If he is dropping his blood sugar values fast, there is another dextrose drink they give him in small amounts, which contains 5-10 g carbohydrates. This is enough to help bring his glucose values back up. It is similar to the treatment recommendations provided to humans with diabetes where they are told to take 15 g of carbohydrates such as honey, hard candies, or juice to prevent a severe hypoglycemic episode.
Dr. Singleton noted that Quincy appears to have the koala equivalent is type 1 diabetes mellitus (T1DM).
Dr. Tsimikas noted “We are not finding the typical antibodies that we find in human T1DM. Quincy is showing low insulin levels, which is why it more closely resembles T1DM. We will be doing further analysis and comparisons with nondiabetic koalas in the future to see if it can be better differentiated.
While he appears to have type 1 diabetes, it’s not clear why he developed it, Dr. Singleton said.
While Quincy is only 3 years old, he’s a full-fledged adult in koala terms. Koalas typically live up to their mid-teens, she said.
This speechless patient still manages to communicate
The San Diego Zoo’s veterinary staff is monitoring Quincy and trying to understand how his glucose levels and daily insulin shots affect him. His tiny size has ruled out use of an insulin pump: Although the insulin pumps have been getting smaller and lighter, they are still too large to attach to our tiny friend. Especially since he would need both the CGM device and the pump, there is not a lot of surface area on his body for attachment of all the devices, according to Dr. Tsimikas.
Since Quincy is so tiny, insulin doses must be minuscule to avoid sending him into hypoglycemia, Dr. Tsimikas said. She said the koala’s medical team is planning to try using a NovoPen Echo injector with a half-unit of insulin.
Dr. Singleton noted that for now, “he’s maintaining his body weight, and he has days when he feels spunky. Sometimes, when he knows it’s breakfast time, and he hears his caretakers coming up the doorway with his breakfast, he’ll be very active on his perch.”
But he has sluggish days, too, when he’ll try to sleep in. Dr. Singleton keeps an eye out for grogginess and signs of weakness and hypoglycemia or hyperglycemia like “a little wobble in his step.”
“The biggest thing I’ve learned from Quincy is the value of his particular nonverbal cues,” she said. “I’m starting to understand when he feels like his sugars are a little high or a little low. I imagine that doctors and parents have the same challenges with little patients, along with figuring out how you communicate that this is supposed to help them.”
Dr. Tsimikas agreed, noting that she sees similarities between Quincy and patients who are hospitalized and can’t easily communicate. Now, “we can track the folks who are on the CGM and intervene earlier than before,” said Dr. Tsimikas, who’s part of a clinical trial team testing CGM devices in two hospitals. “It’s almost like having another vital sign.
“It is only when we have all the data on all the other factors that can influence blood sugar, such as eating patterns, insulin dose and timing, and activity level that we can more accurately adjust the medical interventions.” This requires collaboration between all the groups involved in Quincy’s care. In koalas, the collaboration is with the veterinarian, koala zookeepers, dietitian, and the technology monitoring team. Whereas, for humans, we need parents, care providers, diabetes educators, dietitians, and physicians.
It’s not clear if Quincy will need his CGM for the rest of his life. If he’s stable on a specific insulin dose, Dr. Tsimikas said, he may not need it. But it sounds like eucalyptus smoothies will always be a vital part of his regimen.
In the name of thoroughness, take note that Quincy is not the first diabetic zoo animal whose care involved physicians from Scripps. “We have had several other consultations for animals with diabetes. Nearly 25 years ago, a roller-skating chimpanzee with diabetes was brought to the Scripps Whittier Institute labs for evaluation and treatment recommendations. A few years later, one of our medical directors, Alberto Hayek, MD, advised on the care of Lune, a diabetic baboon at the San Diego Zoo, for insulin management. This time we are making house calls to the zoo to treat Quincy in his home environment. Each animal experience offers opportunities to expand our knowledge about diabetes care and exchange approaches that we might not otherwise be aware of. This has been fun and rewarding. I am looking forward to seeing further outcomes from our interactions with Quincy,” according to Dr. Tsimikas.
Dr. Tsimikas reports that her center conducts research with Dexcom and Novo Nordisk. Dr. Singleton reports no relevant disclosures.
SAN DIEGO – The 14-pound patient with the deep-pile complexion was lethargic, kept drinking a lot of water, and had a glucose level in the range of 600-700 mg/dL. He was nearly comatose by the time medical staff transferred him to a specialized facility.
The diagnosis: Diabetes. The treatment: Insulin. But multiple daily skin pricks were quite a challenge for Quincy the koala. After all, he requires up to 22 hours of shut-eye each day.
What to do? The veterinary staff at the San Diego Zoo turned to the experts – an endocrinologist and a manufacturer of continuous glucose monitors. Now, Quincy has his own CGM, and a medical team that is tracking his glucose levels in real time on their smartphones.
In fact, Athena Philis-Tsimikas, MD, of the Scripps Whittier Diabetes Institute, pulls out her phone and checks on him at least a couple times a day. She also gets alerts if his blood sugar drops too quickly.
“He is definitely another one of my patients,” she said in an interview. But he’s the only one who lives in trees and enjoys a nice eucalyptus smoothie.
Humans are hardly the only mammals who get diabetes
Veterinarians are quite familiar with diabetes. A wide variety of mammals from pigs and apes to horses and dolphins can develop an equivalent of the human condition. Dogs may be prescribed daily insulin shots, and cats even develop peripheral neuropathy and retinopathy like humans with diabetes.
So it’s not entirely surprising that a team at the Los Angeles Zoo diagnosed Quincy, a 3-year-old Queensland koala, with diabetes.
Quincy’s glucose levels should have been around 80-130 mg/dL, similar to the ideal levels in humans, said San Diego Zoo senior veterinarian Cora Singleton, DVM, in an interview. But tests prompted by his symptoms showed his levels were high, she said, and they stayed that way. According to her, that suggested he wasn’t just having a one-time elevation that animals can experience when they’re stressed.
Unfortunately, there are only a few scattered reports of diabetes in koalas, and “there’s not anything documented about treating a koala over a long term,” Dr. Singleton said. “We’re in uncharted territory here.”
So the Los Angeles Zoo sent Quincy down the California coast for more specialized treatment. The San Diego Zoo’s veterinary staff took in Quincy and treated him with glucose tests and insulin shots, Dr. Singleton said. “But we were looking a way for to get more information with less disturbance to Quincy.”
Someone mentioned the idea of a sensor. “We thought, ‘What a great idea,’” Dr. Singleton said. “It would be a way for us to get a lot of information and find out how his highs and lows are related.”
That’s when the team turned to local endocrinologist Dr. Tsimikas for a helping hand.
The key to koala calming: Eucalyptus smoothies
“They did reach out to us and asked what kind of sensors might be available. We connected them to Dexcom,” a CGM company that’s based in San Diego, Dr. Tsimikas said. “We knew the newest one was coming along and suggested they place that on him as a starting point.”
On June 1, a zoo team attached a Dexcom G6 Continuous Glucose Monitoring System to the koala’s side.
“He’s doing very well. He tolerates the CGM superbly,” Dr. Singleton said. And Quincy doesn’t react when sensors are applied, she said, although it helps that he gets to enjoy a eucalyptus smoothie during the procedure. “Put that in a big syringe, and he’ll volunteer for most anything,” she said.
Obesity can trigger diabetes in mammals other than humans. Could eucalyptus overindulgence explain Quincy’s case of diabetes? Nope.
According to Dr. Tsimikas, the ingredients of the eucalyptus smoothie are just pureed eucalyptus leaves that “go down fast and easy.” These naturally have a nice mix of carbohydrates, fat, and protein to better manage the koala’s sugars and other nutritional needs. If he is dropping his blood sugar values fast, there is another dextrose drink they give him in small amounts, which contains 5-10 g carbohydrates. This is enough to help bring his glucose values back up. It is similar to the treatment recommendations provided to humans with diabetes where they are told to take 15 g of carbohydrates such as honey, hard candies, or juice to prevent a severe hypoglycemic episode.
Dr. Singleton noted that Quincy appears to have the koala equivalent is type 1 diabetes mellitus (T1DM).
Dr. Tsimikas noted “We are not finding the typical antibodies that we find in human T1DM. Quincy is showing low insulin levels, which is why it more closely resembles T1DM. We will be doing further analysis and comparisons with nondiabetic koalas in the future to see if it can be better differentiated.
While he appears to have type 1 diabetes, it’s not clear why he developed it, Dr. Singleton said.
While Quincy is only 3 years old, he’s a full-fledged adult in koala terms. Koalas typically live up to their mid-teens, she said.
This speechless patient still manages to communicate
The San Diego Zoo’s veterinary staff is monitoring Quincy and trying to understand how his glucose levels and daily insulin shots affect him. His tiny size has ruled out use of an insulin pump: Although the insulin pumps have been getting smaller and lighter, they are still too large to attach to our tiny friend. Especially since he would need both the CGM device and the pump, there is not a lot of surface area on his body for attachment of all the devices, according to Dr. Tsimikas.
Since Quincy is so tiny, insulin doses must be minuscule to avoid sending him into hypoglycemia, Dr. Tsimikas said. She said the koala’s medical team is planning to try using a NovoPen Echo injector with a half-unit of insulin.
Dr. Singleton noted that for now, “he’s maintaining his body weight, and he has days when he feels spunky. Sometimes, when he knows it’s breakfast time, and he hears his caretakers coming up the doorway with his breakfast, he’ll be very active on his perch.”
But he has sluggish days, too, when he’ll try to sleep in. Dr. Singleton keeps an eye out for grogginess and signs of weakness and hypoglycemia or hyperglycemia like “a little wobble in his step.”
“The biggest thing I’ve learned from Quincy is the value of his particular nonverbal cues,” she said. “I’m starting to understand when he feels like his sugars are a little high or a little low. I imagine that doctors and parents have the same challenges with little patients, along with figuring out how you communicate that this is supposed to help them.”
Dr. Tsimikas agreed, noting that she sees similarities between Quincy and patients who are hospitalized and can’t easily communicate. Now, “we can track the folks who are on the CGM and intervene earlier than before,” said Dr. Tsimikas, who’s part of a clinical trial team testing CGM devices in two hospitals. “It’s almost like having another vital sign.
“It is only when we have all the data on all the other factors that can influence blood sugar, such as eating patterns, insulin dose and timing, and activity level that we can more accurately adjust the medical interventions.” This requires collaboration between all the groups involved in Quincy’s care. In koalas, the collaboration is with the veterinarian, koala zookeepers, dietitian, and the technology monitoring team. Whereas, for humans, we need parents, care providers, diabetes educators, dietitians, and physicians.
It’s not clear if Quincy will need his CGM for the rest of his life. If he’s stable on a specific insulin dose, Dr. Tsimikas said, he may not need it. But it sounds like eucalyptus smoothies will always be a vital part of his regimen.
In the name of thoroughness, take note that Quincy is not the first diabetic zoo animal whose care involved physicians from Scripps. “We have had several other consultations for animals with diabetes. Nearly 25 years ago, a roller-skating chimpanzee with diabetes was brought to the Scripps Whittier Institute labs for evaluation and treatment recommendations. A few years later, one of our medical directors, Alberto Hayek, MD, advised on the care of Lune, a diabetic baboon at the San Diego Zoo, for insulin management. This time we are making house calls to the zoo to treat Quincy in his home environment. Each animal experience offers opportunities to expand our knowledge about diabetes care and exchange approaches that we might not otherwise be aware of. This has been fun and rewarding. I am looking forward to seeing further outcomes from our interactions with Quincy,” according to Dr. Tsimikas.
Dr. Tsimikas reports that her center conducts research with Dexcom and Novo Nordisk. Dr. Singleton reports no relevant disclosures.
ASCO calls for expanding clinical trial eligibility
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials.
The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of participants, and include minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
“Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice,” ASCO President Monica M. Bertagnolli, MD, said in a statement. “These guidance documents help trial sponsors understand how to modernize eligibility criteria and ensure that trial participants more accurately reflect the patients who will receive a drug after approval.”
The two organizations launched an effort to update clinical trial eligibility criteria in 2016 and published a joint statement in 2017. The letter to the FDA and the rationale and instructions for expanding eligibility criteria in each of the five areas can be found here on the Friends of Cancer Research website.
SOURCE: Friends of Cancer and ASCO letter to the FDA.
Key clinical point: ASCO and Friends of Cancer have submitted draft recommendations to the FDA for expanding cancer clinical trial participation.
Major finding: The organizations recommend addressing minimum age requirements, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
Data source: Draft guidance produced by ASCO and Friends of Cancer Research and submitted to the FDA.
Disclosures: Individual members of the working groups were not listed and conflicts of interest were not disclosed.
Source: Friends of Cancer and ASCO letter to the FDA.