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Long-term follow-up results of ongoing trials highlighted at ACR 2018
A 5-year follow-up study comparing methods of meniscal tear management in patients with osteoarthritis kicks off the second Plenary Session on Monday, Oct. 22, at the annual meeting of the American College of Rheumatology.
Jeffrey N. Katz, MD, of Brigham and Women’s Hospital in Boston, and his colleagues conducted a long-term follow-up of patients from the METEOR study, the early results of which were presented at OARSI in 2017. Dr. Katz and his colleagues randomized patients with knee pain, meniscal tears, and OA changes on x-ray or MRI to physical therapy vs. physical therapy plus arthroscopic partial meniscectomy. After 5 years, pain relief was similar across treatment groups, supporting the short-term conclusion that these patients experience relief over time, irrespective of initial treatment. Overall, 25% of the patients had total knee replacement surgery during the follow-up period.
The session also includes a new presentation by Kenneth G. Saag, MD, of the University of Alabama at Birmingham of 2-year outcomes from a phase 3 trial of denosumab versus risedronate for glucocorticoid-induced osteoporosis that was first presented at EULAR this year.
At 2 years, denosumab proved superior for increasing spine and hip bone mineral density in osteoporosis patients, compared with risedronate, and demonstrated a similar safety profile.
In addition, attendees will hear updated long-term results from the SCOT trial of myeloablative autologous hematopoietic stem cell transplantation for scleroderma patients. Keith M. Sullivan, MD, of Duke University, Durham, N.C., and his colleagues found that the benefits of the treatment endured after 6-11 years, supporting results presented at ACR 2016.
A 5-year follow-up study comparing methods of meniscal tear management in patients with osteoarthritis kicks off the second Plenary Session on Monday, Oct. 22, at the annual meeting of the American College of Rheumatology.
Jeffrey N. Katz, MD, of Brigham and Women’s Hospital in Boston, and his colleagues conducted a long-term follow-up of patients from the METEOR study, the early results of which were presented at OARSI in 2017. Dr. Katz and his colleagues randomized patients with knee pain, meniscal tears, and OA changes on x-ray or MRI to physical therapy vs. physical therapy plus arthroscopic partial meniscectomy. After 5 years, pain relief was similar across treatment groups, supporting the short-term conclusion that these patients experience relief over time, irrespective of initial treatment. Overall, 25% of the patients had total knee replacement surgery during the follow-up period.
The session also includes a new presentation by Kenneth G. Saag, MD, of the University of Alabama at Birmingham of 2-year outcomes from a phase 3 trial of denosumab versus risedronate for glucocorticoid-induced osteoporosis that was first presented at EULAR this year.
At 2 years, denosumab proved superior for increasing spine and hip bone mineral density in osteoporosis patients, compared with risedronate, and demonstrated a similar safety profile.
In addition, attendees will hear updated long-term results from the SCOT trial of myeloablative autologous hematopoietic stem cell transplantation for scleroderma patients. Keith M. Sullivan, MD, of Duke University, Durham, N.C., and his colleagues found that the benefits of the treatment endured after 6-11 years, supporting results presented at ACR 2016.
A 5-year follow-up study comparing methods of meniscal tear management in patients with osteoarthritis kicks off the second Plenary Session on Monday, Oct. 22, at the annual meeting of the American College of Rheumatology.
Jeffrey N. Katz, MD, of Brigham and Women’s Hospital in Boston, and his colleagues conducted a long-term follow-up of patients from the METEOR study, the early results of which were presented at OARSI in 2017. Dr. Katz and his colleagues randomized patients with knee pain, meniscal tears, and OA changes on x-ray or MRI to physical therapy vs. physical therapy plus arthroscopic partial meniscectomy. After 5 years, pain relief was similar across treatment groups, supporting the short-term conclusion that these patients experience relief over time, irrespective of initial treatment. Overall, 25% of the patients had total knee replacement surgery during the follow-up period.
The session also includes a new presentation by Kenneth G. Saag, MD, of the University of Alabama at Birmingham of 2-year outcomes from a phase 3 trial of denosumab versus risedronate for glucocorticoid-induced osteoporosis that was first presented at EULAR this year.
At 2 years, denosumab proved superior for increasing spine and hip bone mineral density in osteoporosis patients, compared with risedronate, and demonstrated a similar safety profile.
In addition, attendees will hear updated long-term results from the SCOT trial of myeloablative autologous hematopoietic stem cell transplantation for scleroderma patients. Keith M. Sullivan, MD, of Duke University, Durham, N.C., and his colleagues found that the benefits of the treatment endured after 6-11 years, supporting results presented at ACR 2016.
REPORTING FROM THE ACR ANNUAL MEETING
Six PAD diagnostic tests vary widely in patients with diabetes
Six different clinical tests used to identify peripheral arterial disease (PAD) were found to be significantly different in their ability to detect PAD in a population of 50 patients with diabetes, according to a report published online in Primary Care Diabetes.
This study assessed the same group of participants with each of the following six tests: Doppler Waveform, toe-brachial pressure index (TBPI), ankle-brachial pressure index (ABPI), posterior tibial artery pulse (ATP), transcutaneous oxygen pressure (TCPO), and pulse palpation. The right and left foot were assessed in each participant, yeilding100 limbs for analysis, according to Yvonne Midolo Azzopardi, MD, of the University of Malta in Msida and her colleagues.
The highest percent of participants who were found to have PAD was 93%, as detected by Doppler Waveform, followed by TBPI (72%), ABPI (57%), ATP (35%), TCPO (30%), and pulse palpation (23%). The difference between these percentages was significant at P less than .0005.
“The reported observations suggest that use of only one screening tool in isolation could yield high false results since it is clear that these tests do not concur with each other to a large extent,” the authors stated.
Dr. Azzopardi and her colleagues pointed out that the use of more specialized tools, such as duplex scanning, could be compared with these six modalities to detect PAD but that such methods were unlikely to be routinely available to primary care physicians who are at the front lines of making the determination of PAD in patients with diabetes.
“The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which noninvasive screening modalities would yield the most valid results. This would significantly reduce the proportion of patients with diabetes who would be falsely identified as having no PAD and subsequently denied beneficial and effective secondary risk factor control,” Dr. Azzopardi and her colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Azzopardi YM et al. 2018. Prim Care Diabetes.. doi: 10.1016/j.pcd.2018.08.005.
Six different clinical tests used to identify peripheral arterial disease (PAD) were found to be significantly different in their ability to detect PAD in a population of 50 patients with diabetes, according to a report published online in Primary Care Diabetes.
This study assessed the same group of participants with each of the following six tests: Doppler Waveform, toe-brachial pressure index (TBPI), ankle-brachial pressure index (ABPI), posterior tibial artery pulse (ATP), transcutaneous oxygen pressure (TCPO), and pulse palpation. The right and left foot were assessed in each participant, yeilding100 limbs for analysis, according to Yvonne Midolo Azzopardi, MD, of the University of Malta in Msida and her colleagues.
The highest percent of participants who were found to have PAD was 93%, as detected by Doppler Waveform, followed by TBPI (72%), ABPI (57%), ATP (35%), TCPO (30%), and pulse palpation (23%). The difference between these percentages was significant at P less than .0005.
“The reported observations suggest that use of only one screening tool in isolation could yield high false results since it is clear that these tests do not concur with each other to a large extent,” the authors stated.
Dr. Azzopardi and her colleagues pointed out that the use of more specialized tools, such as duplex scanning, could be compared with these six modalities to detect PAD but that such methods were unlikely to be routinely available to primary care physicians who are at the front lines of making the determination of PAD in patients with diabetes.
“The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which noninvasive screening modalities would yield the most valid results. This would significantly reduce the proportion of patients with diabetes who would be falsely identified as having no PAD and subsequently denied beneficial and effective secondary risk factor control,” Dr. Azzopardi and her colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Azzopardi YM et al. 2018. Prim Care Diabetes.. doi: 10.1016/j.pcd.2018.08.005.
Six different clinical tests used to identify peripheral arterial disease (PAD) were found to be significantly different in their ability to detect PAD in a population of 50 patients with diabetes, according to a report published online in Primary Care Diabetes.
This study assessed the same group of participants with each of the following six tests: Doppler Waveform, toe-brachial pressure index (TBPI), ankle-brachial pressure index (ABPI), posterior tibial artery pulse (ATP), transcutaneous oxygen pressure (TCPO), and pulse palpation. The right and left foot were assessed in each participant, yeilding100 limbs for analysis, according to Yvonne Midolo Azzopardi, MD, of the University of Malta in Msida and her colleagues.
The highest percent of participants who were found to have PAD was 93%, as detected by Doppler Waveform, followed by TBPI (72%), ABPI (57%), ATP (35%), TCPO (30%), and pulse palpation (23%). The difference between these percentages was significant at P less than .0005.
“The reported observations suggest that use of only one screening tool in isolation could yield high false results since it is clear that these tests do not concur with each other to a large extent,” the authors stated.
Dr. Azzopardi and her colleagues pointed out that the use of more specialized tools, such as duplex scanning, could be compared with these six modalities to detect PAD but that such methods were unlikely to be routinely available to primary care physicians who are at the front lines of making the determination of PAD in patients with diabetes.
“The authors advocate for urgent, more robust studies utilizing a gold standard modality for the diagnosis of PAD in order to provide evidence regarding which noninvasive screening modalities would yield the most valid results. This would significantly reduce the proportion of patients with diabetes who would be falsely identified as having no PAD and subsequently denied beneficial and effective secondary risk factor control,” Dr. Azzopardi and her colleagues concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Azzopardi YM et al. 2018. Prim Care Diabetes.. doi: 10.1016/j.pcd.2018.08.005.
FROM PRIMARY CARE DIABETES
Key clinical point: Six different tests used to identify PAD differed significantly in their ability to detect the disease.
Major finding: Detection ranged from 93% to 23% in the same group of patients.
Study details: Both legs of 50 patients with diabetes were assessed for PAD using six screening modalities.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Azzopardi YM et al. 2018. Prim Care Diabetes. doi: 10.1016/j.pcd.2018.08.005.
Get your MACRA updates here at ACR 2018
MACRA! MIPS! APMs! Confused? You won’t be after a Sunday morning session at this year’s annual meeting of the American College of Rheumatology.
Zachary S. Wallace, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, moderates a panel that will answer your questions about the state of the Quality Payment Program (QPP).
The session will review the updates made to the QPP for 2019 and let attendees know what tools are available to help them maximize payments under each of the tracks. The session also will provide an update on the physician-focused alternative payment model (APM) for rheumatoid arthritis that has been developed by the ACR and submitted to the Physician-Focused Payment Model Technical Advisory Committee for review. Read in depth here about the details of the ACR’s physician-focused APM as it was presented at last year’s annual meeting.
And if you don’t like what you hear about these programs, attendees will provide information on how to provide feedback to the agency to let your voice be heard when the QPP comes up for its annual update.
Sustain Your Practice: 2018 Medicare Update on MACRA and APMs
Sunday, Oct. 21, 9:00 a.m.–10:00 a.m.
MACRA! MIPS! APMs! Confused? You won’t be after a Sunday morning session at this year’s annual meeting of the American College of Rheumatology.
Zachary S. Wallace, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, moderates a panel that will answer your questions about the state of the Quality Payment Program (QPP).
The session will review the updates made to the QPP for 2019 and let attendees know what tools are available to help them maximize payments under each of the tracks. The session also will provide an update on the physician-focused alternative payment model (APM) for rheumatoid arthritis that has been developed by the ACR and submitted to the Physician-Focused Payment Model Technical Advisory Committee for review. Read in depth here about the details of the ACR’s physician-focused APM as it was presented at last year’s annual meeting.
And if you don’t like what you hear about these programs, attendees will provide information on how to provide feedback to the agency to let your voice be heard when the QPP comes up for its annual update.
Sustain Your Practice: 2018 Medicare Update on MACRA and APMs
Sunday, Oct. 21, 9:00 a.m.–10:00 a.m.
MACRA! MIPS! APMs! Confused? You won’t be after a Sunday morning session at this year’s annual meeting of the American College of Rheumatology.
Zachary S. Wallace, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, moderates a panel that will answer your questions about the state of the Quality Payment Program (QPP).
The session will review the updates made to the QPP for 2019 and let attendees know what tools are available to help them maximize payments under each of the tracks. The session also will provide an update on the physician-focused alternative payment model (APM) for rheumatoid arthritis that has been developed by the ACR and submitted to the Physician-Focused Payment Model Technical Advisory Committee for review. Read in depth here about the details of the ACR’s physician-focused APM as it was presented at last year’s annual meeting.
And if you don’t like what you hear about these programs, attendees will provide information on how to provide feedback to the agency to let your voice be heard when the QPP comes up for its annual update.
Sustain Your Practice: 2018 Medicare Update on MACRA and APMs
Sunday, Oct. 21, 9:00 a.m.–10:00 a.m.
REPORTING FROM THE ACR ANNUAL MEETING
Obesity tied to improved inpatient survival of patients with PAD
The obesity paradox appears alive and well in the treatment of peripheral arterial disease (PAD), according to the results of a 10-year, 5.6-million patient database study.
The researchers found that coding for obesity is associated with lower in-hospital mortality in PAD patients relative to those who were normal weight or overweight. This obesity survival paradox was independent of age, sex, and comorbidities and was seen in all obesity classes, according to Karsten Keller, MD, of the University Medical Center Mainz (Germany), and his colleagues.
In total, 5,611,827 inpatients aged 18 years or older with PAD were treated between 2005 and 2015 in Germany, 5,611,484 of whom (64.8% men) were eligible for analysis. Among these, 500,027 (8.9%) were coded with obesity and 16,620 (0.3%) were coded as underweight; 5,094,837 (90.8%) were in neither classification (considered healthy/overweight) and served as the reference group for comparison, according to Dr. Keller and his colleagues.
Obese PAD patients were younger, more frequently women, and had less cancer but were diagnosed more often with cardiovascular disease risk factors such as diabetes and hypertension, compared with the reference group. In addition, there were higher levels of coronary artery disease, heart failure, renal insufficiency, and chronic obstructive pulmonary disease (COPD) in obese patients.
Obese patients had lower mortality (3.2% vs. 5.1%; P less than .001), compared with the reference group, and showed a reduced risk of in-hospital mortality (odds ratio, 0.617; P less than .001). Univariate logistic regression analyses showed the association of obesity and reduced in-hospital mortality was consistent and significant, even with adjustment for age, sex, and comorbidities.
In contrast, underweight patients were significantly more likely to die than those in the reference group (6% vs. 5.1%; P less than .001), according to the researchers. Underweight was associated with an increased risk for in-hospital mortality (OR, 1.18; P less than .001), and this was consistent throughout univariate analysis.
Underweight PAD patients also had significantly higher frequencies of cancer and COPD, but lower rates of diabetes mellitus, hypertension, coronary artery disease, and heart failure, compared with the reference group. Both obese and underweight PAD patients stayed longer in the hospital than the PAD patients who were not coded as underweight or obese.
Obese PAD patients had slight but significantly higher rates of MI (3.9% vs. 3.4%; P less than .001) and venous thromboembolic events, and more often had to undergo amputation surgery (8.3% vs. 8.1%; P less than .001), including a higher relative number of minor amputations (6.3% vs. 5.5%; P less than .001). However, major amputation rates were significantly lower in obese patients (2.6% vs. 3.2%; P less than .001), with univariate analysis showing a significant association between obesity and a lower risk of major amputation (OR, 0.82; P less than .001), which remained stable after multivariate adjustment.
Limitations of the study reported by the researchers included a lower than expected percent obesity in the 10-year database, compared with current rates, and the inability to follow tobacco use or to determine the socioeconomic status of the patients.
“Obesity is associated with lower in-hospital mortality in PAD patients relative to those with normal weight/overweight. ... Therefore, greater concern should be directed to the thinner patients with PAD who are particularly at increased risk of mortality,” the researchers concluded.
This study was supported by the German Federal Ministry of Education and Research; the authors reported that they had no disclosures.
SOURCE: Keller K et al. Clin Nutr. 2018 Oct 3. doi: 10.1016/j.clnu.2018.09.031.
The obesity paradox appears alive and well in the treatment of peripheral arterial disease (PAD), according to the results of a 10-year, 5.6-million patient database study.
The researchers found that coding for obesity is associated with lower in-hospital mortality in PAD patients relative to those who were normal weight or overweight. This obesity survival paradox was independent of age, sex, and comorbidities and was seen in all obesity classes, according to Karsten Keller, MD, of the University Medical Center Mainz (Germany), and his colleagues.
In total, 5,611,827 inpatients aged 18 years or older with PAD were treated between 2005 and 2015 in Germany, 5,611,484 of whom (64.8% men) were eligible for analysis. Among these, 500,027 (8.9%) were coded with obesity and 16,620 (0.3%) were coded as underweight; 5,094,837 (90.8%) were in neither classification (considered healthy/overweight) and served as the reference group for comparison, according to Dr. Keller and his colleagues.
Obese PAD patients were younger, more frequently women, and had less cancer but were diagnosed more often with cardiovascular disease risk factors such as diabetes and hypertension, compared with the reference group. In addition, there were higher levels of coronary artery disease, heart failure, renal insufficiency, and chronic obstructive pulmonary disease (COPD) in obese patients.
Obese patients had lower mortality (3.2% vs. 5.1%; P less than .001), compared with the reference group, and showed a reduced risk of in-hospital mortality (odds ratio, 0.617; P less than .001). Univariate logistic regression analyses showed the association of obesity and reduced in-hospital mortality was consistent and significant, even with adjustment for age, sex, and comorbidities.
In contrast, underweight patients were significantly more likely to die than those in the reference group (6% vs. 5.1%; P less than .001), according to the researchers. Underweight was associated with an increased risk for in-hospital mortality (OR, 1.18; P less than .001), and this was consistent throughout univariate analysis.
Underweight PAD patients also had significantly higher frequencies of cancer and COPD, but lower rates of diabetes mellitus, hypertension, coronary artery disease, and heart failure, compared with the reference group. Both obese and underweight PAD patients stayed longer in the hospital than the PAD patients who were not coded as underweight or obese.
Obese PAD patients had slight but significantly higher rates of MI (3.9% vs. 3.4%; P less than .001) and venous thromboembolic events, and more often had to undergo amputation surgery (8.3% vs. 8.1%; P less than .001), including a higher relative number of minor amputations (6.3% vs. 5.5%; P less than .001). However, major amputation rates were significantly lower in obese patients (2.6% vs. 3.2%; P less than .001), with univariate analysis showing a significant association between obesity and a lower risk of major amputation (OR, 0.82; P less than .001), which remained stable after multivariate adjustment.
Limitations of the study reported by the researchers included a lower than expected percent obesity in the 10-year database, compared with current rates, and the inability to follow tobacco use or to determine the socioeconomic status of the patients.
“Obesity is associated with lower in-hospital mortality in PAD patients relative to those with normal weight/overweight. ... Therefore, greater concern should be directed to the thinner patients with PAD who are particularly at increased risk of mortality,” the researchers concluded.
This study was supported by the German Federal Ministry of Education and Research; the authors reported that they had no disclosures.
SOURCE: Keller K et al. Clin Nutr. 2018 Oct 3. doi: 10.1016/j.clnu.2018.09.031.
The obesity paradox appears alive and well in the treatment of peripheral arterial disease (PAD), according to the results of a 10-year, 5.6-million patient database study.
The researchers found that coding for obesity is associated with lower in-hospital mortality in PAD patients relative to those who were normal weight or overweight. This obesity survival paradox was independent of age, sex, and comorbidities and was seen in all obesity classes, according to Karsten Keller, MD, of the University Medical Center Mainz (Germany), and his colleagues.
In total, 5,611,827 inpatients aged 18 years or older with PAD were treated between 2005 and 2015 in Germany, 5,611,484 of whom (64.8% men) were eligible for analysis. Among these, 500,027 (8.9%) were coded with obesity and 16,620 (0.3%) were coded as underweight; 5,094,837 (90.8%) were in neither classification (considered healthy/overweight) and served as the reference group for comparison, according to Dr. Keller and his colleagues.
Obese PAD patients were younger, more frequently women, and had less cancer but were diagnosed more often with cardiovascular disease risk factors such as diabetes and hypertension, compared with the reference group. In addition, there were higher levels of coronary artery disease, heart failure, renal insufficiency, and chronic obstructive pulmonary disease (COPD) in obese patients.
Obese patients had lower mortality (3.2% vs. 5.1%; P less than .001), compared with the reference group, and showed a reduced risk of in-hospital mortality (odds ratio, 0.617; P less than .001). Univariate logistic regression analyses showed the association of obesity and reduced in-hospital mortality was consistent and significant, even with adjustment for age, sex, and comorbidities.
In contrast, underweight patients were significantly more likely to die than those in the reference group (6% vs. 5.1%; P less than .001), according to the researchers. Underweight was associated with an increased risk for in-hospital mortality (OR, 1.18; P less than .001), and this was consistent throughout univariate analysis.
Underweight PAD patients also had significantly higher frequencies of cancer and COPD, but lower rates of diabetes mellitus, hypertension, coronary artery disease, and heart failure, compared with the reference group. Both obese and underweight PAD patients stayed longer in the hospital than the PAD patients who were not coded as underweight or obese.
Obese PAD patients had slight but significantly higher rates of MI (3.9% vs. 3.4%; P less than .001) and venous thromboembolic events, and more often had to undergo amputation surgery (8.3% vs. 8.1%; P less than .001), including a higher relative number of minor amputations (6.3% vs. 5.5%; P less than .001). However, major amputation rates were significantly lower in obese patients (2.6% vs. 3.2%; P less than .001), with univariate analysis showing a significant association between obesity and a lower risk of major amputation (OR, 0.82; P less than .001), which remained stable after multivariate adjustment.
Limitations of the study reported by the researchers included a lower than expected percent obesity in the 10-year database, compared with current rates, and the inability to follow tobacco use or to determine the socioeconomic status of the patients.
“Obesity is associated with lower in-hospital mortality in PAD patients relative to those with normal weight/overweight. ... Therefore, greater concern should be directed to the thinner patients with PAD who are particularly at increased risk of mortality,” the researchers concluded.
This study was supported by the German Federal Ministry of Education and Research; the authors reported that they had no disclosures.
SOURCE: Keller K et al. Clin Nutr. 2018 Oct 3. doi: 10.1016/j.clnu.2018.09.031.
FROM CLINICAL NUTRITION
Key clinical point: Obesity is associated with lower in-hospital mortality in patients with peripheral arterial disease relative to those who were healthy weight or overweight.
Major finding: Obese patients had a lower mortality (3.2% vs. 5.1%; P less than .001), compared with the reference group.
Study details: A database study of 5,611,484 inpatients diagnosed with peripheral arterial disease.
Disclosures: This study was supported by the German Federal Ministry of Education and Research; the authors reported that they had no disclosures.
Source: Keller K et al. Clin Nutr. 2018 Oct 3. doi: 10.1016/j.clnu.2018.09.031.
Superheroes
Who’s your favorite superhero? I realize this might be impossible to answer – Marvel and DC Comics alone have thousands of heroes from which to choose. I recently visited the Seattle Museum of Pop Culture, known as MoPOP, where they have an awesome exhibit on the history of Marvel. I left understanding why superheroes are perennially popular and why we need them. I also felt a little more powerful myself.
The Avengers might seem like just a marketing scheme created to take your movie money. They’re more than that. Superheroes like Thor and Black Widow appear in all cultures and throughout time. There are short and tall, black and white, young and old, gay and straight, Muslim and Jewish, European, Asian, and African superheroes. The characters in The Iliad were superheroes to the ancients. In India today, you can buy comics featuring Lord Shiva.
Superheroes change with time, often reflecting our struggles and values. Captain America was created in 1941 to allay our fear of the then-metastasizing Nazis. The most popular Marvel hero at the MoPOP right now is Black Panther. Next year Captain Marvel will be released. Also known as Carol Danvers, Captain Marvel is one of Marvel Comics’ strongest women, a female Air Force officer with superhuman strength and speed.
Heroes change with the times and are metaphors for the real-life challenges we face and our abilities to overcome them. Superhero stories are our own stories.
When I was a kid, Spider-Man was my favorite. I watched him every afternoon at 3 o’clock when I got home from school. Spidey is a nerdy, little kid who can perform amazing feats to keep people safe and to right societal wrongs. Being a little kid who similarly loved science, he seemed like a good role model at the time. Interestingly, Spidey might have helped me. A couple of studies have shown that kids who pretend to be superheroes, like Batman for example, perform better on tasks, compared with those who aren’t pretending. In some ways, this strategy of imagining to have superpowers is an antidote to the impostor syndrome, a common experience of feeling powerless and undeserving of your position or role. By imagining that they have superpowers, children behave commensurately with these beliefs, which can help them develop self-efficacy at a critical period of development.
This strategy can work for adults too. Military men and women will adopt heroes like Punisher for their battalions, surgeons will don Superman scrub caps, and athletes will take nicknames like Batman for their professional personas. It is a strategy our ancient ancestors deployed, imagining they had the power of Hercules going into battle. No doubt, the energizing, empowering emotion we feel when we think of superheroes is why they are still so popular today. It is why you walk with a bit more swagger when you exit the theater of a good hero flick.
So indulge in a little Wonder Woman and Daredevil and Jessica Jones, even after Halloween has passed. When you do, remember they are here because they are us. and one that we need.
Nowadays, I probably relate most to Captain America: Lead a team, help make each team member better. And, yet, looking at Chris Evans, the actor who plays Captain America, it’s clear I need a lot more time at the gym. Or maybe I could just try to get bitten by a spider.
“Can he swing from a thread? Take a look overhead. Hey, there, there goes the Spider-Man!”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Who’s your favorite superhero? I realize this might be impossible to answer – Marvel and DC Comics alone have thousands of heroes from which to choose. I recently visited the Seattle Museum of Pop Culture, known as MoPOP, where they have an awesome exhibit on the history of Marvel. I left understanding why superheroes are perennially popular and why we need them. I also felt a little more powerful myself.
The Avengers might seem like just a marketing scheme created to take your movie money. They’re more than that. Superheroes like Thor and Black Widow appear in all cultures and throughout time. There are short and tall, black and white, young and old, gay and straight, Muslim and Jewish, European, Asian, and African superheroes. The characters in The Iliad were superheroes to the ancients. In India today, you can buy comics featuring Lord Shiva.
Superheroes change with time, often reflecting our struggles and values. Captain America was created in 1941 to allay our fear of the then-metastasizing Nazis. The most popular Marvel hero at the MoPOP right now is Black Panther. Next year Captain Marvel will be released. Also known as Carol Danvers, Captain Marvel is one of Marvel Comics’ strongest women, a female Air Force officer with superhuman strength and speed.
Heroes change with the times and are metaphors for the real-life challenges we face and our abilities to overcome them. Superhero stories are our own stories.
When I was a kid, Spider-Man was my favorite. I watched him every afternoon at 3 o’clock when I got home from school. Spidey is a nerdy, little kid who can perform amazing feats to keep people safe and to right societal wrongs. Being a little kid who similarly loved science, he seemed like a good role model at the time. Interestingly, Spidey might have helped me. A couple of studies have shown that kids who pretend to be superheroes, like Batman for example, perform better on tasks, compared with those who aren’t pretending. In some ways, this strategy of imagining to have superpowers is an antidote to the impostor syndrome, a common experience of feeling powerless and undeserving of your position or role. By imagining that they have superpowers, children behave commensurately with these beliefs, which can help them develop self-efficacy at a critical period of development.
This strategy can work for adults too. Military men and women will adopt heroes like Punisher for their battalions, surgeons will don Superman scrub caps, and athletes will take nicknames like Batman for their professional personas. It is a strategy our ancient ancestors deployed, imagining they had the power of Hercules going into battle. No doubt, the energizing, empowering emotion we feel when we think of superheroes is why they are still so popular today. It is why you walk with a bit more swagger when you exit the theater of a good hero flick.
So indulge in a little Wonder Woman and Daredevil and Jessica Jones, even after Halloween has passed. When you do, remember they are here because they are us. and one that we need.
Nowadays, I probably relate most to Captain America: Lead a team, help make each team member better. And, yet, looking at Chris Evans, the actor who plays Captain America, it’s clear I need a lot more time at the gym. Or maybe I could just try to get bitten by a spider.
“Can he swing from a thread? Take a look overhead. Hey, there, there goes the Spider-Man!”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Who’s your favorite superhero? I realize this might be impossible to answer – Marvel and DC Comics alone have thousands of heroes from which to choose. I recently visited the Seattle Museum of Pop Culture, known as MoPOP, where they have an awesome exhibit on the history of Marvel. I left understanding why superheroes are perennially popular and why we need them. I also felt a little more powerful myself.
The Avengers might seem like just a marketing scheme created to take your movie money. They’re more than that. Superheroes like Thor and Black Widow appear in all cultures and throughout time. There are short and tall, black and white, young and old, gay and straight, Muslim and Jewish, European, Asian, and African superheroes. The characters in The Iliad were superheroes to the ancients. In India today, you can buy comics featuring Lord Shiva.
Superheroes change with time, often reflecting our struggles and values. Captain America was created in 1941 to allay our fear of the then-metastasizing Nazis. The most popular Marvel hero at the MoPOP right now is Black Panther. Next year Captain Marvel will be released. Also known as Carol Danvers, Captain Marvel is one of Marvel Comics’ strongest women, a female Air Force officer with superhuman strength and speed.
Heroes change with the times and are metaphors for the real-life challenges we face and our abilities to overcome them. Superhero stories are our own stories.
When I was a kid, Spider-Man was my favorite. I watched him every afternoon at 3 o’clock when I got home from school. Spidey is a nerdy, little kid who can perform amazing feats to keep people safe and to right societal wrongs. Being a little kid who similarly loved science, he seemed like a good role model at the time. Interestingly, Spidey might have helped me. A couple of studies have shown that kids who pretend to be superheroes, like Batman for example, perform better on tasks, compared with those who aren’t pretending. In some ways, this strategy of imagining to have superpowers is an antidote to the impostor syndrome, a common experience of feeling powerless and undeserving of your position or role. By imagining that they have superpowers, children behave commensurately with these beliefs, which can help them develop self-efficacy at a critical period of development.
This strategy can work for adults too. Military men and women will adopt heroes like Punisher for their battalions, surgeons will don Superman scrub caps, and athletes will take nicknames like Batman for their professional personas. It is a strategy our ancient ancestors deployed, imagining they had the power of Hercules going into battle. No doubt, the energizing, empowering emotion we feel when we think of superheroes is why they are still so popular today. It is why you walk with a bit more swagger when you exit the theater of a good hero flick.
So indulge in a little Wonder Woman and Daredevil and Jessica Jones, even after Halloween has passed. When you do, remember they are here because they are us. and one that we need.
Nowadays, I probably relate most to Captain America: Lead a team, help make each team member better. And, yet, looking at Chris Evans, the actor who plays Captain America, it’s clear I need a lot more time at the gym. Or maybe I could just try to get bitten by a spider.
“Can he swing from a thread? Take a look overhead. Hey, there, there goes the Spider-Man!”
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
How much more proof do you need?
One piece of wisdom I was given in medical school was to never be the first nor the last to adopt a new treatment. The history of medicine is full of new discoveries that don’t work out as well as the first report. It also is full of long standing dogmas that later were proven false. This balancing act is part of being a professional and being an advocate for your patient. There is science behind this art. Everett Rogers identified innovators, early adopters, and laggards as new ideas are diffused into practice.1
A 2007 French study2 that investigated oral amoxicillin for early-onset group B streptococcal (GBS) disease is one of the few times in the past 3 decades in which I changed my practice based on a single article. It was a large, conclusive study with 222 patients, so it doesn’t need a meta-analysis like American research often requires. The research showed that most of what I had been taught about oral amoxicillin was false. Amoxicillin is absorbed well even at doses above 50 mg/kg per day. It is absorbed reliably by full term neonates, even mildly sick ones. It does adequately cross the blood-brain barrier. The French researchers measured serum levels and proved all this using both scientific principles and through a clinical trial.
I have used this oral protocol (10 days total after 2-3 days IV therapy) on two occasions to treat GBS sepsis when I had informed consent of the parents and buy-in from the primary care pediatrician to be early adopters. I expected the Red Book would update its recommendations. That didn’t happen.
Meanwhile, I have seen other babies kept for 10 days in the hospital for IV therapy with resultant wasted costs (about $20 million/year in the United States) and income loss for the parents. I’ve treated complications and readmissions caused by peripherally inserted central catheter (PICC) line issues. One baby at home got a syringe of gentamicin given as an IV push instead of a normal saline flush. Mistakes happen at home and in the hospital.
Because late-onset GBS can be acquired environmentally, there always will be recurrences. Unless you are practicing defensive medicine, the issue isn’t the rate of recurrence; it is whether the more invasive intervention of prolonged IV therapy reduces that rate. Then balance any measured reduction (which apparently is zero) against the adverse effects of the invasive intervention, such as PICC line infections. This Bayesian decision making is hard for some risk-averse humans to assimilate. (I’m part Borg.)
Coon et al.3 have confirmed, using big data, that prolonged IV therapy of uncomplicated, late-onset GBS bacteremia does not generate a clinically significant benefit. It certainly is possible to sow doubt by asking for proof in a variety of subpopulations. Even in the era of intrapartum antibiotic prophylaxis, which has halved the incidence of GBS disease, GBS disease occurs in about 2,000 babies per year in the United States. However, most are treated in community hospitals and are not included in the database used in this new report. With fewer than 2-3 cases of GBS bacteremia per year per hospital, a multicenter, randomized controlled trial would be an unprecedented undertaking, is ethically problematic, and is not realistically happening soon. So these observational data, skillfully acquired and analyzed, are and will remain the best available data.
This new article is in the context of multiple articles over the past decade that have disproven the myth of the superiority of IV therapy. Given the known risks and costs of PICC lines and prolonged IV therapy, the default should be, absent a credible rationale to the contrary, that oral therapy at home is better.
Coon et al. show that, by 2015, 5 of 49 children’s hospitals (10%) were early adopters and had already made the switch to mostly using short treatment courses for uncomplicated GBS bacteremia; 14 of 49 (29%) hadn’t changed at all from the obsolete Red Book recommendation. Given this new analysis, what are you laggards4 waiting for?
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Diffusion of Innovations,” 5th ed. (New York: Free Press, 2003).
2. Eur J Clin Pharmacol. 2007 Jul;63(7):657-62.
3. Pediatrics. 2018;142(5):e20180345.
4. https://en.wikipedia.org/wiki/Diffusion_of_innovations.
One piece of wisdom I was given in medical school was to never be the first nor the last to adopt a new treatment. The history of medicine is full of new discoveries that don’t work out as well as the first report. It also is full of long standing dogmas that later were proven false. This balancing act is part of being a professional and being an advocate for your patient. There is science behind this art. Everett Rogers identified innovators, early adopters, and laggards as new ideas are diffused into practice.1
A 2007 French study2 that investigated oral amoxicillin for early-onset group B streptococcal (GBS) disease is one of the few times in the past 3 decades in which I changed my practice based on a single article. It was a large, conclusive study with 222 patients, so it doesn’t need a meta-analysis like American research often requires. The research showed that most of what I had been taught about oral amoxicillin was false. Amoxicillin is absorbed well even at doses above 50 mg/kg per day. It is absorbed reliably by full term neonates, even mildly sick ones. It does adequately cross the blood-brain barrier. The French researchers measured serum levels and proved all this using both scientific principles and through a clinical trial.
I have used this oral protocol (10 days total after 2-3 days IV therapy) on two occasions to treat GBS sepsis when I had informed consent of the parents and buy-in from the primary care pediatrician to be early adopters. I expected the Red Book would update its recommendations. That didn’t happen.
Meanwhile, I have seen other babies kept for 10 days in the hospital for IV therapy with resultant wasted costs (about $20 million/year in the United States) and income loss for the parents. I’ve treated complications and readmissions caused by peripherally inserted central catheter (PICC) line issues. One baby at home got a syringe of gentamicin given as an IV push instead of a normal saline flush. Mistakes happen at home and in the hospital.
Because late-onset GBS can be acquired environmentally, there always will be recurrences. Unless you are practicing defensive medicine, the issue isn’t the rate of recurrence; it is whether the more invasive intervention of prolonged IV therapy reduces that rate. Then balance any measured reduction (which apparently is zero) against the adverse effects of the invasive intervention, such as PICC line infections. This Bayesian decision making is hard for some risk-averse humans to assimilate. (I’m part Borg.)
Coon et al.3 have confirmed, using big data, that prolonged IV therapy of uncomplicated, late-onset GBS bacteremia does not generate a clinically significant benefit. It certainly is possible to sow doubt by asking for proof in a variety of subpopulations. Even in the era of intrapartum antibiotic prophylaxis, which has halved the incidence of GBS disease, GBS disease occurs in about 2,000 babies per year in the United States. However, most are treated in community hospitals and are not included in the database used in this new report. With fewer than 2-3 cases of GBS bacteremia per year per hospital, a multicenter, randomized controlled trial would be an unprecedented undertaking, is ethically problematic, and is not realistically happening soon. So these observational data, skillfully acquired and analyzed, are and will remain the best available data.
This new article is in the context of multiple articles over the past decade that have disproven the myth of the superiority of IV therapy. Given the known risks and costs of PICC lines and prolonged IV therapy, the default should be, absent a credible rationale to the contrary, that oral therapy at home is better.
Coon et al. show that, by 2015, 5 of 49 children’s hospitals (10%) were early adopters and had already made the switch to mostly using short treatment courses for uncomplicated GBS bacteremia; 14 of 49 (29%) hadn’t changed at all from the obsolete Red Book recommendation. Given this new analysis, what are you laggards4 waiting for?
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Diffusion of Innovations,” 5th ed. (New York: Free Press, 2003).
2. Eur J Clin Pharmacol. 2007 Jul;63(7):657-62.
3. Pediatrics. 2018;142(5):e20180345.
4. https://en.wikipedia.org/wiki/Diffusion_of_innovations.
One piece of wisdom I was given in medical school was to never be the first nor the last to adopt a new treatment. The history of medicine is full of new discoveries that don’t work out as well as the first report. It also is full of long standing dogmas that later were proven false. This balancing act is part of being a professional and being an advocate for your patient. There is science behind this art. Everett Rogers identified innovators, early adopters, and laggards as new ideas are diffused into practice.1
A 2007 French study2 that investigated oral amoxicillin for early-onset group B streptococcal (GBS) disease is one of the few times in the past 3 decades in which I changed my practice based on a single article. It was a large, conclusive study with 222 patients, so it doesn’t need a meta-analysis like American research often requires. The research showed that most of what I had been taught about oral amoxicillin was false. Amoxicillin is absorbed well even at doses above 50 mg/kg per day. It is absorbed reliably by full term neonates, even mildly sick ones. It does adequately cross the blood-brain barrier. The French researchers measured serum levels and proved all this using both scientific principles and through a clinical trial.
I have used this oral protocol (10 days total after 2-3 days IV therapy) on two occasions to treat GBS sepsis when I had informed consent of the parents and buy-in from the primary care pediatrician to be early adopters. I expected the Red Book would update its recommendations. That didn’t happen.
Meanwhile, I have seen other babies kept for 10 days in the hospital for IV therapy with resultant wasted costs (about $20 million/year in the United States) and income loss for the parents. I’ve treated complications and readmissions caused by peripherally inserted central catheter (PICC) line issues. One baby at home got a syringe of gentamicin given as an IV push instead of a normal saline flush. Mistakes happen at home and in the hospital.
Because late-onset GBS can be acquired environmentally, there always will be recurrences. Unless you are practicing defensive medicine, the issue isn’t the rate of recurrence; it is whether the more invasive intervention of prolonged IV therapy reduces that rate. Then balance any measured reduction (which apparently is zero) against the adverse effects of the invasive intervention, such as PICC line infections. This Bayesian decision making is hard for some risk-averse humans to assimilate. (I’m part Borg.)
Coon et al.3 have confirmed, using big data, that prolonged IV therapy of uncomplicated, late-onset GBS bacteremia does not generate a clinically significant benefit. It certainly is possible to sow doubt by asking for proof in a variety of subpopulations. Even in the era of intrapartum antibiotic prophylaxis, which has halved the incidence of GBS disease, GBS disease occurs in about 2,000 babies per year in the United States. However, most are treated in community hospitals and are not included in the database used in this new report. With fewer than 2-3 cases of GBS bacteremia per year per hospital, a multicenter, randomized controlled trial would be an unprecedented undertaking, is ethically problematic, and is not realistically happening soon. So these observational data, skillfully acquired and analyzed, are and will remain the best available data.
This new article is in the context of multiple articles over the past decade that have disproven the myth of the superiority of IV therapy. Given the known risks and costs of PICC lines and prolonged IV therapy, the default should be, absent a credible rationale to the contrary, that oral therapy at home is better.
Coon et al. show that, by 2015, 5 of 49 children’s hospitals (10%) were early adopters and had already made the switch to mostly using short treatment courses for uncomplicated GBS bacteremia; 14 of 49 (29%) hadn’t changed at all from the obsolete Red Book recommendation. Given this new analysis, what are you laggards4 waiting for?
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
References
1. “Diffusion of Innovations,” 5th ed. (New York: Free Press, 2003).
2. Eur J Clin Pharmacol. 2007 Jul;63(7):657-62.
3. Pediatrics. 2018;142(5):e20180345.
4. https://en.wikipedia.org/wiki/Diffusion_of_innovations.
The Sunshine Act, 5 years hence
You may recall that . The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.
Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.
Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.
One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.
Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*
All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)
Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.
If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.
You may recall that . The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.
Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.
Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.
One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.
Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*
All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)
Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.
If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.
You may recall that . The intent was to make relationships between pharmaceutical manufacturers and health care providers more transparent, by requiring the manufacturers to report to the Centers for Medicare & Medicaid Services all payments and other “transfers of value” provided to physicians and teaching hospitals.
Since the CMS has been collecting this information (and publishing it online each September) for 5 years now, I thought I would have a look at what has been learned to date, and what may have changed as a result.
Not much, apparently. In 2014, I predicted that attorneys, activists, and the occasional investigative reporter might peruse the data for their own purposes, but the general public would have little curiosity or use for the information. That appears to be the case thus far; there is no evidence that significant numbers of ordinary citizens have looked at the data or drawn any conclusions from it, perhaps because of the difficulty in accessing it (the website was widely panned when it debuted, although improvements have since been made); or perhaps because neither the CMS nor anyone else has offered the public any assistance in interpreting the raw data. Whether patients think less of doctors who accept an occasional industry-sponsored lunch for their employees, or think more (or less) of those who educate other providers or conduct clinical research, remain open questions.
One measurable – and probably unintended – consequence has been the increasing reluctance of physicians to provide legitimate feedback, or otherwise interact at all with industry, probably out of fear that they might one day have to explain a payment that could be construed by someone with an ax to grind as a conflict of interest. This is a shame, since there is no better way to develop new therapies, or to design solutions to the huge problems facing modern health care, than to actively involve doctors.
Furthermore, it is not clear how well the industry has complied with the law, or how effectively the government is enforcing it. The law authorizes fines of up to $150,000 annually, rising to $1 million for intentional violations; and while Vermont announced in late 2013 that it had levied 25 fines totaling $61,250 for violations of its somewhat stricter version of the statute, I could find no evidence of any similar enforcement by the CMS or any of the other states with standalone conflict of interest laws.*
All of that said, the law’s questionable impact and apparent lack of enforcement do not mean you can ignore it. Increased transparency and scrutiny of physician financial interests apparently are here to stay. The data are still being collected and displayed for anyone to see, so you still want to be certain that what is reported about you is accurate. This means keeping your own records of any money, food, or supplies that you receive from any pharmaceutical company, and making certain that it is in fact your information – and not someone else’s – that is published. (The CMS initially released a free smartphone application to facilitate that independent record-keeping process, but the app apparently is no longer available.)
Since all data must be reported to the CMS by March 31 annually, you need to set aside some time each April or May to review this information. If you have many (or complex) industry relationships, you should probably contact each manufacturer in January or February and ask to see the information before it is submitted. Then, review it again after the CMS gets it, to be sure that nothing has changed. You do have 2 years after the data go live to pursue corrections, but in the interim, the incorrect information remains online; so it’s best to fix it in advance of publication.
If you don’t see drug reps, accept office lunches, attend industry dinners, or give sponsored talks, don’t assume that you are not included in the database. Check anyway; you might be indirectly involved in a compensation that you were not aware of, or you may have been reported in error.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
*California, Colorado, Maine, Massachusetts, Minnesota, Vermont, West Virginia, and the District of Columbia had their own laws in place addressing industry relationships with providers before the ACA was enacted. Maine repealed its law in 2011.
Fat attenuation index boosts coronary CT prognostication
MUNICH – The perivascular fat attenuation index, a new measure of coronary plaque inflammation using data collected by a conventional coronary CT scan, identified an elevated risk for future cardiovascular death that was independent of standard risk factors in both derivation and validation studies with prospective data from more than 3,900 patients.
Patients with a high fat attenuation index (FAI) in the perivascular fat surrounding their right coronary artery had a five- to ninefold higher risk of cardiac mortality during 4-6 years of follow-up than did those with lower scores, after adjustment for conventional risk factors and standard findings from the coronary CT, Charalambos Antoniades, MD, said at the annual congress of the European Society of Cardiology.
The FAI is a “powerful, novel technology for cardiovascular disease risk stratification. It has striking prognostic value for cardiac death and nonfatal MI over and above other risk scores and state-of-the-art interpretation of coronary CT angiography,” said Dr. Antoniades, professor of cardiovascular medicine at the University of Oxford (England). He also highlighted that the data he reported suggested a protective effect in patients with a high FAI who received treatment with aspirin or a statin, and he suggested that FAI might be a way to better target an anti-inflammatory agent such as canakinumab (Ilaris), which showed cardiovascular protective effects in the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31).
Another key feature of the FAI analysis is that it uses data collected by “any standard” coronary CT angiogram, Dr. Antoniades said. He is a founder of, shareholder in, and chief scientific officer of Caristo Diagnostics, the company developing the software that uses coronary CT data to calculate the FAI.
Dr. Antoniades and his associates derived the FAI using data collected from 1,872 patients who underwent planned coronary CT angiography at a clinic in Erlangen, Germany, during 2005-2009. The researchers correlated FAI scores with cardiovascular disease outcomes during a median follow-up of 72 months. They then validated the FAI using data collected from 2,040 patients who underwent a planned coronary CT exam at the Cleveland Clinic during 2008-2016 and then had a median follow-up of 54 months. The researchers called this overall post-hoc analysis of prospectively collected CT and outcomes data the Cardiovascular Risk Prediction using Computed Tomography (CRISP-CT) study.
Using the derivation data, FAI measurements taken from fat around the proximal right coronary artery that met or exceeded the specified cutoff value of –70.1 Hounsfield units were tied to a 9.04-fold greater rate of cardiac death during follow-up, compared with patients with a lower FAI, and after adjustment for several demographic, clinical, and CT-angiography variables. When the researchers ran this analysis using data from the validation patients and the same cutoff value they found that an elevated FAI linked with a 5.6-fold higher rate of cardiac death. Concurrently with Dr. Antoniades’ talk the results appeared in an online article that was later published (Lancet. 2018 Sep 15;392[10151]:929-39).
Calculating a patient’s FAI offers the prospect for “better use of CT information,” Dr. Antoniades said during the discussion of his report. After a coronary CT scan and conventional data processing, about half the patients have no finding that warrants intervention, but about 10% of these patients actually have an inflamed coronary plaque that is at high risk for rupture that could trigger a cardiac event. The FAI provides a way to use coronary CT angiography to identify these at-risk patients, he explained.
MUNICH – The perivascular fat attenuation index, a new measure of coronary plaque inflammation using data collected by a conventional coronary CT scan, identified an elevated risk for future cardiovascular death that was independent of standard risk factors in both derivation and validation studies with prospective data from more than 3,900 patients.
Patients with a high fat attenuation index (FAI) in the perivascular fat surrounding their right coronary artery had a five- to ninefold higher risk of cardiac mortality during 4-6 years of follow-up than did those with lower scores, after adjustment for conventional risk factors and standard findings from the coronary CT, Charalambos Antoniades, MD, said at the annual congress of the European Society of Cardiology.
The FAI is a “powerful, novel technology for cardiovascular disease risk stratification. It has striking prognostic value for cardiac death and nonfatal MI over and above other risk scores and state-of-the-art interpretation of coronary CT angiography,” said Dr. Antoniades, professor of cardiovascular medicine at the University of Oxford (England). He also highlighted that the data he reported suggested a protective effect in patients with a high FAI who received treatment with aspirin or a statin, and he suggested that FAI might be a way to better target an anti-inflammatory agent such as canakinumab (Ilaris), which showed cardiovascular protective effects in the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31).
Another key feature of the FAI analysis is that it uses data collected by “any standard” coronary CT angiogram, Dr. Antoniades said. He is a founder of, shareholder in, and chief scientific officer of Caristo Diagnostics, the company developing the software that uses coronary CT data to calculate the FAI.
Dr. Antoniades and his associates derived the FAI using data collected from 1,872 patients who underwent planned coronary CT angiography at a clinic in Erlangen, Germany, during 2005-2009. The researchers correlated FAI scores with cardiovascular disease outcomes during a median follow-up of 72 months. They then validated the FAI using data collected from 2,040 patients who underwent a planned coronary CT exam at the Cleveland Clinic during 2008-2016 and then had a median follow-up of 54 months. The researchers called this overall post-hoc analysis of prospectively collected CT and outcomes data the Cardiovascular Risk Prediction using Computed Tomography (CRISP-CT) study.
Using the derivation data, FAI measurements taken from fat around the proximal right coronary artery that met or exceeded the specified cutoff value of –70.1 Hounsfield units were tied to a 9.04-fold greater rate of cardiac death during follow-up, compared with patients with a lower FAI, and after adjustment for several demographic, clinical, and CT-angiography variables. When the researchers ran this analysis using data from the validation patients and the same cutoff value they found that an elevated FAI linked with a 5.6-fold higher rate of cardiac death. Concurrently with Dr. Antoniades’ talk the results appeared in an online article that was later published (Lancet. 2018 Sep 15;392[10151]:929-39).
Calculating a patient’s FAI offers the prospect for “better use of CT information,” Dr. Antoniades said during the discussion of his report. After a coronary CT scan and conventional data processing, about half the patients have no finding that warrants intervention, but about 10% of these patients actually have an inflamed coronary plaque that is at high risk for rupture that could trigger a cardiac event. The FAI provides a way to use coronary CT angiography to identify these at-risk patients, he explained.
MUNICH – The perivascular fat attenuation index, a new measure of coronary plaque inflammation using data collected by a conventional coronary CT scan, identified an elevated risk for future cardiovascular death that was independent of standard risk factors in both derivation and validation studies with prospective data from more than 3,900 patients.
Patients with a high fat attenuation index (FAI) in the perivascular fat surrounding their right coronary artery had a five- to ninefold higher risk of cardiac mortality during 4-6 years of follow-up than did those with lower scores, after adjustment for conventional risk factors and standard findings from the coronary CT, Charalambos Antoniades, MD, said at the annual congress of the European Society of Cardiology.
The FAI is a “powerful, novel technology for cardiovascular disease risk stratification. It has striking prognostic value for cardiac death and nonfatal MI over and above other risk scores and state-of-the-art interpretation of coronary CT angiography,” said Dr. Antoniades, professor of cardiovascular medicine at the University of Oxford (England). He also highlighted that the data he reported suggested a protective effect in patients with a high FAI who received treatment with aspirin or a statin, and he suggested that FAI might be a way to better target an anti-inflammatory agent such as canakinumab (Ilaris), which showed cardiovascular protective effects in the CANTOS trial (N Engl J Med. 2017 Sep 21;377[12]:1119-31).
Another key feature of the FAI analysis is that it uses data collected by “any standard” coronary CT angiogram, Dr. Antoniades said. He is a founder of, shareholder in, and chief scientific officer of Caristo Diagnostics, the company developing the software that uses coronary CT data to calculate the FAI.
Dr. Antoniades and his associates derived the FAI using data collected from 1,872 patients who underwent planned coronary CT angiography at a clinic in Erlangen, Germany, during 2005-2009. The researchers correlated FAI scores with cardiovascular disease outcomes during a median follow-up of 72 months. They then validated the FAI using data collected from 2,040 patients who underwent a planned coronary CT exam at the Cleveland Clinic during 2008-2016 and then had a median follow-up of 54 months. The researchers called this overall post-hoc analysis of prospectively collected CT and outcomes data the Cardiovascular Risk Prediction using Computed Tomography (CRISP-CT) study.
Using the derivation data, FAI measurements taken from fat around the proximal right coronary artery that met or exceeded the specified cutoff value of –70.1 Hounsfield units were tied to a 9.04-fold greater rate of cardiac death during follow-up, compared with patients with a lower FAI, and after adjustment for several demographic, clinical, and CT-angiography variables. When the researchers ran this analysis using data from the validation patients and the same cutoff value they found that an elevated FAI linked with a 5.6-fold higher rate of cardiac death. Concurrently with Dr. Antoniades’ talk the results appeared in an online article that was later published (Lancet. 2018 Sep 15;392[10151]:929-39).
Calculating a patient’s FAI offers the prospect for “better use of CT information,” Dr. Antoniades said during the discussion of his report. After a coronary CT scan and conventional data processing, about half the patients have no finding that warrants intervention, but about 10% of these patients actually have an inflamed coronary plaque that is at high risk for rupture that could trigger a cardiac event. The FAI provides a way to use coronary CT angiography to identify these at-risk patients, he explained.
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point:
Major finding: Patients with a fat attenuation index at or above the selected cutoff had a five- to ninefold increased rate of cardiac death.
Study details: The CRISP-CT study, which ran a post-hoc analysis of CT angiography data from 3,912 patients.
Disclosures: Dr. Antoniades is a founder of, shareholder in, and chief scientific officer of Caristo Diagnostics, the company developing fat attenuation index software.
Protocol violations, missed transfusions among blood delivery errors
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
BOSTON – Even the most vigilant hospitals experience problems with blood storage and delivery on the patient floor, particularly in pediatric units, investigators cautioned.
A review of patient safety incidents that occurred surrounding more than 1 million transfusions in U.S. hospitals showed that pediatric transfusions were associated with a higher rate of safety problems compared with adult transfusions, with errors differing by age group.
“We just looked at units transfused [and] incidents that occurred during product administration and we found that the highest incident in the pediatric population is that the protocol is not being followed, and the highest incident in the adult population is that the transfusion is not performed, in error, at all,” said Sarah Vossoughi, MD, of Columbia University and New York–Presbyterian Hospital, New York.
In both settings, the investigators observed problems with product storage on the patient floor. “It’s very common for blood banks to find platelets in the refrigerator. It doesn’t matter how old you are or what type of hospital you’re at – everyone’s putting platelets in the fridge,” she said in an interview at AABB 2018, the annual meeting of the organization formerly known as the American Association of Blood Banks.
Dr. Vossoughi and her colleagues in New York and at the University of Vermont in Burlington noted that the National Patient Safety Foundation, now a part of the Institute for Healthcare Improvement, declared preventable medical harm to be a public health crisis. In a paper published in the BMJ in 2016, researchers estimated that medical errors were the third leading cause of death in the United States, accounting for more than 250,000 fatalities annually.
Dr. Vossoughi also pointed to a study suggesting that the incidence of nonlethal medical errors may be 10- to 20-fold higher than the number of fatal errors (J Patient Saf. 2013 Sep;9[3]:122-8).
To evaluate patient safety events related to blood transfusions, Dr. Vossoughi and her colleagues drew data on events reported by three children’s hospitals and 29 adult hospitals to either the AABB Center for Patient Safety or the medical center’s own adverse event reporting system from January 2010 through September 2017.
They identified a total of 1,806 reports associated with approximately 1,088.884 transfusions. Of these reports, 249 were associated with 99,064 pediatric transfusions, and 1,577 were reported in association with 989,820 adult transfusions.
In all, 31% of the pediatric events were failure to follow the transfusion protocol.
“In a lot of the pediatric hospitals, it’s kind of like the Wild West. People say, ‘well I know it’s the hospital policy, but this child is special, so I’m going to do it this way, this time.’ That seems to be a culture in pediatrics, whereas on the adult side [clinicians] seem to be much less likely to just deviate from the protocol,” Dr. Vossoughi said.
Among adults, 43% of the errors were “transfusion not performed,” which may occur because of a bungled patient hand-off during a shift change, or when a patient is being moved from one unit to another.
“The next day, they’ll check the patient’s CBC and realize that the patient didn’t respond to the infusion that it turned out they never got, and then the product will be found on the floor, expired,” Dr. Vossoughi said.
In all, 20% of pediatric errors and 24% of adult errors were associated with incorrect storage of blood products on the patient floor.
The information they presented could help inpatient blood management programs target education and interventions to providers who commit similar errors.
“If you know that a particular provider group has problems following the protocol, maybe you can make the protocol a little simpler to follow, or make the checklist less cumbersome, and then maybe they’ll follow them more often,” she said.
The study was supported by the AABB Center for Patient Safety and University of Vermont Medical Center. The authors reported no conflicts of interest.
SOURCE: Vossoughi S et al. AABB 2018, Abstract QT4.
REPORTING FROM AABB 2018
Key clinical point:
Major finding: In all, 31% of pediatric errors were due to protocol violation, and 43% of adult errors were due to an ordered transfusion not being performed.
Study details: Descriptive study of data from 32 U.S. hospitals that reported transfusion safety events.
Disclosures: The study was supported by the AABB Center for Patient Safety and University of Vermont. The authors reported no conflicts of interest.
Source: Vossoughi S et al. AABB 2018, Abstract QT4.
Talazoparib approved for HER2-negative advanced breast cancer
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.
The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.