SAN DIEGO – Vedolizumab, a novel drug that selectively blocks lymphocyte trafficking to the gut, was safe and highly effective for inducing and maintaining clinical remission in patients with moderate to severe ulcerative colitis in a pivotal phase III trial.

"If the findings hold up with more detailed analysis, it looks like we’ll have the efficacy of a biologic agent without some of the toxicity issues that we’ve seen with anti-TNF [tumor necrosis factor] drugs," said Dr. William J. Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego.

"This potentially could be a first-line drug," for treating moderate to severe ulcerative colitis, said Dr. Sandborn, a coinvestigator in the study.

"Vedolizumab was more effective than placebo for induction and maintenance treatment, including both anti-TNF–exposed and naive patients," Dr. Brian G. Feagan, the study’s lead investigator, said at the annual Digestive Disease Week. In addition, there was little difference between the vedolizumab and placebo groups in terms of adverse events, serious adverse events, and serious infections, said Dr. Feagan, professor of medicine at Western University in London, Ont.

At the end of a year of maintenance treatment, patients kept on the more frequent vedolizumab dosage tested, 300 mg delivered intravenously once every 4 weeks, showed a potent efficacy effect, surpassing the placebo group in corticosteroid-free clinical remissions by 31 percentage points (45% vs. 14%). "Nothing else is that good," Dr. Sandborn said in an interview. "Steroid-free remission with a delta over placebo of 30% is very impressive, especially when you factor in that many of the patients had failed anti-TNF treatment.

"We thought that vedolizumab would be safer than systemic immunosuppression, and I think the data are consistent with that. This will be a first-line treatment," Dr. Feagan said.

Equally important, total worldwide experience with vedolizumab, which now includes about 2,500 patients, has not yet resulted in a single case of progressive multifocal leukoencephalopathy (PML), an adverse effect produced by vedolizumab’s cousin drug, natalizumab (Tysarbi), ’approved for U.S. marketing to treat multiple sclerosis and Crohns disease.

Vedolizumab is a humanized monoclonal antibody that specifically binds to the alpha-4 beta-7 integrin protein that helps move leukocytes into the gut. Natalizumab is a less specific integrin antagonist that affects the protein’s actions and immune-cell trafficking to a variety of body sites, including the brain. Natalizumab "essentially blocks immune surveillance in the brain, and that allows for the JC virus [carried by about 50% of people] to cause PML," explained Dr. Sandborn. In contrast, vedolizumab does not cause "a systemic blockade of lymphocytes trafficking; it only affects a small fraction of lymphocytes, and leaves the brain completely unaffected."

Patients most at risk for PML are those who previously received immunosuppressive treatment with a drug such as azathioprine, methotrexate, or an anti-TNF drug. Patients with that history who received natalizumab for 1-2 years have about a 1 in 500-600 risk for PML, and those who got natalizumab for more than 2 years have a 1% risk.

By comparison, vedolizomab’s clean record based on 2,500 recipients "looks like it might have a very nice safety profile. If people can get comfortable with vedolizumab being different from natalizumab, then it has the potential to be first-line therapy for patients who have the worst prognosis," those who don’t respond to treatment with mesalamine.

The GEMINI I trial enrolled patients at 105 international sites with ulcerative colitis who had a Mayo score of at least 6 and an endoscopic subscore of at least 2 (indicating moderate disease) despite standard treatments. Patients were an average age of 40 years, their average duration of disease was 7 years, and their average Mayo score at entry was 8.5. Roughly 40% had previously received an anti-TNF treatment, about a third had failed on an anti-TNF drug, and just over half of the patients entered the study on a corticosteroid.

The trial included an induction phase that randomized 225 patients to a 6-week regimen with vedolizumab infusions and 149 patients to placebo. The researchers started another 521 ulcerative colitis patients on an open-label induction regimen, and then randomized 373 patients who responded after 6 weeks to maintenance infusion with vedolizumab every 4 weeks, a vedolizumab infusion every 8 weeks, or placebo.

The primary end point of the induction phase was clinical response, defined as a drop in the Mayo score of at least 3 points and at least 30%, plus a drop in the rectal bleeding score of at least 1 point or an absolute rectal bleeding subscore of 1 point or less. Achievement of this end point occurred in 47% of patients on vedolizumab and in 26% of those on placebo, a statistically significant difference. Among patients previously treated with an anti-TNF drug, 39% had a clinical response after 6 weeks on vedolizumab compared with 21% in the placebo arm, a significant difference. Among anti-TNF–naive patients, the rates were 53% and 26%.

The primary end point of the maintenance phase was clinical remission at 52 weeks, defined as a total Mayo score of 2 or less and no subscore greater than 1 point. This end point was met by 45% of patients who received vedolizumab every 4 weeks, by 42% who received the drug every 8 weeks, and by 16% of the placebo patients. Clinical remission without corticosteroid treatment occurred in 45% of patients who got vedolizumab every 4 weeks, 31% who got the drug every 8 weeks, and 14% who took placebo. Among patients with a history of anti-TNF treatment, clinical remission after 1 year occurred in 35% of patients maintained with the drug every 4 weeks, 37% who got the drug every 8 weeks, and 5% who took placebo. A total of 209 patients remained in the study through the 52-week assessment.

On May 11, Millennium Pharmaceuticals, the company developing vedolizumab, announced that the drug significantly surpassed placebo for the treatment of Crohn’s disease in the pivotal, phase III trial for that indication. The company said that it will soon report the full Crohn’s disease results.

The GEMINI I study was funded by Millennium. Dr. Feagan said he has been a consultant to Millennium and to several other drug companies. Dr. Sandborn said he has been a consultant to several drug companies but has no relationship with Millennium.

SAN DIEGO – Vedolizumab, a novel drug that selectively blocks lymphocyte trafficking to the gut, was safe and highly effective for inducing and maintaining clinical remission in patients with moderate to severe ulcerative colitis in a pivotal phase III trial.

"If the findings hold up with more detailed analysis, it looks like we’ll have the efficacy of a biologic agent without some of the toxicity issues that we’ve seen with anti-TNF [tumor necrosis factor] drugs," said Dr. William J. Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego.

"This potentially could be a first-line drug," for treating moderate to severe ulcerative colitis, said Dr. Sandborn, a coinvestigator in the study.

"Vedolizumab was more effective than placebo for induction and maintenance treatment, including both anti-TNF–exposed and naive patients," Dr. Brian G. Feagan, the study’s lead investigator, said at the annual Digestive Disease Week. In addition, there was little difference between the vedolizumab and placebo groups in terms of adverse events, serious adverse events, and serious infections, said Dr. Feagan, professor of medicine at Western University in London, Ont.

At the end of a year of maintenance treatment, patients kept on the more frequent vedolizumab dosage tested, 300 mg delivered intravenously once every 4 weeks, showed a potent efficacy effect, surpassing the placebo group in corticosteroid-free clinical remissions by 31 percentage points (45% vs. 14%). "Nothing else is that good," Dr. Sandborn said in an interview. "Steroid-free remission with a delta over placebo of 30% is very impressive, especially when you factor in that many of the patients had failed anti-TNF treatment.

"We thought that vedolizumab would be safer than systemic immunosuppression, and I think the data are consistent with that. This will be a first-line treatment," Dr. Feagan said.

Equally important, total worldwide experience with vedolizumab, which now includes about 2,500 patients, has not yet resulted in a single case of progressive multifocal leukoencephalopathy (PML), an adverse effect produced by vedolizumab’s cousin drug, natalizumab (Tysarbi), ’approved for U.S. marketing to treat multiple sclerosis and Crohns disease.

Vedolizumab is a humanized monoclonal antibody that specifically binds to the alpha-4 beta-7 integrin protein that helps move leukocytes into the gut. Natalizumab is a less specific integrin antagonist that affects the protein’s actions and immune-cell trafficking to a variety of body sites, including the brain. Natalizumab "essentially blocks immune surveillance in the brain, and that allows for the JC virus [carried by about 50% of people] to cause PML," explained Dr. Sandborn. In contrast, vedolizumab does not cause "a systemic blockade of lymphocytes trafficking; it only affects a small fraction of lymphocytes, and leaves the brain completely unaffected."

Patients most at risk for PML are those who previously received immunosuppressive treatment with a drug such as azathioprine, methotrexate, or an anti-TNF drug. Patients with that history who received natalizumab for 1-2 years have about a 1 in 500-600 risk for PML, and those who got natalizumab for more than 2 years have a 1% risk.

By comparison, vedolizomab’s clean record based on 2,500 recipients "looks like it might have a very nice safety profile. If people can get comfortable with vedolizumab being different from natalizumab, then it has the potential to be first-line therapy for patients who have the worst prognosis," those who don’t respond to treatment with mesalamine.

The GEMINI I trial enrolled patients at 105 international sites with ulcerative colitis who had a Mayo score of at least 6 and an endoscopic subscore of at least 2 (indicating moderate disease) despite standard treatments. Patients were an average age of 40 years, their average duration of disease was 7 years, and their average Mayo score at entry was 8.5. Roughly 40% had previously received an anti-TNF treatment, about a third had failed on an anti-TNF drug, and just over half of the patients entered the study on a corticosteroid.

The trial included an induction phase that randomized 225 patients to a 6-week regimen with vedolizumab infusions and 149 patients to placebo. The researchers started another 521 ulcerative colitis patients on an open-label induction regimen, and then randomized 373 patients who responded after 6 weeks to maintenance infusion with vedolizumab every 4 weeks, a vedolizumab infusion every 8 weeks, or placebo.

The primary end point of the induction phase was clinical response, defined as a drop in the Mayo score of at least 3 points and at least 30%, plus a drop in the rectal bleeding score of at least 1 point or an absolute rectal bleeding subscore of 1 point or less. Achievement of this end point occurred in 47% of patients on vedolizumab and in 26% of those on placebo, a statistically significant difference. Among patients previously treated with an anti-TNF drug, 39% had a clinical response after 6 weeks on vedolizumab compared with 21% in the placebo arm, a significant difference. Among anti-TNF–naive patients, the rates were 53% and 26%.

The primary end point of the maintenance phase was clinical remission at 52 weeks, defined as a total Mayo score of 2 or less and no subscore greater than 1 point. This end point was met by 45% of patients who received vedolizumab every 4 weeks, by 42% who received the drug every 8 weeks, and by 16% of the placebo patients. Clinical remission without corticosteroid treatment occurred in 45% of patients who got vedolizumab every 4 weeks, 31% who got the drug every 8 weeks, and 14% who took placebo. Among patients with a history of anti-TNF treatment, clinical remission after 1 year occurred in 35% of patients maintained with the drug every 4 weeks, 37% who got the drug every 8 weeks, and 5% who took placebo. A total of 209 patients remained in the study through the 52-week assessment.

On May 11, Millennium Pharmaceuticals, the company developing vedolizumab, announced that the drug significantly surpassed placebo for the treatment of Crohn’s disease in the pivotal, phase III trial for that indication. The company said that it will soon report the full Crohn’s disease results.

The GEMINI I study was funded by Millennium. Dr. Feagan said he has been a consultant to Millennium and to several other drug companies. Dr. Sandborn said he has been a consultant to several drug companies but has no relationship with Millennium.

SAN DIEGO – Vedolizumab, a novel drug that selectively blocks lymphocyte trafficking to the gut, was safe and highly effective for inducing and maintaining clinical remission in patients with moderate to severe ulcerative colitis in a pivotal phase III trial.

"If the findings hold up with more detailed analysis, it looks like we’ll have the efficacy of a biologic agent without some of the toxicity issues that we’ve seen with anti-TNF [tumor necrosis factor] drugs," said Dr. William J. Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego.

"This potentially could be a first-line drug," for treating moderate to severe ulcerative colitis, said Dr. Sandborn, a coinvestigator in the study.

"Vedolizumab was more effective than placebo for induction and maintenance treatment, including both anti-TNF–exposed and naive patients," Dr. Brian G. Feagan, the study’s lead investigator, said at the annual Digestive Disease Week. In addition, there was little difference between the vedolizumab and placebo groups in terms of adverse events, serious adverse events, and serious infections, said Dr. Feagan, professor of medicine at Western University in London, Ont.

At the end of a year of maintenance treatment, patients kept on the more frequent vedolizumab dosage tested, 300 mg delivered intravenously once every 4 weeks, showed a potent efficacy effect, surpassing the placebo group in corticosteroid-free clinical remissions by 31 percentage points (45% vs. 14%). "Nothing else is that good," Dr. Sandborn said in an interview. "Steroid-free remission with a delta over placebo of 30% is very impressive, especially when you factor in that many of the patients had failed anti-TNF treatment.

"We thought that vedolizumab would be safer than systemic immunosuppression, and I think the data are consistent with that. This will be a first-line treatment," Dr. Feagan said.

Equally important, total worldwide experience with vedolizumab, which now includes about 2,500 patients, has not yet resulted in a single case of progressive multifocal leukoencephalopathy (PML), an adverse effect produced by vedolizumab’s cousin drug, natalizumab (Tysarbi), ’approved for U.S. marketing to treat multiple sclerosis and Crohns disease.

Vedolizumab is a humanized monoclonal antibody that specifically binds to the alpha-4 beta-7 integrin protein that helps move leukocytes into the gut. Natalizumab is a less specific integrin antagonist that affects the protein’s actions and immune-cell trafficking to a variety of body sites, including the brain. Natalizumab "essentially blocks immune surveillance in the brain, and that allows for the JC virus [carried by about 50% of people] to cause PML," explained Dr. Sandborn. In contrast, vedolizumab does not cause "a systemic blockade of lymphocytes trafficking; it only affects a small fraction of lymphocytes, and leaves the brain completely unaffected."

Patients most at risk for PML are those who previously received immunosuppressive treatment with a drug such as azathioprine, methotrexate, or an anti-TNF drug. Patients with that history who received natalizumab for 1-2 years have about a 1 in 500-600 risk for PML, and those who got natalizumab for more than 2 years have a 1% risk.

By comparison, vedolizomab’s clean record based on 2,500 recipients "looks like it might have a very nice safety profile. If people can get comfortable with vedolizumab being different from natalizumab, then it has the potential to be first-line therapy for patients who have the worst prognosis," those who don’t respond to treatment with mesalamine.

The GEMINI I trial enrolled patients at 105 international sites with ulcerative colitis who had a Mayo score of at least 6 and an endoscopic subscore of at least 2 (indicating moderate disease) despite standard treatments. Patients were an average age of 40 years, their average duration of disease was 7 years, and their average Mayo score at entry was 8.5. Roughly 40% had previously received an anti-TNF treatment, about a third had failed on an anti-TNF drug, and just over half of the patients entered the study on a corticosteroid.

The trial included an induction phase that randomized 225 patients to a 6-week regimen with vedolizumab infusions and 149 patients to placebo. The researchers started another 521 ulcerative colitis patients on an open-label induction regimen, and then randomized 373 patients who responded after 6 weeks to maintenance infusion with vedolizumab every 4 weeks, a vedolizumab infusion every 8 weeks, or placebo.

The primary end point of the induction phase was clinical response, defined as a drop in the Mayo score of at least 3 points and at least 30%, plus a drop in the rectal bleeding score of at least 1 point or an absolute rectal bleeding subscore of 1 point or less. Achievement of this end point occurred in 47% of patients on vedolizumab and in 26% of those on placebo, a statistically significant difference. Among patients previously treated with an anti-TNF drug, 39% had a clinical response after 6 weeks on vedolizumab compared with 21% in the placebo arm, a significant difference. Among anti-TNF–naive patients, the rates were 53% and 26%.

The primary end point of the maintenance phase was clinical remission at 52 weeks, defined as a total Mayo score of 2 or less and no subscore greater than 1 point. This end point was met by 45% of patients who received vedolizumab every 4 weeks, by 42% who received the drug every 8 weeks, and by 16% of the placebo patients. Clinical remission without corticosteroid treatment occurred in 45% of patients who got vedolizumab every 4 weeks, 31% who got the drug every 8 weeks, and 14% who took placebo. Among patients with a history of anti-TNF treatment, clinical remission after 1 year occurred in 35% of patients maintained with the drug every 4 weeks, 37% who got the drug every 8 weeks, and 5% who took placebo. A total of 209 patients remained in the study through the 52-week assessment.

On May 11, Millennium Pharmaceuticals, the company developing vedolizumab, announced that the drug significantly surpassed placebo for the treatment of Crohn’s disease in the pivotal, phase III trial for that indication. The company said that it will soon report the full Crohn’s disease results.

The GEMINI I study was funded by Millennium. Dr. Feagan said he has been a consultant to Millennium and to several other drug companies. Dr. Sandborn said he has been a consultant to several drug companies but has no relationship with Millennium.

Creating a sanctioned pathway to turn hospitalists into intensivists can help fill the growing shortage of trained physicians in ICUs, according to a new position paper from SHM and the Society of Critical Care Medicine.

"Training a Hospitalist Workforce to Address the Intensivist Shortage in American Hospitals," published online in the Journal of Hospital Medicine, suggests that if 5% of the projected hospitalist workforce were to complete a critical-care certification pathway created by the Accreditation Council for Graduate Medical Education (ACGME), 2,500 new intensivists could enter hospitals in the coming years.

"The ICU is in crisis because of the workforce shortage," says Mary Jo Gorman, MD, MBA, MHM, CEO of St. Louis-based Advanced ICU Care and former SHM president. "It's only going to get worse. [Hospitalists] need to be strategically trying to figure out how they are going to solve this problem. This is one of the calls for action that we think can really help the problem across the country. It won't be 100% of the solution, but we think it can contribute to the solution."

Lead author Eric Siegal, MD, SFHM, director of critical care medicine at Aurora St Luke's Medical Center in Milwaukee and a SHM board member, says it may take years to craft a formal pathway to accredit HM physicians in critical care, but the task is important as hospitalists already are being pressed into duty as intensivists.

"The real question is, how do we ensure that the hospitalists who are in those hospitals are qualified to handle the work that they already perform?" he says. "Hospitalists are de facto intensivists in many ICUs, whether they are qualified to do so or not ... so this seems like a logical evolution of HM."

Creating a sanctioned pathway to turn hospitalists into intensivists can help fill the growing shortage of trained physicians in ICUs, according to a new position paper from SHM and the Society of Critical Care Medicine.

"Training a Hospitalist Workforce to Address the Intensivist Shortage in American Hospitals," published online in the Journal of Hospital Medicine, suggests that if 5% of the projected hospitalist workforce were to complete a critical-care certification pathway created by the Accreditation Council for Graduate Medical Education (ACGME), 2,500 new intensivists could enter hospitals in the coming years.

"The ICU is in crisis because of the workforce shortage," says Mary Jo Gorman, MD, MBA, MHM, CEO of St. Louis-based Advanced ICU Care and former SHM president. "It's only going to get worse. [Hospitalists] need to be strategically trying to figure out how they are going to solve this problem. This is one of the calls for action that we think can really help the problem across the country. It won't be 100% of the solution, but we think it can contribute to the solution."

Lead author Eric Siegal, MD, SFHM, director of critical care medicine at Aurora St Luke's Medical Center in Milwaukee and a SHM board member, says it may take years to craft a formal pathway to accredit HM physicians in critical care, but the task is important as hospitalists already are being pressed into duty as intensivists.

"The real question is, how do we ensure that the hospitalists who are in those hospitals are qualified to handle the work that they already perform?" he says. "Hospitalists are de facto intensivists in many ICUs, whether they are qualified to do so or not ... so this seems like a logical evolution of HM."

Creating a sanctioned pathway to turn hospitalists into intensivists can help fill the growing shortage of trained physicians in ICUs, according to a new position paper from SHM and the Society of Critical Care Medicine.

"Training a Hospitalist Workforce to Address the Intensivist Shortage in American Hospitals," published online in the Journal of Hospital Medicine, suggests that if 5% of the projected hospitalist workforce were to complete a critical-care certification pathway created by the Accreditation Council for Graduate Medical Education (ACGME), 2,500 new intensivists could enter hospitals in the coming years.

"The ICU is in crisis because of the workforce shortage," says Mary Jo Gorman, MD, MBA, MHM, CEO of St. Louis-based Advanced ICU Care and former SHM president. "It's only going to get worse. [Hospitalists] need to be strategically trying to figure out how they are going to solve this problem. This is one of the calls for action that we think can really help the problem across the country. It won't be 100% of the solution, but we think it can contribute to the solution."

Lead author Eric Siegal, MD, SFHM, director of critical care medicine at Aurora St Luke's Medical Center in Milwaukee and a SHM board member, says it may take years to craft a formal pathway to accredit HM physicians in critical care, but the task is important as hospitalists already are being pressed into duty as intensivists.

"The real question is, how do we ensure that the hospitalists who are in those hospitals are qualified to handle the work that they already perform?" he says. "Hospitalists are de facto intensivists in many ICUs, whether they are qualified to do so or not ... so this seems like a logical evolution of HM."

Clinical question: What are the current job satisfaction levels of hospitalists?

Background: The number of hospitalists is growing rapidly, and there are now estimated to be 30,000 hospitalists in the U.S. Despite this rapid growth, little is known about whether being a hospitalist is a viable long-term career choice or if hospitalists are prone to burnout. This study sought to examine the job satisfaction levels of hospitalists and assess their risk of burnout.

Study design: Survey.

Setting: A representative, stratified sample of practicing hospitalists who were members of SHM or had attended an SHM event were surveyed using the Hospital Medicine Physician Work-Life Survey, an instrument developed by SHM’s Career Satisfaction Task Force. The survey measured 22 domains, including general job and specialty satisfaction, specific satisfaction domains (e.g. compensation, workload, personal time), stress, burnout, and intent to leave.

Synopsis: A total of 816 hospitalists responded to the survey for a response rate of 26%. Nearly 63% of respondents reported high overall job satisfaction and 69% reported high satisfaction with hospital medicine as a specialty. The majority of respondents reported high satisfaction with care quality (82.3%), relationships with staff (79.5%), colleagues (76.2%), and their leaders (75.4%). A minority of respondents reported satisfaction with organizational fairness (31.2%), personal time (28.3%), compensation (27.9%), and autonomy (17.4%).

Burnout symptoms were reported by 29.9% of hospitalists. Among the respondents who reported burnout symptoms, many reported that they were “very likely” (24.6%) or “somewhat likely” (20.8%) to leave their current practice within two years.

The response rate was low and might not accurately reflect the opinion of non-SHM members.

Bottom line: Most hospitalists reported high satisfaction with their job and with the specialty of hospital medicine, but a significant minority reported burnout symptoms and a likelihood of leaving their current practice.

Citation: Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 27:28-36.

Clinical question: What are the current job satisfaction levels of hospitalists?

Background: The number of hospitalists is growing rapidly, and there are now estimated to be 30,000 hospitalists in the U.S. Despite this rapid growth, little is known about whether being a hospitalist is a viable long-term career choice or if hospitalists are prone to burnout. This study sought to examine the job satisfaction levels of hospitalists and assess their risk of burnout.

Study design: Survey.

Setting: A representative, stratified sample of practicing hospitalists who were members of SHM or had attended an SHM event were surveyed using the Hospital Medicine Physician Work-Life Survey, an instrument developed by SHM’s Career Satisfaction Task Force. The survey measured 22 domains, including general job and specialty satisfaction, specific satisfaction domains (e.g. compensation, workload, personal time), stress, burnout, and intent to leave.

Synopsis: A total of 816 hospitalists responded to the survey for a response rate of 26%. Nearly 63% of respondents reported high overall job satisfaction and 69% reported high satisfaction with hospital medicine as a specialty. The majority of respondents reported high satisfaction with care quality (82.3%), relationships with staff (79.5%), colleagues (76.2%), and their leaders (75.4%). A minority of respondents reported satisfaction with organizational fairness (31.2%), personal time (28.3%), compensation (27.9%), and autonomy (17.4%).

Burnout symptoms were reported by 29.9% of hospitalists. Among the respondents who reported burnout symptoms, many reported that they were “very likely” (24.6%) or “somewhat likely” (20.8%) to leave their current practice within two years.

The response rate was low and might not accurately reflect the opinion of non-SHM members.

Bottom line: Most hospitalists reported high satisfaction with their job and with the specialty of hospital medicine, but a significant minority reported burnout symptoms and a likelihood of leaving their current practice.

Citation: Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 27:28-36.

Clinical question: What are the current job satisfaction levels of hospitalists?

Background: The number of hospitalists is growing rapidly, and there are now estimated to be 30,000 hospitalists in the U.S. Despite this rapid growth, little is known about whether being a hospitalist is a viable long-term career choice or if hospitalists are prone to burnout. This study sought to examine the job satisfaction levels of hospitalists and assess their risk of burnout.

Study design: Survey.

Setting: A representative, stratified sample of practicing hospitalists who were members of SHM or had attended an SHM event were surveyed using the Hospital Medicine Physician Work-Life Survey, an instrument developed by SHM’s Career Satisfaction Task Force. The survey measured 22 domains, including general job and specialty satisfaction, specific satisfaction domains (e.g. compensation, workload, personal time), stress, burnout, and intent to leave.

Synopsis: A total of 816 hospitalists responded to the survey for a response rate of 26%. Nearly 63% of respondents reported high overall job satisfaction and 69% reported high satisfaction with hospital medicine as a specialty. The majority of respondents reported high satisfaction with care quality (82.3%), relationships with staff (79.5%), colleagues (76.2%), and their leaders (75.4%). A minority of respondents reported satisfaction with organizational fairness (31.2%), personal time (28.3%), compensation (27.9%), and autonomy (17.4%).

Burnout symptoms were reported by 29.9% of hospitalists. Among the respondents who reported burnout symptoms, many reported that they were “very likely” (24.6%) or “somewhat likely” (20.8%) to leave their current practice within two years.

The response rate was low and might not accurately reflect the opinion of non-SHM members.

Bottom line: Most hospitalists reported high satisfaction with their job and with the specialty of hospital medicine, but a significant minority reported burnout symptoms and a likelihood of leaving their current practice.

Citation: Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck TB. Worklife and satisfaction of hospitalists: toward flourishing careers. J Gen Intern Med. 27:28-36.

Take emergency weather warnings seriously, prepare a plan to triage and treat mass casualties, and consider how you would work in a worst-case scenario following a major natural disaster. These are some lessons learned by a thoracic surgeon who survived a devastating EF 5 tornado that ripped through his hometown of Joplin, Mo.

All normal communications were down when Dr. Michael Phillips arrived at his hospital, the Freeman Health System Heart and Vascular Institute. Staff figured out they could communicate via Facebook, Twitter, and texts.

Photos courtesy Dr. Michael Phillips

There was no water pressure or clean water. "We were on generator power only, with no ability to identify any patient and no labs or x-rays," Dr. Phillips said at the annual meeting of the American Association for Thoracic Surgery.

Nearby St. John’s Regional Medical Center, a 360-bed hospital, "was lifted off the ground and moved four inches off its foundation." There were 183 inpatients at St. John’s when the tornado touched down with winds approaching 300 mph on May 22, 2011. More than 70 patients, including 11 on ventilator support, "came to our hospital needing a place to stay, and we were already full. We have a 250 bed hospital – what do you do from there?"

More than 1,000 patients were treated in the first 24 hours. There were 11 deaths in the first six hours and "I pronounced seven of them," said Dr. Phillips, a cardiothoracic surgeon at Freeman. There were 161 deaths overall, making the Joplin tornado the deadliest on record since 1950.

"We didn’t sleep. We operated nonstop. We performed 22 operations during that time, 13 of which I performed. It was almost 30 hours before I took a break, the same thing with all the people around me," Dr. Phillips replied. "I was really blessed by having a wonderful staff around me."

"There were so many challenges to overcome; it’s really hard to put into words. You have to overcome that initial shock. The layperson doesn’t understand the devastation around them; you do. You have to get your arms around it and move on and deal with the situation at hand."

"One can never train enough for such an event. We have to try to be prepared as much as possible. Preparation should include all levels within the health system," Dr. Phillips said. "Mass triage plans are critical."

Lessons learned include taking weather warnings seriously.  "We used to blow these off and we pay attention now," Dr. Phillips said. Take shelter when a siren sounds and review your plans for worst case scenarios. All this advice applies to other natural disasters – including tsunamis, typhoons, and hurricanes, he said.

"These are all natural disasters that not only take life and create mass casualties, but they also take away our basic essentials of communications, food, clothing, and shelter."

–Damian McNamara (on Twitter @MedReporter )

Take emergency weather warnings seriously, prepare a plan to triage and treat mass casualties, and consider how you would work in a worst-case scenario following a major natural disaster. These are some lessons learned by a thoracic surgeon who survived a devastating EF 5 tornado that ripped through his hometown of Joplin, Mo.

All normal communications were down when Dr. Michael Phillips arrived at his hospital, the Freeman Health System Heart and Vascular Institute. Staff figured out they could communicate via Facebook, Twitter, and texts.

Photos courtesy Dr. Michael Phillips

There was no water pressure or clean water. "We were on generator power only, with no ability to identify any patient and no labs or x-rays," Dr. Phillips said at the annual meeting of the American Association for Thoracic Surgery.

Nearby St. John’s Regional Medical Center, a 360-bed hospital, "was lifted off the ground and moved four inches off its foundation." There were 183 inpatients at St. John’s when the tornado touched down with winds approaching 300 mph on May 22, 2011. More than 70 patients, including 11 on ventilator support, "came to our hospital needing a place to stay, and we were already full. We have a 250 bed hospital – what do you do from there?"

More than 1,000 patients were treated in the first 24 hours. There were 11 deaths in the first six hours and "I pronounced seven of them," said Dr. Phillips, a cardiothoracic surgeon at Freeman. There were 161 deaths overall, making the Joplin tornado the deadliest on record since 1950.

"We didn’t sleep. We operated nonstop. We performed 22 operations during that time, 13 of which I performed. It was almost 30 hours before I took a break, the same thing with all the people around me," Dr. Phillips replied. "I was really blessed by having a wonderful staff around me."

"There were so many challenges to overcome; it’s really hard to put into words. You have to overcome that initial shock. The layperson doesn’t understand the devastation around them; you do. You have to get your arms around it and move on and deal with the situation at hand."

"One can never train enough for such an event. We have to try to be prepared as much as possible. Preparation should include all levels within the health system," Dr. Phillips said. "Mass triage plans are critical."

Lessons learned include taking weather warnings seriously.  "We used to blow these off and we pay attention now," Dr. Phillips said. Take shelter when a siren sounds and review your plans for worst case scenarios. All this advice applies to other natural disasters – including tsunamis, typhoons, and hurricanes, he said.

"These are all natural disasters that not only take life and create mass casualties, but they also take away our basic essentials of communications, food, clothing, and shelter."

–Damian McNamara (on Twitter @MedReporter )

Take emergency weather warnings seriously, prepare a plan to triage and treat mass casualties, and consider how you would work in a worst-case scenario following a major natural disaster. These are some lessons learned by a thoracic surgeon who survived a devastating EF 5 tornado that ripped through his hometown of Joplin, Mo.

All normal communications were down when Dr. Michael Phillips arrived at his hospital, the Freeman Health System Heart and Vascular Institute. Staff figured out they could communicate via Facebook, Twitter, and texts.

Photos courtesy Dr. Michael Phillips

There was no water pressure or clean water. "We were on generator power only, with no ability to identify any patient and no labs or x-rays," Dr. Phillips said at the annual meeting of the American Association for Thoracic Surgery.

Nearby St. John’s Regional Medical Center, a 360-bed hospital, "was lifted off the ground and moved four inches off its foundation." There were 183 inpatients at St. John’s when the tornado touched down with winds approaching 300 mph on May 22, 2011. More than 70 patients, including 11 on ventilator support, "came to our hospital needing a place to stay, and we were already full. We have a 250 bed hospital – what do you do from there?"

More than 1,000 patients were treated in the first 24 hours. There were 11 deaths in the first six hours and "I pronounced seven of them," said Dr. Phillips, a cardiothoracic surgeon at Freeman. There were 161 deaths overall, making the Joplin tornado the deadliest on record since 1950.

"We didn’t sleep. We operated nonstop. We performed 22 operations during that time, 13 of which I performed. It was almost 30 hours before I took a break, the same thing with all the people around me," Dr. Phillips replied. "I was really blessed by having a wonderful staff around me."

"There were so many challenges to overcome; it’s really hard to put into words. You have to overcome that initial shock. The layperson doesn’t understand the devastation around them; you do. You have to get your arms around it and move on and deal with the situation at hand."

"One can never train enough for such an event. We have to try to be prepared as much as possible. Preparation should include all levels within the health system," Dr. Phillips said. "Mass triage plans are critical."

Lessons learned include taking weather warnings seriously.  "We used to blow these off and we pay attention now," Dr. Phillips said. Take shelter when a siren sounds and review your plans for worst case scenarios. All this advice applies to other natural disasters – including tsunamis, typhoons, and hurricanes, he said.

"These are all natural disasters that not only take life and create mass casualties, but they also take away our basic essentials of communications, food, clothing, and shelter."

–Damian McNamara (on Twitter @MedReporter )

Turns out there’s more to the process of deciding which studies to publish in top medical journals than simply peer review and the selections of sage editors. At the New England Journal of Medicine, editors conducted around a half-dozen informal polls in the past year to help them assess the worthiness of a particular research question, according to Editor-in-Chief Dr. Jeffrey M. Drazen.

A case in point: When considering the study "Early vs. Late Parenteral Nutrition in Critically Ill Adults," the editors knew that most ICUs in the United States don’t start parenteral nutrition for a week, and the study results supported this "late" start (New Engl. J. Med. 2011;365:506-517). So, was this a question that really needed to be answered?

Sherry Boschert/IMNG Medical Media

Rather than rely on intuition or American self-absorption, the editors used an editorial intern who worked for the journal to do an informal survey by calling ICU doctors around the world. To their surprise, they found that ICUs in Australia, New Zealand, and most of Europe start parenteral nutrition earlier than in the United States, he said in a discussion at the annual meeting of the American Thoracic Society.

"Since we have more readers outside the U.S. than in the U.S., we figured this was something that was important to publish," said Dr. Drazen, professor of medicine at Harvard University, Boston.

"I think it has a message for ICU interventions in general. Most of the things that we reasoned based on physiology – the physiology tells you that you need to provide these calories in order for the body to heal – may be wrong," he added. "It’s hard to take the kind of physiology that we’ve learned in animals and translate it clinically to humans. We really didn’t test these questions one at a time."

The journal sifts through 5,000 submissions to publish around 200 original research articles each year. "We take the job seriously," and sometimes an informal poll helps the process, he said. The parenteral nutrition study didn’t seem to be so important at first, but "it turns out that we were wrong.

"We like to make decisions based on information rather than guessing," Dr. Drazen said. "It should be the same when treating patients."

–Sherry Boschert (on Twitter @sherryboschert)

Turns out there’s more to the process of deciding which studies to publish in top medical journals than simply peer review and the selections of sage editors. At the New England Journal of Medicine, editors conducted around a half-dozen informal polls in the past year to help them assess the worthiness of a particular research question, according to Editor-in-Chief Dr. Jeffrey M. Drazen.

A case in point: When considering the study "Early vs. Late Parenteral Nutrition in Critically Ill Adults," the editors knew that most ICUs in the United States don’t start parenteral nutrition for a week, and the study results supported this "late" start (New Engl. J. Med. 2011;365:506-517). So, was this a question that really needed to be answered?

Sherry Boschert/IMNG Medical Media

Rather than rely on intuition or American self-absorption, the editors used an editorial intern who worked for the journal to do an informal survey by calling ICU doctors around the world. To their surprise, they found that ICUs in Australia, New Zealand, and most of Europe start parenteral nutrition earlier than in the United States, he said in a discussion at the annual meeting of the American Thoracic Society.

"Since we have more readers outside the U.S. than in the U.S., we figured this was something that was important to publish," said Dr. Drazen, professor of medicine at Harvard University, Boston.

"I think it has a message for ICU interventions in general. Most of the things that we reasoned based on physiology – the physiology tells you that you need to provide these calories in order for the body to heal – may be wrong," he added. "It’s hard to take the kind of physiology that we’ve learned in animals and translate it clinically to humans. We really didn’t test these questions one at a time."

The journal sifts through 5,000 submissions to publish around 200 original research articles each year. "We take the job seriously," and sometimes an informal poll helps the process, he said. The parenteral nutrition study didn’t seem to be so important at first, but "it turns out that we were wrong.

"We like to make decisions based on information rather than guessing," Dr. Drazen said. "It should be the same when treating patients."

–Sherry Boschert (on Twitter @sherryboschert)

Turns out there’s more to the process of deciding which studies to publish in top medical journals than simply peer review and the selections of sage editors. At the New England Journal of Medicine, editors conducted around a half-dozen informal polls in the past year to help them assess the worthiness of a particular research question, according to Editor-in-Chief Dr. Jeffrey M. Drazen.

A case in point: When considering the study "Early vs. Late Parenteral Nutrition in Critically Ill Adults," the editors knew that most ICUs in the United States don’t start parenteral nutrition for a week, and the study results supported this "late" start (New Engl. J. Med. 2011;365:506-517). So, was this a question that really needed to be answered?

Sherry Boschert/IMNG Medical Media

Rather than rely on intuition or American self-absorption, the editors used an editorial intern who worked for the journal to do an informal survey by calling ICU doctors around the world. To their surprise, they found that ICUs in Australia, New Zealand, and most of Europe start parenteral nutrition earlier than in the United States, he said in a discussion at the annual meeting of the American Thoracic Society.

"Since we have more readers outside the U.S. than in the U.S., we figured this was something that was important to publish," said Dr. Drazen, professor of medicine at Harvard University, Boston.

"I think it has a message for ICU interventions in general. Most of the things that we reasoned based on physiology – the physiology tells you that you need to provide these calories in order for the body to heal – may be wrong," he added. "It’s hard to take the kind of physiology that we’ve learned in animals and translate it clinically to humans. We really didn’t test these questions one at a time."

The journal sifts through 5,000 submissions to publish around 200 original research articles each year. "We take the job seriously," and sometimes an informal poll helps the process, he said. The parenteral nutrition study didn’t seem to be so important at first, but "it turns out that we were wrong.

"We like to make decisions based on information rather than guessing," Dr. Drazen said. "It should be the same when treating patients."

–Sherry Boschert (on Twitter @sherryboschert)

More than half of U.S. states (29) do not require bicycle helmets for all children, and 14 states do not have strong laws to prevent youth concussion during sports, according to a report card on injury prevention released May 22.

The report card is part of a new report on injury prevention – "The Facts Hurt: A State-By-State Injury Prevention Policy Report" – released by the Trust for America’s Health and the Robert Wood Johnson Foundation. The report was developed in partnership with leading injury-prevention experts from the Safe States Alliance and the Society for the Advancement of Violence and Injury Research.

© james boulette/iStockphoto.com

Injuries are the third leading cause of death nationally and are the leading cause of death for Americans between the ages of 1 and 44 years. Almost half of states (24) scored a 5 out of 10 or lower on the report card, which consists of 10 injury-prevention indicators. California and New York received the highest score of 9; Montana and Ohio scored the lowest with 2.

"Overall, we need to redouble our efforts to make safety research and policy a national priority. There’s compelling evidence that we should adopt, implement, and enforce any existing policies and programs to help spare millions of Americans from needless harm," said Andrea Gielen, Sc.D., director of the Johns Hopkins Center for Injury Research and Policy and past president of the Society for the Advancement of Violence and Injury Research.

"We know that bicycle crashes lead to around 700 deaths and more than 500,000 emergency room visits each year," said Dr. Gielen. "According to research, wearing an approved helmet in the proper way provides up to an 88% reduction in the risk of head and brain injury for bicyclists of all ages."

Brain injury as a result of sports participation also has garnered more attention in the United States in recent years. However, some states have yet to pass protective laws, according to Amber Williams, executive director of the Safe States Alliance.

"We focused on the growing understanding of steps that can be taken to reduce injuries in youth sports," she said. Prevention measures should include education, removal from play for suspected concussion, and required return-to-play evaluations.

The report includes data on the growing misuse of prescription drugs, particularly painkillers, Ms. Williams said. Sales of prescription painkillers tripled between 1999 and 2010, as did the number of fatal poisonings due to prescription pain medication. "Enough prescription painkillers were prescribed in 2010 to medicate every American adult continually for a month," she noted. The authors found that all but two states had drug-monitoring programs in place.

The key indicators used in the report card are as follows:

– Does the state have a strong youth sports concussion safety law? Fourteen states do not.

– Did the state enact a prescription drug-monitoring program? Two states and the District of Columbia have not.

– Does the state allow people in dating relationships to get protection orders? Only six states do not.

– Did the state receive an A grade according to the teen dating violence laws analysis conducted by the Break the Cycle organization? Forty-four states did not.

– Does the state have a primary seat belt law? Eighteen states do not.

– Does the state require mandatory ignition interlocks for all convicted drunk drivers, even first-time offenders? Thirty-four states and the District of Columbia do not.

– Does the state have a law requiring helmets for all motorcycle riders? Thirty-one states do not.

– Does the state require car seats or booster seats for children at least to age 8? Seventeen states do not.

– Does the state require bicycle helmets for all children? Twenty-nine states do not.

– Did more than 90% of injury discharges from hospitals in the state receive external cause-of-injury coding, which helps researchers and health officials track trends and evaluate prevention programs? Twenty-seven states and the District of Columbia did not.

The report identified other top causes of injury and emerging threats, including bullying, vehicular collisions that occur while the driver is texting, and falls.

According to the report, one person dies from an injury every 3 minutes, and injuries generate $406 billion annually in lifetime costs for medical care and lost productivity. Around 50 million Americans (18% of the population) are medically treated for injuries each year. Each year, more than 29 million people are treated in emergency departments for injuries, 2.8 million are hospitalized, and more than 180,000 die, according to the report. Roughly 9.2 million youth under the age of 20 years are treated in emergency departments for accidental injuries each year, and more than 12,000 of them die.

No conflicts of interest were reported for the authors.

More than half of U.S. states (29) do not require bicycle helmets for all children, and 14 states do not have strong laws to prevent youth concussion during sports, according to a report card on injury prevention released May 22.

The report card is part of a new report on injury prevention – "The Facts Hurt: A State-By-State Injury Prevention Policy Report" – released by the Trust for America’s Health and the Robert Wood Johnson Foundation. The report was developed in partnership with leading injury-prevention experts from the Safe States Alliance and the Society for the Advancement of Violence and Injury Research.

© james boulette/iStockphoto.com

Injuries are the third leading cause of death nationally and are the leading cause of death for Americans between the ages of 1 and 44 years. Almost half of states (24) scored a 5 out of 10 or lower on the report card, which consists of 10 injury-prevention indicators. California and New York received the highest score of 9; Montana and Ohio scored the lowest with 2.

"Overall, we need to redouble our efforts to make safety research and policy a national priority. There’s compelling evidence that we should adopt, implement, and enforce any existing policies and programs to help spare millions of Americans from needless harm," said Andrea Gielen, Sc.D., director of the Johns Hopkins Center for Injury Research and Policy and past president of the Society for the Advancement of Violence and Injury Research.

"We know that bicycle crashes lead to around 700 deaths and more than 500,000 emergency room visits each year," said Dr. Gielen. "According to research, wearing an approved helmet in the proper way provides up to an 88% reduction in the risk of head and brain injury for bicyclists of all ages."

Brain injury as a result of sports participation also has garnered more attention in the United States in recent years. However, some states have yet to pass protective laws, according to Amber Williams, executive director of the Safe States Alliance.

"We focused on the growing understanding of steps that can be taken to reduce injuries in youth sports," she said. Prevention measures should include education, removal from play for suspected concussion, and required return-to-play evaluations.

The report includes data on the growing misuse of prescription drugs, particularly painkillers, Ms. Williams said. Sales of prescription painkillers tripled between 1999 and 2010, as did the number of fatal poisonings due to prescription pain medication. "Enough prescription painkillers were prescribed in 2010 to medicate every American adult continually for a month," she noted. The authors found that all but two states had drug-monitoring programs in place.

The key indicators used in the report card are as follows:

– Does the state have a strong youth sports concussion safety law? Fourteen states do not.

– Did the state enact a prescription drug-monitoring program? Two states and the District of Columbia have not.

– Does the state allow people in dating relationships to get protection orders? Only six states do not.

– Did the state receive an A grade according to the teen dating violence laws analysis conducted by the Break the Cycle organization? Forty-four states did not.

– Does the state have a primary seat belt law? Eighteen states do not.

– Does the state require mandatory ignition interlocks for all convicted drunk drivers, even first-time offenders? Thirty-four states and the District of Columbia do not.

– Does the state have a law requiring helmets for all motorcycle riders? Thirty-one states do not.

– Does the state require car seats or booster seats for children at least to age 8? Seventeen states do not.

– Does the state require bicycle helmets for all children? Twenty-nine states do not.

– Did more than 90% of injury discharges from hospitals in the state receive external cause-of-injury coding, which helps researchers and health officials track trends and evaluate prevention programs? Twenty-seven states and the District of Columbia did not.

The report identified other top causes of injury and emerging threats, including bullying, vehicular collisions that occur while the driver is texting, and falls.

According to the report, one person dies from an injury every 3 minutes, and injuries generate $406 billion annually in lifetime costs for medical care and lost productivity. Around 50 million Americans (18% of the population) are medically treated for injuries each year. Each year, more than 29 million people are treated in emergency departments for injuries, 2.8 million are hospitalized, and more than 180,000 die, according to the report. Roughly 9.2 million youth under the age of 20 years are treated in emergency departments for accidental injuries each year, and more than 12,000 of them die.

No conflicts of interest were reported for the authors.

More than half of U.S. states (29) do not require bicycle helmets for all children, and 14 states do not have strong laws to prevent youth concussion during sports, according to a report card on injury prevention released May 22.

The report card is part of a new report on injury prevention – "The Facts Hurt: A State-By-State Injury Prevention Policy Report" – released by the Trust for America’s Health and the Robert Wood Johnson Foundation. The report was developed in partnership with leading injury-prevention experts from the Safe States Alliance and the Society for the Advancement of Violence and Injury Research.

© james boulette/iStockphoto.com

Injuries are the third leading cause of death nationally and are the leading cause of death for Americans between the ages of 1 and 44 years. Almost half of states (24) scored a 5 out of 10 or lower on the report card, which consists of 10 injury-prevention indicators. California and New York received the highest score of 9; Montana and Ohio scored the lowest with 2.

"Overall, we need to redouble our efforts to make safety research and policy a national priority. There’s compelling evidence that we should adopt, implement, and enforce any existing policies and programs to help spare millions of Americans from needless harm," said Andrea Gielen, Sc.D., director of the Johns Hopkins Center for Injury Research and Policy and past president of the Society for the Advancement of Violence and Injury Research.

"We know that bicycle crashes lead to around 700 deaths and more than 500,000 emergency room visits each year," said Dr. Gielen. "According to research, wearing an approved helmet in the proper way provides up to an 88% reduction in the risk of head and brain injury for bicyclists of all ages."

Brain injury as a result of sports participation also has garnered more attention in the United States in recent years. However, some states have yet to pass protective laws, according to Amber Williams, executive director of the Safe States Alliance.

"We focused on the growing understanding of steps that can be taken to reduce injuries in youth sports," she said. Prevention measures should include education, removal from play for suspected concussion, and required return-to-play evaluations.

The report includes data on the growing misuse of prescription drugs, particularly painkillers, Ms. Williams said. Sales of prescription painkillers tripled between 1999 and 2010, as did the number of fatal poisonings due to prescription pain medication. "Enough prescription painkillers were prescribed in 2010 to medicate every American adult continually for a month," she noted. The authors found that all but two states had drug-monitoring programs in place.

The key indicators used in the report card are as follows:

– Does the state have a strong youth sports concussion safety law? Fourteen states do not.

– Did the state enact a prescription drug-monitoring program? Two states and the District of Columbia have not.

– Does the state allow people in dating relationships to get protection orders? Only six states do not.

– Did the state receive an A grade according to the teen dating violence laws analysis conducted by the Break the Cycle organization? Forty-four states did not.

– Does the state have a primary seat belt law? Eighteen states do not.

– Does the state require mandatory ignition interlocks for all convicted drunk drivers, even first-time offenders? Thirty-four states and the District of Columbia do not.

– Does the state have a law requiring helmets for all motorcycle riders? Thirty-one states do not.

– Does the state require car seats or booster seats for children at least to age 8? Seventeen states do not.

– Does the state require bicycle helmets for all children? Twenty-nine states do not.

– Did more than 90% of injury discharges from hospitals in the state receive external cause-of-injury coding, which helps researchers and health officials track trends and evaluate prevention programs? Twenty-seven states and the District of Columbia did not.

The report identified other top causes of injury and emerging threats, including bullying, vehicular collisions that occur while the driver is texting, and falls.

According to the report, one person dies from an injury every 3 minutes, and injuries generate $406 billion annually in lifetime costs for medical care and lost productivity. Around 50 million Americans (18% of the population) are medically treated for injuries each year. Each year, more than 29 million people are treated in emergency departments for injuries, 2.8 million are hospitalized, and more than 180,000 die, according to the report. Roughly 9.2 million youth under the age of 20 years are treated in emergency departments for accidental injuries each year, and more than 12,000 of them die.

No conflicts of interest were reported for the authors.

SAN DIEGO – Lymph node removal during gastrointestinal cancer surgery remains underperformed in a large proportion of patients in the United States, although the median number of resected nodes increased from 1998 to 2009.

Those are the key findings of a 10-year analysis of medical records from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) database.

Several reports in the literature show a correlation between long-term survival and the removal of possibly metastatic lymph nodes along with the cancerous organ during surgery, Dr. Attila Dubecz explained in an interview at the annual Digestive Disease Week. There are also survival differences based on sex, race or poverty status, and differences in lymph node removal between these groups in certain cancer types, he said. "We wanted to determine if these differences are more related to cancer types therefore the type of operation, for example or to these underprivileged groups."

Using SEER data from 1998 to 2009, Dr. Dubecz of Klinikum Nürnberg (Germany) and his colleagues identified 326,243 patients with a surgically treated GI malignancy. This included 13,165 malignancies in the esophagus, 18,588 in the stomach, 7,666 in the small bowel, 232,345 in the colon, 42,338 in the rectum, and 12,141 in the pancreas.

Adequate lymphadenectomy was defined as removal of at least 15 lymph nodes for cancer of the esophagus and the stomach; at least 12 for cancer of the small bowel, colon, and rectum; and at least 15 for cancer of the pancreas. The researchers evaluated the median number of lymph nodes removed and the prevalence of adequate and/or no lymphadenectomy for each cancer type over the 10-year period. They used multivariate logistic regression analysis to identify factors predicting adequate lymphadenectomy.

Dr. Dubecz, a surgeon, reported that the median number of excised nodes improved over the 10-year period in all types of cancer: from 7 to 13 in esophageal cancer, 8 to 12 in stomach cancer, 2 to 7 in small bowel cancer, 9 to 16 in colon cancer, 8 to 13 in rectal cancer, and 7 to 13 in pancreatic cancer.

In addition, the percentage of patients with an adequate lymphadenectomy (a median of 49% for all types) steadily increased and those with zero nodes removed (a median of 6% for all types) steadily decreased in all types of cancer, "although both remained far from ideal," the researchers wrote.

By 2009, the percentage of patients with adequate lymphadenectomy was 43% for esophageal cancer, 42% for stomach cancer, 35% for small bowel cancer, 77% for colon cancer, 61% for rectal cancer and 42% for pancreatic cancer. Men, patients older than age 65, or those undergoing surgical therapy earlier in the study period and living in areas with high poverty rates were significantly less likely to receive adequate lymphadenectomy (P less than .0001 for all groups).

"The main surprise was that race was an insignificant factor, and gender, age, and socioeconomic differences between the groups with adequate versus inadequate lymph node dissection were also much less [than] between the groups of different cancer types," Dr. Dubecz said at the annual meeting of the Digestive Disease Week.

Dr. Dubecz acknowledged certain limitations of the study, including the potential for misclassification of patient information in the SEER database. "Furthermore, despite being advocated by several practice organizations and consensus panels, the definitions of adequate lymphadenectomy used in this study are not universally accepted," he noted. "Third, our analyses are limited to the available variables in the SEER database with no information regarding patient insurance status, comorbidities, body mass index, or [neo]adjuvant chemotherapy, which could influence lymph node dissection and the disparities."

Dr. Dubecz said he had no relevant financial disclosures.

SAN DIEGO – Lymph node removal during gastrointestinal cancer surgery remains underperformed in a large proportion of patients in the United States, although the median number of resected nodes increased from 1998 to 2009.

Those are the key findings of a 10-year analysis of medical records from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) database.

Several reports in the literature show a correlation between long-term survival and the removal of possibly metastatic lymph nodes along with the cancerous organ during surgery, Dr. Attila Dubecz explained in an interview at the annual Digestive Disease Week. There are also survival differences based on sex, race or poverty status, and differences in lymph node removal between these groups in certain cancer types, he said. "We wanted to determine if these differences are more related to cancer types therefore the type of operation, for example or to these underprivileged groups."

Using SEER data from 1998 to 2009, Dr. Dubecz of Klinikum Nürnberg (Germany) and his colleagues identified 326,243 patients with a surgically treated GI malignancy. This included 13,165 malignancies in the esophagus, 18,588 in the stomach, 7,666 in the small bowel, 232,345 in the colon, 42,338 in the rectum, and 12,141 in the pancreas.

Adequate lymphadenectomy was defined as removal of at least 15 lymph nodes for cancer of the esophagus and the stomach; at least 12 for cancer of the small bowel, colon, and rectum; and at least 15 for cancer of the pancreas. The researchers evaluated the median number of lymph nodes removed and the prevalence of adequate and/or no lymphadenectomy for each cancer type over the 10-year period. They used multivariate logistic regression analysis to identify factors predicting adequate lymphadenectomy.

Dr. Dubecz, a surgeon, reported that the median number of excised nodes improved over the 10-year period in all types of cancer: from 7 to 13 in esophageal cancer, 8 to 12 in stomach cancer, 2 to 7 in small bowel cancer, 9 to 16 in colon cancer, 8 to 13 in rectal cancer, and 7 to 13 in pancreatic cancer.

In addition, the percentage of patients with an adequate lymphadenectomy (a median of 49% for all types) steadily increased and those with zero nodes removed (a median of 6% for all types) steadily decreased in all types of cancer, "although both remained far from ideal," the researchers wrote.

By 2009, the percentage of patients with adequate lymphadenectomy was 43% for esophageal cancer, 42% for stomach cancer, 35% for small bowel cancer, 77% for colon cancer, 61% for rectal cancer and 42% for pancreatic cancer. Men, patients older than age 65, or those undergoing surgical therapy earlier in the study period and living in areas with high poverty rates were significantly less likely to receive adequate lymphadenectomy (P less than .0001 for all groups).

"The main surprise was that race was an insignificant factor, and gender, age, and socioeconomic differences between the groups with adequate versus inadequate lymph node dissection were also much less [than] between the groups of different cancer types," Dr. Dubecz said at the annual meeting of the Digestive Disease Week.

Dr. Dubecz acknowledged certain limitations of the study, including the potential for misclassification of patient information in the SEER database. "Furthermore, despite being advocated by several practice organizations and consensus panels, the definitions of adequate lymphadenectomy used in this study are not universally accepted," he noted. "Third, our analyses are limited to the available variables in the SEER database with no information regarding patient insurance status, comorbidities, body mass index, or [neo]adjuvant chemotherapy, which could influence lymph node dissection and the disparities."

Dr. Dubecz said he had no relevant financial disclosures.

SAN DIEGO – Lymph node removal during gastrointestinal cancer surgery remains underperformed in a large proportion of patients in the United States, although the median number of resected nodes increased from 1998 to 2009.

Those are the key findings of a 10-year analysis of medical records from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) database.

Several reports in the literature show a correlation between long-term survival and the removal of possibly metastatic lymph nodes along with the cancerous organ during surgery, Dr. Attila Dubecz explained in an interview at the annual Digestive Disease Week. There are also survival differences based on sex, race or poverty status, and differences in lymph node removal between these groups in certain cancer types, he said. "We wanted to determine if these differences are more related to cancer types therefore the type of operation, for example or to these underprivileged groups."

Using SEER data from 1998 to 2009, Dr. Dubecz of Klinikum Nürnberg (Germany) and his colleagues identified 326,243 patients with a surgically treated GI malignancy. This included 13,165 malignancies in the esophagus, 18,588 in the stomach, 7,666 in the small bowel, 232,345 in the colon, 42,338 in the rectum, and 12,141 in the pancreas.

Adequate lymphadenectomy was defined as removal of at least 15 lymph nodes for cancer of the esophagus and the stomach; at least 12 for cancer of the small bowel, colon, and rectum; and at least 15 for cancer of the pancreas. The researchers evaluated the median number of lymph nodes removed and the prevalence of adequate and/or no lymphadenectomy for each cancer type over the 10-year period. They used multivariate logistic regression analysis to identify factors predicting adequate lymphadenectomy.

Dr. Dubecz, a surgeon, reported that the median number of excised nodes improved over the 10-year period in all types of cancer: from 7 to 13 in esophageal cancer, 8 to 12 in stomach cancer, 2 to 7 in small bowel cancer, 9 to 16 in colon cancer, 8 to 13 in rectal cancer, and 7 to 13 in pancreatic cancer.

In addition, the percentage of patients with an adequate lymphadenectomy (a median of 49% for all types) steadily increased and those with zero nodes removed (a median of 6% for all types) steadily decreased in all types of cancer, "although both remained far from ideal," the researchers wrote.

By 2009, the percentage of patients with adequate lymphadenectomy was 43% for esophageal cancer, 42% for stomach cancer, 35% for small bowel cancer, 77% for colon cancer, 61% for rectal cancer and 42% for pancreatic cancer. Men, patients older than age 65, or those undergoing surgical therapy earlier in the study period and living in areas with high poverty rates were significantly less likely to receive adequate lymphadenectomy (P less than .0001 for all groups).

"The main surprise was that race was an insignificant factor, and gender, age, and socioeconomic differences between the groups with adequate versus inadequate lymph node dissection were also much less [than] between the groups of different cancer types," Dr. Dubecz said at the annual meeting of the Digestive Disease Week.

Dr. Dubecz acknowledged certain limitations of the study, including the potential for misclassification of patient information in the SEER database. "Furthermore, despite being advocated by several practice organizations and consensus panels, the definitions of adequate lymphadenectomy used in this study are not universally accepted," he noted. "Third, our analyses are limited to the available variables in the SEER database with no information regarding patient insurance status, comorbidities, body mass index, or [neo]adjuvant chemotherapy, which could influence lymph node dissection and the disparities."

Dr. Dubecz said he had no relevant financial disclosures.

Obese children seem to have gotten fatter around the middle over time, and that development may account in part for an observed increase in suspected nonalcoholic fatty liver disease among adolescents.

Nonalcoholic fatty liver disease (NAFLD) in adolescents has nearly tripled from 1998 to 2008, Dr. Miriam Vos said during a teleconference reporting the results of an observational study that she will present on Monday, May 21, at Digestive Disease Week 2012. In a review of nationally representative data from the National Health and Nutrition Examination Survey (NHANES), the tripling of NAFLD cases outpaced a near doubling of adolescent obesity during the same period.

Photo picmov/iStockphoto.com

Thus, "our findings suggest that obesity alone does not explain the growing prevalence of the liver disease," she said.

The most common cause of chronic pediatric liver disease, NAFLD has been associated with hypertension, type 2 diabetes, metabolic abnormalities, liver damage, and cancer. Anecdotal data have previously suggested a risk in NAFLD that was linked to obesity in children, but "this finding has not been confirmed in previous studies," said Dr. Vos of Children’s Healthcare of Atlanta. "We wanted to know whether the rates seem high because clinicians are looking more closely [for NAFLD] or because there really are more cases."

The researchers examined the NHANES data sets from 1988 to 2008, which account for 10,359 12- to 18-year-olds after those with incomplete information or known liver disease were excluded.

More conservative cutoff parameters for suspected NAFLD were implemented during the period of the study, so the researchers conducted their analyses using both cutoffs to allow for comparisons with earlier studies, Dr. Vos explained. "Based on the earlier cut-off, [NAFLD] was suspected in adolescents with a BMI in the 85th percentile or higher, and elevated [ALT] levels (defined as greater than 30)," she said. The newly recommended ALT cutoffs are sex-specific; NAFLD is suspected in adolescents in the same BMI range, but at ALT levels greater than 25.8 for boys and 22.1 for girls (Gastroenterology 2010;138:1357-64).

When the sex-specific cutoffs were used, NAFLD rates "increased among all adolescents, from 3.6% to 9.9%," she said.

Dr. Vos said that age, sex, race, and percentage of overweight adolescents did not differ from 1988 to 2008; however, the percentage of overweight adolescents who were obese increased significantly (from 11.2% to 20.6%).

Among overweight adolescents, the prevalence of elevated ALT levels was 13.2% in 2007-2008, which did not represent a significant linear increase over time. Among obese adolescents, however, elevated ALT levels rose from 16.7% to 36.9% from 1988 to 2008. Similar increases were observed in this group when the previous ALT cutoff of 30 was used, as well.

The findings may be limited somewhat by the study’s inclusion criteria, according to Dr. Vos. "It’s tricky to identify NAFLD using population data like this, so we set our definition to look at overweight children who also have elevated serum ALT. By choosing to look only at the overweight children, we might have missed some cases."

Even so, the findings are important from a public health standpoint. "We need to know this kind of information to plan programs that tackle the prevention and treatment of NAFLD, and it also helps us look for clues about why so many children are getting fatty liver disease," Dr. Vos said.

"We need to look beyond just the increase in obesity among children." For example, a further analysis of the cross-sectional data found a parallel increase between NAFLD prevalence and waist circumference. "While the cross-sectional design of our study can’t point to causation, we can hypothesize that the increase in NAFLD may be linked to an increase in visceral adiposity or centrally located fat in kids today," she said, noting that what might be causing such increases is fodder for additional investigation.

Dr. Vos has received financial support in the form of a career award from the National Institute of Diabetes and Digestive and Kidney Diseases, and from the Children’s Digestive Health and Nutrition Foundation. She is the author of "The No-Diet Obesity Solution for Kids" (Bethesda, Md.: AGA Institute Press, 2009), for which she receives royalties.

Obese children seem to have gotten fatter around the middle over time, and that development may account in part for an observed increase in suspected nonalcoholic fatty liver disease among adolescents.

Nonalcoholic fatty liver disease (NAFLD) in adolescents has nearly tripled from 1998 to 2008, Dr. Miriam Vos said during a teleconference reporting the results of an observational study that she will present on Monday, May 21, at Digestive Disease Week 2012. In a review of nationally representative data from the National Health and Nutrition Examination Survey (NHANES), the tripling of NAFLD cases outpaced a near doubling of adolescent obesity during the same period.

Photo picmov/iStockphoto.com

Thus, "our findings suggest that obesity alone does not explain the growing prevalence of the liver disease," she said.

The most common cause of chronic pediatric liver disease, NAFLD has been associated with hypertension, type 2 diabetes, metabolic abnormalities, liver damage, and cancer. Anecdotal data have previously suggested a risk in NAFLD that was linked to obesity in children, but "this finding has not been confirmed in previous studies," said Dr. Vos of Children’s Healthcare of Atlanta. "We wanted to know whether the rates seem high because clinicians are looking more closely [for NAFLD] or because there really are more cases."

The researchers examined the NHANES data sets from 1988 to 2008, which account for 10,359 12- to 18-year-olds after those with incomplete information or known liver disease were excluded.

More conservative cutoff parameters for suspected NAFLD were implemented during the period of the study, so the researchers conducted their analyses using both cutoffs to allow for comparisons with earlier studies, Dr. Vos explained. "Based on the earlier cut-off, [NAFLD] was suspected in adolescents with a BMI in the 85th percentile or higher, and elevated [ALT] levels (defined as greater than 30)," she said. The newly recommended ALT cutoffs are sex-specific; NAFLD is suspected in adolescents in the same BMI range, but at ALT levels greater than 25.8 for boys and 22.1 for girls (Gastroenterology 2010;138:1357-64).

When the sex-specific cutoffs were used, NAFLD rates "increased among all adolescents, from 3.6% to 9.9%," she said.

Dr. Vos said that age, sex, race, and percentage of overweight adolescents did not differ from 1988 to 2008; however, the percentage of overweight adolescents who were obese increased significantly (from 11.2% to 20.6%).

Among overweight adolescents, the prevalence of elevated ALT levels was 13.2% in 2007-2008, which did not represent a significant linear increase over time. Among obese adolescents, however, elevated ALT levels rose from 16.7% to 36.9% from 1988 to 2008. Similar increases were observed in this group when the previous ALT cutoff of 30 was used, as well.

The findings may be limited somewhat by the study’s inclusion criteria, according to Dr. Vos. "It’s tricky to identify NAFLD using population data like this, so we set our definition to look at overweight children who also have elevated serum ALT. By choosing to look only at the overweight children, we might have missed some cases."

Even so, the findings are important from a public health standpoint. "We need to know this kind of information to plan programs that tackle the prevention and treatment of NAFLD, and it also helps us look for clues about why so many children are getting fatty liver disease," Dr. Vos said.

"We need to look beyond just the increase in obesity among children." For example, a further analysis of the cross-sectional data found a parallel increase between NAFLD prevalence and waist circumference. "While the cross-sectional design of our study can’t point to causation, we can hypothesize that the increase in NAFLD may be linked to an increase in visceral adiposity or centrally located fat in kids today," she said, noting that what might be causing such increases is fodder for additional investigation.

Dr. Vos has received financial support in the form of a career award from the National Institute of Diabetes and Digestive and Kidney Diseases, and from the Children’s Digestive Health and Nutrition Foundation. She is the author of "The No-Diet Obesity Solution for Kids" (Bethesda, Md.: AGA Institute Press, 2009), for which she receives royalties.

Obese children seem to have gotten fatter around the middle over time, and that development may account in part for an observed increase in suspected nonalcoholic fatty liver disease among adolescents.

Nonalcoholic fatty liver disease (NAFLD) in adolescents has nearly tripled from 1998 to 2008, Dr. Miriam Vos said during a teleconference reporting the results of an observational study that she will present on Monday, May 21, at Digestive Disease Week 2012. In a review of nationally representative data from the National Health and Nutrition Examination Survey (NHANES), the tripling of NAFLD cases outpaced a near doubling of adolescent obesity during the same period.

Photo picmov/iStockphoto.com

Thus, "our findings suggest that obesity alone does not explain the growing prevalence of the liver disease," she said.

The most common cause of chronic pediatric liver disease, NAFLD has been associated with hypertension, type 2 diabetes, metabolic abnormalities, liver damage, and cancer. Anecdotal data have previously suggested a risk in NAFLD that was linked to obesity in children, but "this finding has not been confirmed in previous studies," said Dr. Vos of Children’s Healthcare of Atlanta. "We wanted to know whether the rates seem high because clinicians are looking more closely [for NAFLD] or because there really are more cases."

The researchers examined the NHANES data sets from 1988 to 2008, which account for 10,359 12- to 18-year-olds after those with incomplete information or known liver disease were excluded.

More conservative cutoff parameters for suspected NAFLD were implemented during the period of the study, so the researchers conducted their analyses using both cutoffs to allow for comparisons with earlier studies, Dr. Vos explained. "Based on the earlier cut-off, [NAFLD] was suspected in adolescents with a BMI in the 85th percentile or higher, and elevated [ALT] levels (defined as greater than 30)," she said. The newly recommended ALT cutoffs are sex-specific; NAFLD is suspected in adolescents in the same BMI range, but at ALT levels greater than 25.8 for boys and 22.1 for girls (Gastroenterology 2010;138:1357-64).

When the sex-specific cutoffs were used, NAFLD rates "increased among all adolescents, from 3.6% to 9.9%," she said.

Dr. Vos said that age, sex, race, and percentage of overweight adolescents did not differ from 1988 to 2008; however, the percentage of overweight adolescents who were obese increased significantly (from 11.2% to 20.6%).

Among overweight adolescents, the prevalence of elevated ALT levels was 13.2% in 2007-2008, which did not represent a significant linear increase over time. Among obese adolescents, however, elevated ALT levels rose from 16.7% to 36.9% from 1988 to 2008. Similar increases were observed in this group when the previous ALT cutoff of 30 was used, as well.

The findings may be limited somewhat by the study’s inclusion criteria, according to Dr. Vos. "It’s tricky to identify NAFLD using population data like this, so we set our definition to look at overweight children who also have elevated serum ALT. By choosing to look only at the overweight children, we might have missed some cases."

Even so, the findings are important from a public health standpoint. "We need to know this kind of information to plan programs that tackle the prevention and treatment of NAFLD, and it also helps us look for clues about why so many children are getting fatty liver disease," Dr. Vos said.

"We need to look beyond just the increase in obesity among children." For example, a further analysis of the cross-sectional data found a parallel increase between NAFLD prevalence and waist circumference. "While the cross-sectional design of our study can’t point to causation, we can hypothesize that the increase in NAFLD may be linked to an increase in visceral adiposity or centrally located fat in kids today," she said, noting that what might be causing such increases is fodder for additional investigation.

Dr. Vos has received financial support in the form of a career award from the National Institute of Diabetes and Digestive and Kidney Diseases, and from the Children’s Digestive Health and Nutrition Foundation. She is the author of "The No-Diet Obesity Solution for Kids" (Bethesda, Md.: AGA Institute Press, 2009), for which she receives royalties.

The FDA generally approves drugs faster than its Canadian and European counterparts, according to a study published in this week’s edition of NEJM.

The researchers say these results refute criticisms that the drug approval process in the US is slow and that agencies in other countries tend to approve new therapies first.

“The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications,” said lead study author Nicholas Downing, a medical student at Yale University.

He and his colleagues decided to conduct this study because there have been no recent comparisons of the FDA’s review speed with that of agencies in other countries.

So the researchers reviewed drug approval decisions made by the FDA, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. The team said they chose Health Canada and the EMA as comparisons because these agencies face similar pressures to approve new drugs quickly while ensuring they don’t put patients at risk.

The investigators studied each regulator’s database of drug approvals to identify novel therapeutics, as well as the timing of key regulatory events. They then calculated each agency’s review speed.

The median total time to review a new drug application was 322 days at the FDA, 366 days at the EMA, and 393 days at Health Canada.

“Among the subsample of drugs approved for all 3 regulators, the FDA’s reviews were over 3 months faster than those of the EMA or Health Canada,” Downing said. “The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews.”

The researchers also found that, during the review period, the FDA approved 225 new drugs, the EMA approved 186, and Health Canada approved 99. Additionally, of the therapies that have been approved by all 3 agencies, most drugs were first approved in the US.

“[W]e found that 64% of medicines approved in both the US and in Europe were approved for US patients first,” Downing said. “And 86% of medicines approved in both the US and Canada were also approved first in the US.”

Downing and his colleagues noted that this study has 2 key limitations. First, the researchers didn’t account for drugs that were ultimately rejected, as the regulatory agencies don’t release review times for drugs that are never approved. However, the team also pointed out that the FDA approves more than 80% of its applications, so the exclusion may not have made much of an impact.

Secondly, the study included only new molecular entities and original biologic agents. In order to get a more accurate reading on the regulatory review process, research would need to evaluate the review of generic drugs, reformulated drugs, combination therapies, and medical devices.

The FDA generally approves drugs faster than its Canadian and European counterparts, according to a study published in this week’s edition of NEJM.

The researchers say these results refute criticisms that the drug approval process in the US is slow and that agencies in other countries tend to approve new therapies first.

“The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications,” said lead study author Nicholas Downing, a medical student at Yale University.

He and his colleagues decided to conduct this study because there have been no recent comparisons of the FDA’s review speed with that of agencies in other countries.

So the researchers reviewed drug approval decisions made by the FDA, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. The team said they chose Health Canada and the EMA as comparisons because these agencies face similar pressures to approve new drugs quickly while ensuring they don’t put patients at risk.

The investigators studied each regulator’s database of drug approvals to identify novel therapeutics, as well as the timing of key regulatory events. They then calculated each agency’s review speed.

The median total time to review a new drug application was 322 days at the FDA, 366 days at the EMA, and 393 days at Health Canada.

“Among the subsample of drugs approved for all 3 regulators, the FDA’s reviews were over 3 months faster than those of the EMA or Health Canada,” Downing said. “The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews.”

The researchers also found that, during the review period, the FDA approved 225 new drugs, the EMA approved 186, and Health Canada approved 99. Additionally, of the therapies that have been approved by all 3 agencies, most drugs were first approved in the US.

“[W]e found that 64% of medicines approved in both the US and in Europe were approved for US patients first,” Downing said. “And 86% of medicines approved in both the US and Canada were also approved first in the US.”

Downing and his colleagues noted that this study has 2 key limitations. First, the researchers didn’t account for drugs that were ultimately rejected, as the regulatory agencies don’t release review times for drugs that are never approved. However, the team also pointed out that the FDA approves more than 80% of its applications, so the exclusion may not have made much of an impact.

Secondly, the study included only new molecular entities and original biologic agents. In order to get a more accurate reading on the regulatory review process, research would need to evaluate the review of generic drugs, reformulated drugs, combination therapies, and medical devices.

The FDA generally approves drugs faster than its Canadian and European counterparts, according to a study published in this week’s edition of NEJM.

The researchers say these results refute criticisms that the drug approval process in the US is slow and that agencies in other countries tend to approve new therapies first.

“The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications,” said lead study author Nicholas Downing, a medical student at Yale University.

He and his colleagues decided to conduct this study because there have been no recent comparisons of the FDA’s review speed with that of agencies in other countries.

So the researchers reviewed drug approval decisions made by the FDA, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. The team said they chose Health Canada and the EMA as comparisons because these agencies face similar pressures to approve new drugs quickly while ensuring they don’t put patients at risk.

The investigators studied each regulator’s database of drug approvals to identify novel therapeutics, as well as the timing of key regulatory events. They then calculated each agency’s review speed.

The median total time to review a new drug application was 322 days at the FDA, 366 days at the EMA, and 393 days at Health Canada.

“Among the subsample of drugs approved for all 3 regulators, the FDA’s reviews were over 3 months faster than those of the EMA or Health Canada,” Downing said. “The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews.”

The researchers also found that, during the review period, the FDA approved 225 new drugs, the EMA approved 186, and Health Canada approved 99. Additionally, of the therapies that have been approved by all 3 agencies, most drugs were first approved in the US.

“[W]e found that 64% of medicines approved in both the US and in Europe were approved for US patients first,” Downing said. “And 86% of medicines approved in both the US and Canada were also approved first in the US.”

Downing and his colleagues noted that this study has 2 key limitations. First, the researchers didn’t account for drugs that were ultimately rejected, as the regulatory agencies don’t release review times for drugs that are never approved. However, the team also pointed out that the FDA approves more than 80% of its applications, so the exclusion may not have made much of an impact.

Secondly, the study included only new molecular entities and original biologic agents. In order to get a more accurate reading on the regulatory review process, research would need to evaluate the review of generic drugs, reformulated drugs, combination therapies, and medical devices.