Antiviral therapy may reduce the risk of hepatocellular carcinoma in patients with hepatitis C infections, Dr. Nina Kimer reported in the Oct. 22 issue of BMJ Open, published online.

Moreover, the effect seems to persist regardless of whether sustained virologic response is achieved.

Dr. Kimer, of Copenhagen University Hospital, Hvidovre, Denmark, and colleagues conducted a meta-analysis of trials looking at hepatitis C-related cirrhosis or fibrosis (BMJ Open 2012;2:e001313 [doi:10.1136/bmjopen-2012-001313]).

Courtesy US. Dept of Veterans Affairs

The primary analysis focused on randomized controlled trials, although prospective cohort studies with control groups were included in sensitivity analyses.

The authors searched the Cochrane Library, PubMed, EMBASE, and Web of Science databases, as well as reference lists from relevant papers, conference proceedings, and the World Health Organization Trial Search Portal.

Studies looking at HIV and chronic hepatitis B were excluded, for a total of eight randomized trials and five prospective cohort studies.

The duration of therapy (which included pegylated interferon in two trials, interferon plus ribavirin in one trial, and interferon monotherapy in the remaining trials) varied from 1 to 5 years. Follow-up ranged from 2 to 8.7 years.

Overall, the authors found that 81 of 1,156 patients who received antiviral therapy and 129 of 1,074 control patients who received no therapy developed hepatocellular carcinoma.

The relative risk for antiviral therapy, compared with no treatment, was 0.53 (95% confidence interval, 0.34-0.81).

"The corresponding number needed to treat to prevent one case of [hepatocellular carcinoma] was eight patients," added the researchers.

And while the effect of antivirals was more pronounced among patients with a virological response (RR 0.15; 95% CI, 0.05-0.45), there was nevertheless a clear reduction in risk for nonresponders to antivirals, with a relative risk of 0.57, compared with controls (95% CI 0.37-0.85).

"Although the intervention was more beneficial among sustained virological responders than nonresponders, there was a clear effect in both patient groups. ... Antiviral therapy may have beneficial effects on the risk of developing HCC that are unrelated to the virological response."

On the other hand, there was no reported effect of antiviral therapy on all-cause mortality, liver-related mortality, or liver-related morbidity in this population.

Dr. Kimer conceded several limitations to this analysis. "Only two of the included trials evaluated pegylated interferon, which is the current standard treatment for chronic hepatitis C."

Moreover, the duration of treatment in several included studies was "relatively long, which may increase the proportion of responders."

Finally, Dr. Kimer added that the researchers were unable to perform subgroup analysis to determine which treatment duration or dose is best.

"Based on the duration of follow-up and the lack of clear evidence concerning morbidity or mortality, we cannot exclude that interferon delays rather than prevents carcinogenesis," concluded the investigators.

Nevertheless, the "protection from HCC might be even better among patients in current antiviral therapy since the proportion of virological responders continues to increase with ongoing improvements in therapy," they wrote.

"Additional randomized trials with longer follow-up are still warranted to determine whether this is the case," they noted.

The authors disclosed having no outside funding and no competing interests related to this study.

Antiviral therapy may reduce the risk of hepatocellular carcinoma in patients with hepatitis C infections, Dr. Nina Kimer reported in the Oct. 22 issue of BMJ Open, published online.

Moreover, the effect seems to persist regardless of whether sustained virologic response is achieved.

Dr. Kimer, of Copenhagen University Hospital, Hvidovre, Denmark, and colleagues conducted a meta-analysis of trials looking at hepatitis C-related cirrhosis or fibrosis (BMJ Open 2012;2:e001313 [doi:10.1136/bmjopen-2012-001313]).

Courtesy US. Dept of Veterans Affairs

The primary analysis focused on randomized controlled trials, although prospective cohort studies with control groups were included in sensitivity analyses.

The authors searched the Cochrane Library, PubMed, EMBASE, and Web of Science databases, as well as reference lists from relevant papers, conference proceedings, and the World Health Organization Trial Search Portal.

Studies looking at HIV and chronic hepatitis B were excluded, for a total of eight randomized trials and five prospective cohort studies.

The duration of therapy (which included pegylated interferon in two trials, interferon plus ribavirin in one trial, and interferon monotherapy in the remaining trials) varied from 1 to 5 years. Follow-up ranged from 2 to 8.7 years.

Overall, the authors found that 81 of 1,156 patients who received antiviral therapy and 129 of 1,074 control patients who received no therapy developed hepatocellular carcinoma.

The relative risk for antiviral therapy, compared with no treatment, was 0.53 (95% confidence interval, 0.34-0.81).

"The corresponding number needed to treat to prevent one case of [hepatocellular carcinoma] was eight patients," added the researchers.

And while the effect of antivirals was more pronounced among patients with a virological response (RR 0.15; 95% CI, 0.05-0.45), there was nevertheless a clear reduction in risk for nonresponders to antivirals, with a relative risk of 0.57, compared with controls (95% CI 0.37-0.85).

"Although the intervention was more beneficial among sustained virological responders than nonresponders, there was a clear effect in both patient groups. ... Antiviral therapy may have beneficial effects on the risk of developing HCC that are unrelated to the virological response."

On the other hand, there was no reported effect of antiviral therapy on all-cause mortality, liver-related mortality, or liver-related morbidity in this population.

Dr. Kimer conceded several limitations to this analysis. "Only two of the included trials evaluated pegylated interferon, which is the current standard treatment for chronic hepatitis C."

Moreover, the duration of treatment in several included studies was "relatively long, which may increase the proportion of responders."

Finally, Dr. Kimer added that the researchers were unable to perform subgroup analysis to determine which treatment duration or dose is best.

"Based on the duration of follow-up and the lack of clear evidence concerning morbidity or mortality, we cannot exclude that interferon delays rather than prevents carcinogenesis," concluded the investigators.

Nevertheless, the "protection from HCC might be even better among patients in current antiviral therapy since the proportion of virological responders continues to increase with ongoing improvements in therapy," they wrote.

"Additional randomized trials with longer follow-up are still warranted to determine whether this is the case," they noted.

The authors disclosed having no outside funding and no competing interests related to this study.

Antiviral therapy may reduce the risk of hepatocellular carcinoma in patients with hepatitis C infections, Dr. Nina Kimer reported in the Oct. 22 issue of BMJ Open, published online.

Moreover, the effect seems to persist regardless of whether sustained virologic response is achieved.

Dr. Kimer, of Copenhagen University Hospital, Hvidovre, Denmark, and colleagues conducted a meta-analysis of trials looking at hepatitis C-related cirrhosis or fibrosis (BMJ Open 2012;2:e001313 [doi:10.1136/bmjopen-2012-001313]).

Courtesy US. Dept of Veterans Affairs

The primary analysis focused on randomized controlled trials, although prospective cohort studies with control groups were included in sensitivity analyses.

The authors searched the Cochrane Library, PubMed, EMBASE, and Web of Science databases, as well as reference lists from relevant papers, conference proceedings, and the World Health Organization Trial Search Portal.

Studies looking at HIV and chronic hepatitis B were excluded, for a total of eight randomized trials and five prospective cohort studies.

The duration of therapy (which included pegylated interferon in two trials, interferon plus ribavirin in one trial, and interferon monotherapy in the remaining trials) varied from 1 to 5 years. Follow-up ranged from 2 to 8.7 years.

Overall, the authors found that 81 of 1,156 patients who received antiviral therapy and 129 of 1,074 control patients who received no therapy developed hepatocellular carcinoma.

The relative risk for antiviral therapy, compared with no treatment, was 0.53 (95% confidence interval, 0.34-0.81).

"The corresponding number needed to treat to prevent one case of [hepatocellular carcinoma] was eight patients," added the researchers.

And while the effect of antivirals was more pronounced among patients with a virological response (RR 0.15; 95% CI, 0.05-0.45), there was nevertheless a clear reduction in risk for nonresponders to antivirals, with a relative risk of 0.57, compared with controls (95% CI 0.37-0.85).

"Although the intervention was more beneficial among sustained virological responders than nonresponders, there was a clear effect in both patient groups. ... Antiviral therapy may have beneficial effects on the risk of developing HCC that are unrelated to the virological response."

On the other hand, there was no reported effect of antiviral therapy on all-cause mortality, liver-related mortality, or liver-related morbidity in this population.

Dr. Kimer conceded several limitations to this analysis. "Only two of the included trials evaluated pegylated interferon, which is the current standard treatment for chronic hepatitis C."

Moreover, the duration of treatment in several included studies was "relatively long, which may increase the proportion of responders."

Finally, Dr. Kimer added that the researchers were unable to perform subgroup analysis to determine which treatment duration or dose is best.

"Based on the duration of follow-up and the lack of clear evidence concerning morbidity or mortality, we cannot exclude that interferon delays rather than prevents carcinogenesis," concluded the investigators.

Nevertheless, the "protection from HCC might be even better among patients in current antiviral therapy since the proportion of virological responders continues to increase with ongoing improvements in therapy," they wrote.

"Additional randomized trials with longer follow-up are still warranted to determine whether this is the case," they noted.

The authors disclosed having no outside funding and no competing interests related to this study.

NEW YORK—Hospitalists are poised to become key allies with hospital quality and safety officers nationwide, according to veteran hospitalist Jennifer Myers, MD, FHM, director of quality and safety education for Penn Medicine in Philadelphia.

Addressing hospitalists at the seventh annual Mid-Atlantic Hospital Medicine Symposium at Mount Sinai School of Medicine in New York, Dr. Myers said that while the challenges associated with quality improvement (QI) are many, HM leaders have the in-house relationships and respect to push the issue.

"There's really no other specialty more perfectly poised to lead this work," she told more than 180 symposium attendees Friday.

Dr. Myers, in an address titled "Enhancing Patient Safety," told The Hospitalist that HM leaders pursue three broad goals: to participate in QI programs already in place, to help create or foster a culture focused on addressing mistakes, and to teach those lessons to young physicians.

She urged physicians to actively report on mistakes and near misses, and earnestly address the processes that led to them. If a vehicle to discuss the mistakes doesn't exist at an institution, hospitalists can push to start one, she said. If a hospital doesn't have an electronic incident reporting system, a hospitalist can push to get one. "This is the goal," Dr. Myers added. "People coming to work and feeling they can be safe and report errors in the spirit of improvement."

She noted that many hospitalists already oversee quality and safety programs without any formal training. She recommended some of those physicians consider the Quality and Safety Educators Academy (QSEA), a three-day academy designed as a faculty development program and sponsored by SHM and the Alliance for Academic Internal Medicine (AAIM). The academy is March 7-9, 2013, in Tempe, Ariz.

NEW YORK—Hospitalists are poised to become key allies with hospital quality and safety officers nationwide, according to veteran hospitalist Jennifer Myers, MD, FHM, director of quality and safety education for Penn Medicine in Philadelphia.

Addressing hospitalists at the seventh annual Mid-Atlantic Hospital Medicine Symposium at Mount Sinai School of Medicine in New York, Dr. Myers said that while the challenges associated with quality improvement (QI) are many, HM leaders have the in-house relationships and respect to push the issue.

"There's really no other specialty more perfectly poised to lead this work," she told more than 180 symposium attendees Friday.

Dr. Myers, in an address titled "Enhancing Patient Safety," told The Hospitalist that HM leaders pursue three broad goals: to participate in QI programs already in place, to help create or foster a culture focused on addressing mistakes, and to teach those lessons to young physicians.

She urged physicians to actively report on mistakes and near misses, and earnestly address the processes that led to them. If a vehicle to discuss the mistakes doesn't exist at an institution, hospitalists can push to start one, she said. If a hospital doesn't have an electronic incident reporting system, a hospitalist can push to get one. "This is the goal," Dr. Myers added. "People coming to work and feeling they can be safe and report errors in the spirit of improvement."

She noted that many hospitalists already oversee quality and safety programs without any formal training. She recommended some of those physicians consider the Quality and Safety Educators Academy (QSEA), a three-day academy designed as a faculty development program and sponsored by SHM and the Alliance for Academic Internal Medicine (AAIM). The academy is March 7-9, 2013, in Tempe, Ariz.

NEW YORK—Hospitalists are poised to become key allies with hospital quality and safety officers nationwide, according to veteran hospitalist Jennifer Myers, MD, FHM, director of quality and safety education for Penn Medicine in Philadelphia.

Addressing hospitalists at the seventh annual Mid-Atlantic Hospital Medicine Symposium at Mount Sinai School of Medicine in New York, Dr. Myers said that while the challenges associated with quality improvement (QI) are many, HM leaders have the in-house relationships and respect to push the issue.

"There's really no other specialty more perfectly poised to lead this work," she told more than 180 symposium attendees Friday.

Dr. Myers, in an address titled "Enhancing Patient Safety," told The Hospitalist that HM leaders pursue three broad goals: to participate in QI programs already in place, to help create or foster a culture focused on addressing mistakes, and to teach those lessons to young physicians.

She urged physicians to actively report on mistakes and near misses, and earnestly address the processes that led to them. If a vehicle to discuss the mistakes doesn't exist at an institution, hospitalists can push to start one, she said. If a hospital doesn't have an electronic incident reporting system, a hospitalist can push to get one. "This is the goal," Dr. Myers added. "People coming to work and feeling they can be safe and report errors in the spirit of improvement."

She noted that many hospitalists already oversee quality and safety programs without any formal training. She recommended some of those physicians consider the Quality and Safety Educators Academy (QSEA), a three-day academy designed as a faculty development program and sponsored by SHM and the Alliance for Academic Internal Medicine (AAIM). The academy is March 7-9, 2013, in Tempe, Ariz.

Using localized inpatient teams of hospitalists and physician assistants in single nursing units can boost physicians' productivity, hospital efficiency, and patient outcomes, according to a study in the Journal of Hospital Medicine.

The study, "Impact of Localizing General Medical Teams to a Single Nursing Unit," compared the effectiveness of using localized medical teams with nonlocalized teams in caring for patients in the nursing unit of an academic medical center from April to mid-July 2010. The localized team members received 51% fewer paged messages, logged more encounters with patients, and generated more relative value units (RVUs) during the workday compared with the nonlocalized teams, researchers reported.

These findings point to an overall significant increase in team productivity. The risk of 30-day readmissions and the patient charges incurred remained the same.

Lead author Siddhartha Singh, MD, MS, associate chief medical officer at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee, says the study's most surprising finding was that patients averaged longer length of stay (LOS) under localized team care. However, Dr. Singh says, "if somebody wants to try out localization, the big message from our study is that it's a good thing as far as workflow is concerned."

Dr. Singh hopes the research will spark future studies about localized hospitalist teams and the optimal amount of localization needed to improve productivity and efficiency.

"When others try to localize patients, they need to be careful of 100% localization," he says. "My sense is, without having studied this any further, there's a sweet spot that optimizes the care provided to the patients [and maximizes] hospital efficiency and physician assistant productivity. I'm hoping that the next set of research on this topic tries to investigate that."

Using localized inpatient teams of hospitalists and physician assistants in single nursing units can boost physicians' productivity, hospital efficiency, and patient outcomes, according to a study in the Journal of Hospital Medicine.

The study, "Impact of Localizing General Medical Teams to a Single Nursing Unit," compared the effectiveness of using localized medical teams with nonlocalized teams in caring for patients in the nursing unit of an academic medical center from April to mid-July 2010. The localized team members received 51% fewer paged messages, logged more encounters with patients, and generated more relative value units (RVUs) during the workday compared with the nonlocalized teams, researchers reported.

These findings point to an overall significant increase in team productivity. The risk of 30-day readmissions and the patient charges incurred remained the same.

Lead author Siddhartha Singh, MD, MS, associate chief medical officer at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee, says the study's most surprising finding was that patients averaged longer length of stay (LOS) under localized team care. However, Dr. Singh says, "if somebody wants to try out localization, the big message from our study is that it's a good thing as far as workflow is concerned."

Dr. Singh hopes the research will spark future studies about localized hospitalist teams and the optimal amount of localization needed to improve productivity and efficiency.

"When others try to localize patients, they need to be careful of 100% localization," he says. "My sense is, without having studied this any further, there's a sweet spot that optimizes the care provided to the patients [and maximizes] hospital efficiency and physician assistant productivity. I'm hoping that the next set of research on this topic tries to investigate that."

Using localized inpatient teams of hospitalists and physician assistants in single nursing units can boost physicians' productivity, hospital efficiency, and patient outcomes, according to a study in the Journal of Hospital Medicine.

The study, "Impact of Localizing General Medical Teams to a Single Nursing Unit," compared the effectiveness of using localized medical teams with nonlocalized teams in caring for patients in the nursing unit of an academic medical center from April to mid-July 2010. The localized team members received 51% fewer paged messages, logged more encounters with patients, and generated more relative value units (RVUs) during the workday compared with the nonlocalized teams, researchers reported.

These findings point to an overall significant increase in team productivity. The risk of 30-day readmissions and the patient charges incurred remained the same.

Lead author Siddhartha Singh, MD, MS, associate chief medical officer at Froedtert Hospital and the Medical College of Wisconsin in Milwaukee, says the study's most surprising finding was that patients averaged longer length of stay (LOS) under localized team care. However, Dr. Singh says, "if somebody wants to try out localization, the big message from our study is that it's a good thing as far as workflow is concerned."

Dr. Singh hopes the research will spark future studies about localized hospitalist teams and the optimal amount of localization needed to improve productivity and efficiency.

"When others try to localize patients, they need to be careful of 100% localization," he says. "My sense is, without having studied this any further, there's a sweet spot that optimizes the care provided to the patients [and maximizes] hospital efficiency and physician assistant productivity. I'm hoping that the next set of research on this topic tries to investigate that."

Adalimumab, a subcutaneously administered tumor necrosis factor blocker, has been approved for treating adults with moderately to severely active ulcerative colitis who have not had an adequate response with conventional treatments, the Food and Drug Administration announced.

The safety and effectiveness of adalimumab for this patient population was established in two clinical studies of 908 patients with moderately to severely active ulcerative colitis (UC).

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved for treating rheumatoid arthritis in 2002, followed by psoriatic arthritis in 2005, ankylosing spondylitis in 2006, Crohn’s disease in 2007, and plaque psoriasis and juvenile idiopathic arthritis in 2008.

Adalimumab is the second TNF blocker to be approved for ulcerative colitis; infliximab (Remicade), an intravenous TNF blocker, was previously approved for treating ulcerative colitis.

Clinical remission rates in the two studies were significantly greater among patients treated with infliximab than among those who received placebo: In an 8-week study, which did not include patients who had previously been treated with a TNF blocker, the clinical remission rate at 8 weeks was 18.5% among those on adalimumab vs. 9.2% in those on placebo, a 9.3% difference.

In the second study, which followed patients for 1 year and included some who had been treated with infliximab, the clinical remission rate at 8 weeks was 16.5% among those on adalimumab, vs. 9.3% among those on placebo, a 7.2% difference.

At a meeting on Aug. 28 held to review these data, the majority of the FDA’s Gastrointestinal Drugs Advisory Committee agreed that these differences represented clinically meaningful benefits and supported approval of adalimumab for this indication – adults with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment.

Panelists cited the need for more treatments for ulcerative colitis and for a subcutaneous TNF blocker for these patients, as well as its potential steroid-sparing effects.

In the studies, no new side effects were identified, the agency said.

The FDA statement points out that the effectiveness of adalimumab "has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers."

The approved dosing regimen for adalimumab is a starting dose of 160 mg, followed by a second dose of 80 mg 2 weeks later and then a maintenance dose of 40 mg every other week.

"The drug should only continue to be used in patients who have shown evidence of clinical remission by 8 weeks of therapy," according to the FDA statement.

Adalimumab is the first self-administered biologic treatment for ulcerative colitis to be approved.

Adalimumab, a subcutaneously administered tumor necrosis factor blocker, has been approved for treating adults with moderately to severely active ulcerative colitis who have not had an adequate response with conventional treatments, the Food and Drug Administration announced.

The safety and effectiveness of adalimumab for this patient population was established in two clinical studies of 908 patients with moderately to severely active ulcerative colitis (UC).

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved for treating rheumatoid arthritis in 2002, followed by psoriatic arthritis in 2005, ankylosing spondylitis in 2006, Crohn’s disease in 2007, and plaque psoriasis and juvenile idiopathic arthritis in 2008.

Adalimumab is the second TNF blocker to be approved for ulcerative colitis; infliximab (Remicade), an intravenous TNF blocker, was previously approved for treating ulcerative colitis.

Clinical remission rates in the two studies were significantly greater among patients treated with infliximab than among those who received placebo: In an 8-week study, which did not include patients who had previously been treated with a TNF blocker, the clinical remission rate at 8 weeks was 18.5% among those on adalimumab vs. 9.2% in those on placebo, a 9.3% difference.

In the second study, which followed patients for 1 year and included some who had been treated with infliximab, the clinical remission rate at 8 weeks was 16.5% among those on adalimumab, vs. 9.3% among those on placebo, a 7.2% difference.

At a meeting on Aug. 28 held to review these data, the majority of the FDA’s Gastrointestinal Drugs Advisory Committee agreed that these differences represented clinically meaningful benefits and supported approval of adalimumab for this indication – adults with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment.

Panelists cited the need for more treatments for ulcerative colitis and for a subcutaneous TNF blocker for these patients, as well as its potential steroid-sparing effects.

In the studies, no new side effects were identified, the agency said.

The FDA statement points out that the effectiveness of adalimumab "has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers."

The approved dosing regimen for adalimumab is a starting dose of 160 mg, followed by a second dose of 80 mg 2 weeks later and then a maintenance dose of 40 mg every other week.

"The drug should only continue to be used in patients who have shown evidence of clinical remission by 8 weeks of therapy," according to the FDA statement.

Adalimumab is the first self-administered biologic treatment for ulcerative colitis to be approved.

Adalimumab, a subcutaneously administered tumor necrosis factor blocker, has been approved for treating adults with moderately to severely active ulcerative colitis who have not had an adequate response with conventional treatments, the Food and Drug Administration announced.

The safety and effectiveness of adalimumab for this patient population was established in two clinical studies of 908 patients with moderately to severely active ulcerative colitis (UC).

Adalimumab, marketed as Humira by Abbott Laboratories, was first approved for treating rheumatoid arthritis in 2002, followed by psoriatic arthritis in 2005, ankylosing spondylitis in 2006, Crohn’s disease in 2007, and plaque psoriasis and juvenile idiopathic arthritis in 2008.

Adalimumab is the second TNF blocker to be approved for ulcerative colitis; infliximab (Remicade), an intravenous TNF blocker, was previously approved for treating ulcerative colitis.

Clinical remission rates in the two studies were significantly greater among patients treated with infliximab than among those who received placebo: In an 8-week study, which did not include patients who had previously been treated with a TNF blocker, the clinical remission rate at 8 weeks was 18.5% among those on adalimumab vs. 9.2% in those on placebo, a 9.3% difference.

In the second study, which followed patients for 1 year and included some who had been treated with infliximab, the clinical remission rate at 8 weeks was 16.5% among those on adalimumab, vs. 9.3% among those on placebo, a 7.2% difference.

At a meeting on Aug. 28 held to review these data, the majority of the FDA’s Gastrointestinal Drugs Advisory Committee agreed that these differences represented clinically meaningful benefits and supported approval of adalimumab for this indication – adults with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment.

Panelists cited the need for more treatments for ulcerative colitis and for a subcutaneous TNF blocker for these patients, as well as its potential steroid-sparing effects.

In the studies, no new side effects were identified, the agency said.

The FDA statement points out that the effectiveness of adalimumab "has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers."

The approved dosing regimen for adalimumab is a starting dose of 160 mg, followed by a second dose of 80 mg 2 weeks later and then a maintenance dose of 40 mg every other week.

"The drug should only continue to be used in patients who have shown evidence of clinical remission by 8 weeks of therapy," according to the FDA statement.

Adalimumab is the first self-administered biologic treatment for ulcerative colitis to be approved.

Ustekinumab induced a clinical response in patients with moderate to severe Crohn’s disease that was resistant to tumor necrosis factor antagonists, in a phase IIb clinical trial published online Oct. 17 in the New England Journal of Medicine.

However, the agent did not improve remission rates, compared with placebo, said Dr. William J. Sandborn, AGAF, who is professor of medicine and chief of the division of gastroenterology at the University of California San Diego, La Jolla, and his associates.

"A sizable proportion" of patients with moderate to severe Crohn’s disease do not respond to TNF antagonists, have an unsustained response, or must discontinue the medications because of adverse effects. After ustekinumab showed efficacy in such patients in a phase IIa clinical study, Dr. Sandborn and his colleagues performed a 36-week double-blind phase IIb trial in 526 adults at 153 medical centers in 12 countries.

Ustekinumab, a human IgG monoclonal antibody that inhibits the receptors for interleukin-12 and interleukin-23 on T cells, natural killer cells, and antigen-presenting cells, has Food and Drug Administration approval for use in plaque psoriasis. This clinical trial was sponsored by an affiliate of the manufacturer, Janssen Biotech.

During an 8-week induction phase, the study subjects were randomly assigned to receive intravenous placebo (132 patients) or ustekinumab in 1-mg/kg (131 patients), 3-mg/kg (132 patients), or 6-mg/kg (131 patients) doses. Then, during weeks 8-36, the study subjects who showed a response to induction therapy and those who did not show a response were separately randomized to receive either subcutaneous ustekinumab (90 mg) or placebo at week 8 and week 16, as maintenance therapy.

Treatment efficacy was assessed at week 22, and patients were followed through week 36 for a safety analysis. A total of 36.1% of the subjects discontinued the study before week 36.

The primary end point was a clinical response, defined as a decrease of 100 points or more on the Crohn’s Disease Activity Index (CDAI) score.

A total of 39.7% of patients receiving the 6-mg induction dose showed a clinical response, which was significantly greater than the 23.5% of patients receiving placebo, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1203572]).

A greater number of patients receiving the lower doses of ustekinumab than receiving placebo showed a clinical response, but the differences between these low-dose groups and the placebo group did not reach statistical significance.

The 6-mg/kg dose was effective across most demographic and disease characteristics, judging from the findings of a subgroup analysis. It was consistently effective in patients who had failed on their first attempt at therapy with TNF antagonists, patients who had failed on two or more TNF antagonists, and patients who had only a transient response to TNF antagonists.

However, rates of clinical remission did not differ significantly between patients receiving ustekinumab and those receiving placebo, Dr. Sandborn and his associates said.

At all follow-up visits, the proportion of patients who had a 70-point clinical response was significantly higher, the reductions in mean CDAI scores were significantly greater, and the reductions in C-reactive protein levels were significantly greater in patients receiving 6 mg per kg of ustekinumab than in the placebo group.

As a maintenance therapy, 90 mg of subcutaneous ustekinumab appeared to be effective in patients who responded to the induction dose of the agent. The proportion of patients who showed a clinical response at week 22 was 69.4% in those receiving maintenance ustekinumab, significantly greater than the 42.5% response rate among those receiving maintenance placebo.

Among patients who responded to induction-phase ustekinumab, 41.7% of those who also received maintenance ustekinumab achieved clinical remission at week 22, compared with only 27.4% of those who received maintenance placebo.

Similarly, among patients who showed a response to induction ustekinumab, reductions in both CDAI scores and CRP levels were sustained if they continued on maintenance ustekinumab but were not sustained if they continued on placebo for the maintenance period.

However, patients who did not show a response to induction ustekinumab also did not benefit from additional ustekinumab in the maintenance phase of the study.

The results of the safety analysis were "somewhat limited" by the small sample size and the short duration of treatment. No deaths, serious opportunistic infections, or major adverse cardiovascular events were reported, "but large studies of longer duration are needed to assess uncommon adverse events," the investigators said.

Of note, one patient receiving ustekinumab as both induction and maintenance therapy developed a basal cell carcinoma. Among patients taking ustekinumab in the induction phase of the study, six developed serious infections: Clostridium difficile, viral gastroenteritis, UTI, anal abscess, vaginal abscess, and a staph infection of a central catheter.

Ustekinumab induced a clinical response in patients with moderate to severe Crohn’s disease that was resistant to tumor necrosis factor antagonists, in a phase IIb clinical trial published online Oct. 17 in the New England Journal of Medicine.

However, the agent did not improve remission rates, compared with placebo, said Dr. William J. Sandborn, AGAF, who is professor of medicine and chief of the division of gastroenterology at the University of California San Diego, La Jolla, and his associates.

"A sizable proportion" of patients with moderate to severe Crohn’s disease do not respond to TNF antagonists, have an unsustained response, or must discontinue the medications because of adverse effects. After ustekinumab showed efficacy in such patients in a phase IIa clinical study, Dr. Sandborn and his colleagues performed a 36-week double-blind phase IIb trial in 526 adults at 153 medical centers in 12 countries.

Ustekinumab, a human IgG monoclonal antibody that inhibits the receptors for interleukin-12 and interleukin-23 on T cells, natural killer cells, and antigen-presenting cells, has Food and Drug Administration approval for use in plaque psoriasis. This clinical trial was sponsored by an affiliate of the manufacturer, Janssen Biotech.

During an 8-week induction phase, the study subjects were randomly assigned to receive intravenous placebo (132 patients) or ustekinumab in 1-mg/kg (131 patients), 3-mg/kg (132 patients), or 6-mg/kg (131 patients) doses. Then, during weeks 8-36, the study subjects who showed a response to induction therapy and those who did not show a response were separately randomized to receive either subcutaneous ustekinumab (90 mg) or placebo at week 8 and week 16, as maintenance therapy.

Treatment efficacy was assessed at week 22, and patients were followed through week 36 for a safety analysis. A total of 36.1% of the subjects discontinued the study before week 36.

The primary end point was a clinical response, defined as a decrease of 100 points or more on the Crohn’s Disease Activity Index (CDAI) score.

A total of 39.7% of patients receiving the 6-mg induction dose showed a clinical response, which was significantly greater than the 23.5% of patients receiving placebo, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1203572]).

A greater number of patients receiving the lower doses of ustekinumab than receiving placebo showed a clinical response, but the differences between these low-dose groups and the placebo group did not reach statistical significance.

The 6-mg/kg dose was effective across most demographic and disease characteristics, judging from the findings of a subgroup analysis. It was consistently effective in patients who had failed on their first attempt at therapy with TNF antagonists, patients who had failed on two or more TNF antagonists, and patients who had only a transient response to TNF antagonists.

However, rates of clinical remission did not differ significantly between patients receiving ustekinumab and those receiving placebo, Dr. Sandborn and his associates said.

At all follow-up visits, the proportion of patients who had a 70-point clinical response was significantly higher, the reductions in mean CDAI scores were significantly greater, and the reductions in C-reactive protein levels were significantly greater in patients receiving 6 mg per kg of ustekinumab than in the placebo group.

As a maintenance therapy, 90 mg of subcutaneous ustekinumab appeared to be effective in patients who responded to the induction dose of the agent. The proportion of patients who showed a clinical response at week 22 was 69.4% in those receiving maintenance ustekinumab, significantly greater than the 42.5% response rate among those receiving maintenance placebo.

Among patients who responded to induction-phase ustekinumab, 41.7% of those who also received maintenance ustekinumab achieved clinical remission at week 22, compared with only 27.4% of those who received maintenance placebo.

Similarly, among patients who showed a response to induction ustekinumab, reductions in both CDAI scores and CRP levels were sustained if they continued on maintenance ustekinumab but were not sustained if they continued on placebo for the maintenance period.

However, patients who did not show a response to induction ustekinumab also did not benefit from additional ustekinumab in the maintenance phase of the study.

The results of the safety analysis were "somewhat limited" by the small sample size and the short duration of treatment. No deaths, serious opportunistic infections, or major adverse cardiovascular events were reported, "but large studies of longer duration are needed to assess uncommon adverse events," the investigators said.

Of note, one patient receiving ustekinumab as both induction and maintenance therapy developed a basal cell carcinoma. Among patients taking ustekinumab in the induction phase of the study, six developed serious infections: Clostridium difficile, viral gastroenteritis, UTI, anal abscess, vaginal abscess, and a staph infection of a central catheter.

Ustekinumab induced a clinical response in patients with moderate to severe Crohn’s disease that was resistant to tumor necrosis factor antagonists, in a phase IIb clinical trial published online Oct. 17 in the New England Journal of Medicine.

However, the agent did not improve remission rates, compared with placebo, said Dr. William J. Sandborn, AGAF, who is professor of medicine and chief of the division of gastroenterology at the University of California San Diego, La Jolla, and his associates.

"A sizable proportion" of patients with moderate to severe Crohn’s disease do not respond to TNF antagonists, have an unsustained response, or must discontinue the medications because of adverse effects. After ustekinumab showed efficacy in such patients in a phase IIa clinical study, Dr. Sandborn and his colleagues performed a 36-week double-blind phase IIb trial in 526 adults at 153 medical centers in 12 countries.

Ustekinumab, a human IgG monoclonal antibody that inhibits the receptors for interleukin-12 and interleukin-23 on T cells, natural killer cells, and antigen-presenting cells, has Food and Drug Administration approval for use in plaque psoriasis. This clinical trial was sponsored by an affiliate of the manufacturer, Janssen Biotech.

During an 8-week induction phase, the study subjects were randomly assigned to receive intravenous placebo (132 patients) or ustekinumab in 1-mg/kg (131 patients), 3-mg/kg (132 patients), or 6-mg/kg (131 patients) doses. Then, during weeks 8-36, the study subjects who showed a response to induction therapy and those who did not show a response were separately randomized to receive either subcutaneous ustekinumab (90 mg) or placebo at week 8 and week 16, as maintenance therapy.

Treatment efficacy was assessed at week 22, and patients were followed through week 36 for a safety analysis. A total of 36.1% of the subjects discontinued the study before week 36.

The primary end point was a clinical response, defined as a decrease of 100 points or more on the Crohn’s Disease Activity Index (CDAI) score.

A total of 39.7% of patients receiving the 6-mg induction dose showed a clinical response, which was significantly greater than the 23.5% of patients receiving placebo, the investigators said (N. Engl. J. Med. 2012 [doi:10.1056/NEJMoa1203572]).

A greater number of patients receiving the lower doses of ustekinumab than receiving placebo showed a clinical response, but the differences between these low-dose groups and the placebo group did not reach statistical significance.

The 6-mg/kg dose was effective across most demographic and disease characteristics, judging from the findings of a subgroup analysis. It was consistently effective in patients who had failed on their first attempt at therapy with TNF antagonists, patients who had failed on two or more TNF antagonists, and patients who had only a transient response to TNF antagonists.

However, rates of clinical remission did not differ significantly between patients receiving ustekinumab and those receiving placebo, Dr. Sandborn and his associates said.

At all follow-up visits, the proportion of patients who had a 70-point clinical response was significantly higher, the reductions in mean CDAI scores were significantly greater, and the reductions in C-reactive protein levels were significantly greater in patients receiving 6 mg per kg of ustekinumab than in the placebo group.

As a maintenance therapy, 90 mg of subcutaneous ustekinumab appeared to be effective in patients who responded to the induction dose of the agent. The proportion of patients who showed a clinical response at week 22 was 69.4% in those receiving maintenance ustekinumab, significantly greater than the 42.5% response rate among those receiving maintenance placebo.

Among patients who responded to induction-phase ustekinumab, 41.7% of those who also received maintenance ustekinumab achieved clinical remission at week 22, compared with only 27.4% of those who received maintenance placebo.

Similarly, among patients who showed a response to induction ustekinumab, reductions in both CDAI scores and CRP levels were sustained if they continued on maintenance ustekinumab but were not sustained if they continued on placebo for the maintenance period.

However, patients who did not show a response to induction ustekinumab also did not benefit from additional ustekinumab in the maintenance phase of the study.

The results of the safety analysis were "somewhat limited" by the small sample size and the short duration of treatment. No deaths, serious opportunistic infections, or major adverse cardiovascular events were reported, "but large studies of longer duration are needed to assess uncommon adverse events," the investigators said.

Of note, one patient receiving ustekinumab as both induction and maintenance therapy developed a basal cell carcinoma. Among patients taking ustekinumab in the induction phase of the study, six developed serious infections: Clostridium difficile, viral gastroenteritis, UTI, anal abscess, vaginal abscess, and a staph infection of a central catheter.

Rapid diagnostic and point-of-care tests for hepatitis C virus are accurate enough to be used in first-line HCV screening worldwide, according to results from the first systematic review of evidence on such tests.

Blood-based point-of-care tests (POCTs) had better sensitivity and specificity overall than did blood-based rapid diagnostic tests (RDTs), Sushmita Shivkumar of McGill University, Montreal, Quebec, and her colleagues reported.

POCTs do not require sample processing or refrigeration, and have a shelf life of 6 months or more. Rapid diagnostic tests, or RDTs, require refrigeration and sample processing. Manufactured by a variety of firms under various marketing names, all the tests can detect HCV infection in under 30 minutes, with many taking less than 5 minutes, according to the investigators, who conducted a meta-analysis of 18 studies evaluating the accuracy of one or more RDT or POCT, compared with standard assays (Ann. Intern. Med. 2012;157:558-66).

Ms. Shivkumar and her colleagues found blood-based POCTs (using serum, plasma, or whole blood) to be the most accurate of the tests evaluated in the included studies, showing 98.9% sensitivity with a 95% confidence interval [CI] of 94.5%-99.8% for whole blood and 96.8%-99.6% for serum or plasma). RDTs of serum or plasma had 98.4% sensitivity (95% CI 88.9%-99.8%). Specificity was highest in POCTs of serum or plasma at 99.7% (95% CI, 99.3%-99.9%), followed by POCTs of whole blood at 99.5% (95% CI, 97.5%-99.9%), RDTs of serum or plasma at 98.6% (95% CI, 94.9%-99.6%). POCTs for oral fluids had a sensitivity of 97.1% (95% CI, 94.7%-98.4%) and specificity of 98.2% (95% CI, 92.2%-99.6%).

POCTs and RDTs cannot distinguish between acute and chronic HCV infections, which is one of the reasons that public health organizations continue to favor conventional assays. The Food and Drug Administration currently approves the use of a single POCT for HCV, and for use only in nontraditional settings; in the United Kingdom and Canada such tests have not yet been approved.

However, by being fast, accurate, and cheaper than conventional tests, the rapid diagnostic and point-of-care tests offer "great potential for expanded first-line screening for hepatitis C infection and demonstrate the utility of blood-based singleton POCTs and of multiplex POCTs designed to provide integrated HIV and HCV screening of at-risk populations," Ms. Shivkumar and her associates wrote in their analysis. "Their rapid turnaround time limits loss to follow-up and facilitates early linkages."

The authors also concluded that their findings showed that the rapid and point-of-care tests could play a "substantial role" in expanded global screening initiatives for HCV.

The blood-based POCTs, besides being the most accurate, have the advantage of not requiring refrigeration, the investigators wrote. This feature is key in developing countries in Africa and Asia, where prevalence of HCV infection is highest.

Ms. Shivkumar and her colleagues noted several weaknesses in their meta-analysis, mostly related to the quality of studies included. Only three of the studies they evaluated were blinded, while four received industry funding; the conventional assays used as reference varied in the studies, and HCV genotype information was not collected in most.

The study was supported by grants from the Canadian Institutes of Health Research. None of the authors declared conflicts of interest.

Rapid diagnostic and point-of-care tests for hepatitis C virus are accurate enough to be used in first-line HCV screening worldwide, according to results from the first systematic review of evidence on such tests.

Blood-based point-of-care tests (POCTs) had better sensitivity and specificity overall than did blood-based rapid diagnostic tests (RDTs), Sushmita Shivkumar of McGill University, Montreal, Quebec, and her colleagues reported.

POCTs do not require sample processing or refrigeration, and have a shelf life of 6 months or more. Rapid diagnostic tests, or RDTs, require refrigeration and sample processing. Manufactured by a variety of firms under various marketing names, all the tests can detect HCV infection in under 30 minutes, with many taking less than 5 minutes, according to the investigators, who conducted a meta-analysis of 18 studies evaluating the accuracy of one or more RDT or POCT, compared with standard assays (Ann. Intern. Med. 2012;157:558-66).

Ms. Shivkumar and her colleagues found blood-based POCTs (using serum, plasma, or whole blood) to be the most accurate of the tests evaluated in the included studies, showing 98.9% sensitivity with a 95% confidence interval [CI] of 94.5%-99.8% for whole blood and 96.8%-99.6% for serum or plasma). RDTs of serum or plasma had 98.4% sensitivity (95% CI 88.9%-99.8%). Specificity was highest in POCTs of serum or plasma at 99.7% (95% CI, 99.3%-99.9%), followed by POCTs of whole blood at 99.5% (95% CI, 97.5%-99.9%), RDTs of serum or plasma at 98.6% (95% CI, 94.9%-99.6%). POCTs for oral fluids had a sensitivity of 97.1% (95% CI, 94.7%-98.4%) and specificity of 98.2% (95% CI, 92.2%-99.6%).

POCTs and RDTs cannot distinguish between acute and chronic HCV infections, which is one of the reasons that public health organizations continue to favor conventional assays. The Food and Drug Administration currently approves the use of a single POCT for HCV, and for use only in nontraditional settings; in the United Kingdom and Canada such tests have not yet been approved.

However, by being fast, accurate, and cheaper than conventional tests, the rapid diagnostic and point-of-care tests offer "great potential for expanded first-line screening for hepatitis C infection and demonstrate the utility of blood-based singleton POCTs and of multiplex POCTs designed to provide integrated HIV and HCV screening of at-risk populations," Ms. Shivkumar and her associates wrote in their analysis. "Their rapid turnaround time limits loss to follow-up and facilitates early linkages."

The authors also concluded that their findings showed that the rapid and point-of-care tests could play a "substantial role" in expanded global screening initiatives for HCV.

The blood-based POCTs, besides being the most accurate, have the advantage of not requiring refrigeration, the investigators wrote. This feature is key in developing countries in Africa and Asia, where prevalence of HCV infection is highest.

Ms. Shivkumar and her colleagues noted several weaknesses in their meta-analysis, mostly related to the quality of studies included. Only three of the studies they evaluated were blinded, while four received industry funding; the conventional assays used as reference varied in the studies, and HCV genotype information was not collected in most.

The study was supported by grants from the Canadian Institutes of Health Research. None of the authors declared conflicts of interest.

Rapid diagnostic and point-of-care tests for hepatitis C virus are accurate enough to be used in first-line HCV screening worldwide, according to results from the first systematic review of evidence on such tests.

Blood-based point-of-care tests (POCTs) had better sensitivity and specificity overall than did blood-based rapid diagnostic tests (RDTs), Sushmita Shivkumar of McGill University, Montreal, Quebec, and her colleagues reported.

POCTs do not require sample processing or refrigeration, and have a shelf life of 6 months or more. Rapid diagnostic tests, or RDTs, require refrigeration and sample processing. Manufactured by a variety of firms under various marketing names, all the tests can detect HCV infection in under 30 minutes, with many taking less than 5 minutes, according to the investigators, who conducted a meta-analysis of 18 studies evaluating the accuracy of one or more RDT or POCT, compared with standard assays (Ann. Intern. Med. 2012;157:558-66).

Ms. Shivkumar and her colleagues found blood-based POCTs (using serum, plasma, or whole blood) to be the most accurate of the tests evaluated in the included studies, showing 98.9% sensitivity with a 95% confidence interval [CI] of 94.5%-99.8% for whole blood and 96.8%-99.6% for serum or plasma). RDTs of serum or plasma had 98.4% sensitivity (95% CI 88.9%-99.8%). Specificity was highest in POCTs of serum or plasma at 99.7% (95% CI, 99.3%-99.9%), followed by POCTs of whole blood at 99.5% (95% CI, 97.5%-99.9%), RDTs of serum or plasma at 98.6% (95% CI, 94.9%-99.6%). POCTs for oral fluids had a sensitivity of 97.1% (95% CI, 94.7%-98.4%) and specificity of 98.2% (95% CI, 92.2%-99.6%).

POCTs and RDTs cannot distinguish between acute and chronic HCV infections, which is one of the reasons that public health organizations continue to favor conventional assays. The Food and Drug Administration currently approves the use of a single POCT for HCV, and for use only in nontraditional settings; in the United Kingdom and Canada such tests have not yet been approved.

However, by being fast, accurate, and cheaper than conventional tests, the rapid diagnostic and point-of-care tests offer "great potential for expanded first-line screening for hepatitis C infection and demonstrate the utility of blood-based singleton POCTs and of multiplex POCTs designed to provide integrated HIV and HCV screening of at-risk populations," Ms. Shivkumar and her associates wrote in their analysis. "Their rapid turnaround time limits loss to follow-up and facilitates early linkages."

The authors also concluded that their findings showed that the rapid and point-of-care tests could play a "substantial role" in expanded global screening initiatives for HCV.

The blood-based POCTs, besides being the most accurate, have the advantage of not requiring refrigeration, the investigators wrote. This feature is key in developing countries in Africa and Asia, where prevalence of HCV infection is highest.

Ms. Shivkumar and her colleagues noted several weaknesses in their meta-analysis, mostly related to the quality of studies included. Only three of the studies they evaluated were blinded, while four received industry funding; the conventional assays used as reference varied in the studies, and HCV genotype information was not collected in most.

The study was supported by grants from the Canadian Institutes of Health Research. None of the authors declared conflicts of interest.

I had a thought experiment based on two truths about myself: I am all for universal health care, and I would not have strong objections to receiving a fixed salary.

But I know a lot of doctors who oppose Obamacare. I can see how having to see more patients and accept lower reimbursement rates, all while filling out disability paperwork for people you believe actually do have the capacity to work might leave a bad taste in any doctor’s mouth.

So here is the thought experiment: In this increasingly interdependent world, what if we could open up licensing regulations for physicians that would allow those of us who favor universal health care to practice in Canada or other parts of the United Kingdom, for example, and those who believe in traditional insurance-based health care to practice in the United States?

Wouldn’t that be ideal? Win-win.

I thought about the lung cancer patient in Wales whose surgery, radiation, and chemotherapy were all paid for by the National Health Service. Were he to develop metastatic disease, the NHS would not pay for Tarceva (erlotinib), because the National Institute for Health and Clinical Excellence (NICE) has decided that the cost of the drug is not worth the 8 extra weeks that the patient gets.

To some, this is the very definition of fairness. Health care is universal and is paid for by taxes. What is deemed reasonable is given to you completely free, and what is not, well, isn’t. It seems to be a more thoughtful, compassionate, and just way to practice medicine, and perhaps more practical as well. Everyone gets standard of care.

For others, the above scenario is inherently unfair. Why should a government agency decide what will be good for the individual? Why should government decide that an extra 8 weeks for any individual is futile and not worth taxpayer money? People should be able to buy what they can afford, regardless of outcome. It is their money after all.

And then I realized that it is in such societies where capitalism is unbridled that pharmaceuticals thrive. Capitalism provides pharmaceutical companies with the incentives to invest in research and development. And it is precisely that R&D that leads to the kind of information that NICE needs to make decisions about drug utilization.

Said another way, the information and innovation that come from cutthroat capitalist societies is precisely what allows the nationalized health care systems to succeed.

So while I may dislike the unabashed concern for profit that I imagine motivates health insurance agencies and pharmaceutical companies (who among us, left or right leaning, didn’t find the increase in colchicine pricing offensive?), I recognize their necessity and am ultimately grateful that what they do allows societies that do provide universal health care to do so.

Bonus: Interestingly enough, I found a paper from the economics department at MIT that says basically the same thing, not just about health care, but about welfare in general.

Dr. Chan practices rheumatology in Pawtucket, R.I.

I had a thought experiment based on two truths about myself: I am all for universal health care, and I would not have strong objections to receiving a fixed salary.

But I know a lot of doctors who oppose Obamacare. I can see how having to see more patients and accept lower reimbursement rates, all while filling out disability paperwork for people you believe actually do have the capacity to work might leave a bad taste in any doctor’s mouth.

So here is the thought experiment: In this increasingly interdependent world, what if we could open up licensing regulations for physicians that would allow those of us who favor universal health care to practice in Canada or other parts of the United Kingdom, for example, and those who believe in traditional insurance-based health care to practice in the United States?

Wouldn’t that be ideal? Win-win.

I thought about the lung cancer patient in Wales whose surgery, radiation, and chemotherapy were all paid for by the National Health Service. Were he to develop metastatic disease, the NHS would not pay for Tarceva (erlotinib), because the National Institute for Health and Clinical Excellence (NICE) has decided that the cost of the drug is not worth the 8 extra weeks that the patient gets.

To some, this is the very definition of fairness. Health care is universal and is paid for by taxes. What is deemed reasonable is given to you completely free, and what is not, well, isn’t. It seems to be a more thoughtful, compassionate, and just way to practice medicine, and perhaps more practical as well. Everyone gets standard of care.

For others, the above scenario is inherently unfair. Why should a government agency decide what will be good for the individual? Why should government decide that an extra 8 weeks for any individual is futile and not worth taxpayer money? People should be able to buy what they can afford, regardless of outcome. It is their money after all.

And then I realized that it is in such societies where capitalism is unbridled that pharmaceuticals thrive. Capitalism provides pharmaceutical companies with the incentives to invest in research and development. And it is precisely that R&D that leads to the kind of information that NICE needs to make decisions about drug utilization.

Said another way, the information and innovation that come from cutthroat capitalist societies is precisely what allows the nationalized health care systems to succeed.

So while I may dislike the unabashed concern for profit that I imagine motivates health insurance agencies and pharmaceutical companies (who among us, left or right leaning, didn’t find the increase in colchicine pricing offensive?), I recognize their necessity and am ultimately grateful that what they do allows societies that do provide universal health care to do so.

Bonus: Interestingly enough, I found a paper from the economics department at MIT that says basically the same thing, not just about health care, but about welfare in general.

Dr. Chan practices rheumatology in Pawtucket, R.I.

I had a thought experiment based on two truths about myself: I am all for universal health care, and I would not have strong objections to receiving a fixed salary.

But I know a lot of doctors who oppose Obamacare. I can see how having to see more patients and accept lower reimbursement rates, all while filling out disability paperwork for people you believe actually do have the capacity to work might leave a bad taste in any doctor’s mouth.

So here is the thought experiment: In this increasingly interdependent world, what if we could open up licensing regulations for physicians that would allow those of us who favor universal health care to practice in Canada or other parts of the United Kingdom, for example, and those who believe in traditional insurance-based health care to practice in the United States?

Wouldn’t that be ideal? Win-win.

I thought about the lung cancer patient in Wales whose surgery, radiation, and chemotherapy were all paid for by the National Health Service. Were he to develop metastatic disease, the NHS would not pay for Tarceva (erlotinib), because the National Institute for Health and Clinical Excellence (NICE) has decided that the cost of the drug is not worth the 8 extra weeks that the patient gets.

To some, this is the very definition of fairness. Health care is universal and is paid for by taxes. What is deemed reasonable is given to you completely free, and what is not, well, isn’t. It seems to be a more thoughtful, compassionate, and just way to practice medicine, and perhaps more practical as well. Everyone gets standard of care.

For others, the above scenario is inherently unfair. Why should a government agency decide what will be good for the individual? Why should government decide that an extra 8 weeks for any individual is futile and not worth taxpayer money? People should be able to buy what they can afford, regardless of outcome. It is their money after all.

And then I realized that it is in such societies where capitalism is unbridled that pharmaceuticals thrive. Capitalism provides pharmaceutical companies with the incentives to invest in research and development. And it is precisely that R&D that leads to the kind of information that NICE needs to make decisions about drug utilization.

Said another way, the information and innovation that come from cutthroat capitalist societies is precisely what allows the nationalized health care systems to succeed.

So while I may dislike the unabashed concern for profit that I imagine motivates health insurance agencies and pharmaceutical companies (who among us, left or right leaning, didn’t find the increase in colchicine pricing offensive?), I recognize their necessity and am ultimately grateful that what they do allows societies that do provide universal health care to do so.

Bonus: Interestingly enough, I found a paper from the economics department at MIT that says basically the same thing, not just about health care, but about welfare in general.

Dr. Chan practices rheumatology in Pawtucket, R.I.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2), as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, with recommendations to follow the drug’s long-term safety, at a meeting on Oct. 16.

At a meeting in September, the FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). In phase III studies of 169 adults with SBS, whose estimated small bowel length was a mean of 72 cm and who had been on parenteral nutrition and IV therapy for a mean of 7 years, teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo.

While the panelists unanimously agreed that the results represented a clinically meaningful benefit for these patients and generally felt comfortable with the drug’s safety profile, they recommended that more safety data are needed, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the distal small intestine and proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide, administered subcutaneously once a week, had evidence of increased villus height after 21 days of treatment, according to the company.

In the main phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. The volume of parenteral nutrition and IV fluids from baseline to the 24th week of treatment was reduced by a median of 4.4 L/week among patients on teduglutide, compared with 2.3 L/week for patients on placebo. Teduglutide treatment also led to a higher percentage of patients with at least one day less on therapy than did placebo (54% vs. 23%). An extension study indicated that this effect was maintained through 1 year of treatment.

While the FDA reviewers agreed that the drug had clinically meaningful effects in the studies, they raised some safety issues, mainly potential tumor-promoting effects, as well as potential GI side effects that included biliary and pancreatic disease and GI stenosis and obstruction. To date, there have been no reports of small bowel malignancies in treated patients; the three malignancies reported in treated patients have been a metastatic adenocarcinoma in a patient who had been on treatment for almost a year and lung cancer in two patients who had a history of smoking. Adenomas were seen in the bile duct and jejunum of rats at 700 times the human dose, findings that are "consistent with the pharmacological effects of the drug," according to the FDA.

There was also a low incidence of intestinal obstruction and stenosis, cholecystitis, and pancreatic disease in treated patients, compared with no cases among those on placebo.

NPS has proposed a registry of treated patients to evaluate the long-term safety and effectiveness of teduglutide, and a risk evaluation and mitigation strategy (REMS) aimed at educating prescribers about the potential and known risks of treatment. The REMS would include a letter to health care professionals and professional societies, including the American Gastroenterological Association and the American College of Gastroenterology; and drug labeling that includes contraindications in patients with a history of malignancy or with active or currently suspected malignancy, as well as warnings and precautions about the possible acceleration of neoplastic growth, colorectal polyps, and small bowel neoplasia.

The panel voted 10 to 1, with one abstention, that the company’s plans were adequate for addressing the safety concerns, although they pointed out that the number of patients in the studies was small and recommended close follow-up of treated patients.

"It seems like it’s a fairly safe drug," but follow-up is short term and fewer than 200 patients have been treated with teduglutide, said panelist Dr. Kevin Kelly, director of the division of solid tumor oncology at Thomas Jefferson University, Philadelphia. He and others recommended that patients be followed for up to 10 years.

"My gut feeling is that this is probably a very safe drug" that does not increase the risk of carcinogenesis, said another panelist, Dr. Ronald Fogel of the Digestive Health Center of Michigan in Chesterfield. He recommended more aggressive follow-up of treated patients than was proposed by the company, which he said could include serial colonoscopies at 2-year intervals with multiple biopsies at areas of dysplasia.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for people with SBS who are dependent on parenteral nutrition are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2), as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, with recommendations to follow the drug’s long-term safety, at a meeting on Oct. 16.

At a meeting in September, the FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). In phase III studies of 169 adults with SBS, whose estimated small bowel length was a mean of 72 cm and who had been on parenteral nutrition and IV therapy for a mean of 7 years, teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo.

While the panelists unanimously agreed that the results represented a clinically meaningful benefit for these patients and generally felt comfortable with the drug’s safety profile, they recommended that more safety data are needed, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the distal small intestine and proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide, administered subcutaneously once a week, had evidence of increased villus height after 21 days of treatment, according to the company.

In the main phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. The volume of parenteral nutrition and IV fluids from baseline to the 24th week of treatment was reduced by a median of 4.4 L/week among patients on teduglutide, compared with 2.3 L/week for patients on placebo. Teduglutide treatment also led to a higher percentage of patients with at least one day less on therapy than did placebo (54% vs. 23%). An extension study indicated that this effect was maintained through 1 year of treatment.

While the FDA reviewers agreed that the drug had clinically meaningful effects in the studies, they raised some safety issues, mainly potential tumor-promoting effects, as well as potential GI side effects that included biliary and pancreatic disease and GI stenosis and obstruction. To date, there have been no reports of small bowel malignancies in treated patients; the three malignancies reported in treated patients have been a metastatic adenocarcinoma in a patient who had been on treatment for almost a year and lung cancer in two patients who had a history of smoking. Adenomas were seen in the bile duct and jejunum of rats at 700 times the human dose, findings that are "consistent with the pharmacological effects of the drug," according to the FDA.

There was also a low incidence of intestinal obstruction and stenosis, cholecystitis, and pancreatic disease in treated patients, compared with no cases among those on placebo.

NPS has proposed a registry of treated patients to evaluate the long-term safety and effectiveness of teduglutide, and a risk evaluation and mitigation strategy (REMS) aimed at educating prescribers about the potential and known risks of treatment. The REMS would include a letter to health care professionals and professional societies, including the American Gastroenterological Association and the American College of Gastroenterology; and drug labeling that includes contraindications in patients with a history of malignancy or with active or currently suspected malignancy, as well as warnings and precautions about the possible acceleration of neoplastic growth, colorectal polyps, and small bowel neoplasia.

The panel voted 10 to 1, with one abstention, that the company’s plans were adequate for addressing the safety concerns, although they pointed out that the number of patients in the studies was small and recommended close follow-up of treated patients.

"It seems like it’s a fairly safe drug," but follow-up is short term and fewer than 200 patients have been treated with teduglutide, said panelist Dr. Kevin Kelly, director of the division of solid tumor oncology at Thomas Jefferson University, Philadelphia. He and others recommended that patients be followed for up to 10 years.

"My gut feeling is that this is probably a very safe drug" that does not increase the risk of carcinogenesis, said another panelist, Dr. Ronald Fogel of the Digestive Health Center of Michigan in Chesterfield. He recommended more aggressive follow-up of treated patients than was proposed by the company, which he said could include serial colonoscopies at 2-year intervals with multiple biopsies at areas of dysplasia.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for people with SBS who are dependent on parenteral nutrition are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2), as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, with recommendations to follow the drug’s long-term safety, at a meeting on Oct. 16.

At a meeting in September, the FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). In phase III studies of 169 adults with SBS, whose estimated small bowel length was a mean of 72 cm and who had been on parenteral nutrition and IV therapy for a mean of 7 years, teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo.

While the panelists unanimously agreed that the results represented a clinically meaningful benefit for these patients and generally felt comfortable with the drug’s safety profile, they recommended that more safety data are needed, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the distal small intestine and proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide, administered subcutaneously once a week, had evidence of increased villus height after 21 days of treatment, according to the company.

In the main phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. The volume of parenteral nutrition and IV fluids from baseline to the 24th week of treatment was reduced by a median of 4.4 L/week among patients on teduglutide, compared with 2.3 L/week for patients on placebo. Teduglutide treatment also led to a higher percentage of patients with at least one day less on therapy than did placebo (54% vs. 23%). An extension study indicated that this effect was maintained through 1 year of treatment.

While the FDA reviewers agreed that the drug had clinically meaningful effects in the studies, they raised some safety issues, mainly potential tumor-promoting effects, as well as potential GI side effects that included biliary and pancreatic disease and GI stenosis and obstruction. To date, there have been no reports of small bowel malignancies in treated patients; the three malignancies reported in treated patients have been a metastatic adenocarcinoma in a patient who had been on treatment for almost a year and lung cancer in two patients who had a history of smoking. Adenomas were seen in the bile duct and jejunum of rats at 700 times the human dose, findings that are "consistent with the pharmacological effects of the drug," according to the FDA.

There was also a low incidence of intestinal obstruction and stenosis, cholecystitis, and pancreatic disease in treated patients, compared with no cases among those on placebo.

NPS has proposed a registry of treated patients to evaluate the long-term safety and effectiveness of teduglutide, and a risk evaluation and mitigation strategy (REMS) aimed at educating prescribers about the potential and known risks of treatment. The REMS would include a letter to health care professionals and professional societies, including the American Gastroenterological Association and the American College of Gastroenterology; and drug labeling that includes contraindications in patients with a history of malignancy or with active or currently suspected malignancy, as well as warnings and precautions about the possible acceleration of neoplastic growth, colorectal polyps, and small bowel neoplasia.

The panel voted 10 to 1, with one abstention, that the company’s plans were adequate for addressing the safety concerns, although they pointed out that the number of patients in the studies was small and recommended close follow-up of treated patients.

"It seems like it’s a fairly safe drug," but follow-up is short term and fewer than 200 patients have been treated with teduglutide, said panelist Dr. Kevin Kelly, director of the division of solid tumor oncology at Thomas Jefferson University, Philadelphia. He and others recommended that patients be followed for up to 10 years.

"My gut feeling is that this is probably a very safe drug" that does not increase the risk of carcinogenesis, said another panelist, Dr. Ronald Fogel of the Digestive Health Center of Michigan in Chesterfield. He recommended more aggressive follow-up of treated patients than was proposed by the company, which he said could include serial colonoscopies at 2-year intervals with multiple biopsies at areas of dysplasia.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for people with SBS who are dependent on parenteral nutrition are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

NEW ORLEANS – The increasing rate of injuries, especially catastrophic ones, among cheerleaders has prompted the American Academy of Pediatrics to publish its first policy statement on the competitive, year-round activity.

Although the overall risk of injury in cheerleading is lower than for other sports, it accounted for 65% of all catastrophic injuries to high school female athletes and almost 71% of those in college during a 30-year period ending in 2009.

Naseem S. Miller/IMNG Medical Media

"The academy feels that cheerleading is a valuable activity," said report author Dr. Cynthia LaBella at the annual meeting of the American Academy of Pediatrics. "We just want to make sure that [the cheerleaders] have the same safety precautions in place as those participating in other sports do," noted Dr. LaBella, medical director of the Institute for Sports Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago.

The American Academy of Pediatrics (AAP) has made 12 recommendations to help reduce cheerleading injuries, including a call for cheerleading to be designated as a sport "so that it is subject to rules and regulations set forth by sports governing bodies ... and school athletic departments," according to the report (Pediatrics 2012;130:966-971).

Cheerleading has become increasingly popular, with approximately 400,000 participants in high school cheerleading alone, according to 2009 data from the National Federation of State High School Associations. Yet only 29 state high school athletic associations recognize cheerleading as a sport, according to the AAP report.

Being classified as a sport, the academy points out, brings safety resources and regulations such as qualified coaches as well as access to athletic trainers and team physicians.

The academy also recommends that cheerleaders undergo a preparticipation physical examination and have access to appropriate strength and conditioning programs.

The catastrophic injury rate among female high school cheerleaders was between 0.5 and 1.62, compared with 0.44 for gymnastics. The rate was 0.3 or lower for female athletes participating in sports such as soccer, basketball, and softball. Catastrophic injuries included closed-head injury, skull fractures, cervical spine injuries, paralysis, and death.

Dr. LaBella said the lower rate of catastrophic injury among gymnasts could be due to the level of supervision, better conditioning programs, and more protective equipment, including flooring.

The AAP also recommends that cheerleaders be supervised by qualified coaches who have been properly trained and certified, and avoid performing certain technical skills on hard, wet, or uneven surfaces. "No cheer events should take place on dirt, vinyl floors, concrete, or asphalt," wrote Dr. LaBella and coauthor Dr. Jeffrey Mjaanes, of the departments of orthopedic surgery and pediatrics at Rush University Medical Center, Chicago.

In addition, the AAP recommends that any cheerleader who shows signs of a head injury "should be removed from practice or competition and not be allowed to return until he or she has received written clearance from a physician or a qualified health care provider."

The number of U.S. cheerleaders 6 years and older increased from 3.0 million in 1990 to 3.6 million in 2003, and girls represented 96% of the participants, according to the report.

Middle and high school cheerleaders have lower overall injury rates than collegiate-level cheerleaders, partly because older cheerleaders are better skilled and tend to perform more complex gymnastics and height-based stunts, the authors noted.

Meanwhile, the number of hospital emergency department visits for cheerleading injuries rose from roughly 5,000 in 1980 to 27,000 in 2007, a 400% increase. Of these injuries, 98% were treated and released.

Lower-extremity injuries are the most common injuries (30%-37%), followed by upper-extremities injuries (16%-19%) and trunk injuries (7%-17%).

Concussions and other closed-head injuries account for 4%-6% of all cheerleading injuries, according to the AAP report. Meanwhile, head and neck injuries account for roughly 15% of all cheerleading injuries seen in emergency departments.

Although the concussion rate in cheerleading is low (0.06 per 1,000 exposures) compared with other girls’ sports such as soccer (0.36), the rate increased by 26% annually from 1998 to 2008.

"Our goal is to make people more aware of the potential injury risk," said Dr. LaBella, who is also an associate professor of pediatrics at Northwestern University in Chicago.

She encouraged cheerleaders and those who supervise them to report the injuries. "That knowledge of what's going on with injuries will help with making further recommendations for the future."

Dr. LaBella had no disclosures.

NEW ORLEANS – The increasing rate of injuries, especially catastrophic ones, among cheerleaders has prompted the American Academy of Pediatrics to publish its first policy statement on the competitive, year-round activity.

Although the overall risk of injury in cheerleading is lower than for other sports, it accounted for 65% of all catastrophic injuries to high school female athletes and almost 71% of those in college during a 30-year period ending in 2009.

Naseem S. Miller/IMNG Medical Media

"The academy feels that cheerleading is a valuable activity," said report author Dr. Cynthia LaBella at the annual meeting of the American Academy of Pediatrics. "We just want to make sure that [the cheerleaders] have the same safety precautions in place as those participating in other sports do," noted Dr. LaBella, medical director of the Institute for Sports Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago.

The American Academy of Pediatrics (AAP) has made 12 recommendations to help reduce cheerleading injuries, including a call for cheerleading to be designated as a sport "so that it is subject to rules and regulations set forth by sports governing bodies ... and school athletic departments," according to the report (Pediatrics 2012;130:966-971).

Cheerleading has become increasingly popular, with approximately 400,000 participants in high school cheerleading alone, according to 2009 data from the National Federation of State High School Associations. Yet only 29 state high school athletic associations recognize cheerleading as a sport, according to the AAP report.

Being classified as a sport, the academy points out, brings safety resources and regulations such as qualified coaches as well as access to athletic trainers and team physicians.

The academy also recommends that cheerleaders undergo a preparticipation physical examination and have access to appropriate strength and conditioning programs.

The catastrophic injury rate among female high school cheerleaders was between 0.5 and 1.62, compared with 0.44 for gymnastics. The rate was 0.3 or lower for female athletes participating in sports such as soccer, basketball, and softball. Catastrophic injuries included closed-head injury, skull fractures, cervical spine injuries, paralysis, and death.

Dr. LaBella said the lower rate of catastrophic injury among gymnasts could be due to the level of supervision, better conditioning programs, and more protective equipment, including flooring.

The AAP also recommends that cheerleaders be supervised by qualified coaches who have been properly trained and certified, and avoid performing certain technical skills on hard, wet, or uneven surfaces. "No cheer events should take place on dirt, vinyl floors, concrete, or asphalt," wrote Dr. LaBella and coauthor Dr. Jeffrey Mjaanes, of the departments of orthopedic surgery and pediatrics at Rush University Medical Center, Chicago.

In addition, the AAP recommends that any cheerleader who shows signs of a head injury "should be removed from practice or competition and not be allowed to return until he or she has received written clearance from a physician or a qualified health care provider."

The number of U.S. cheerleaders 6 years and older increased from 3.0 million in 1990 to 3.6 million in 2003, and girls represented 96% of the participants, according to the report.

Middle and high school cheerleaders have lower overall injury rates than collegiate-level cheerleaders, partly because older cheerleaders are better skilled and tend to perform more complex gymnastics and height-based stunts, the authors noted.

Meanwhile, the number of hospital emergency department visits for cheerleading injuries rose from roughly 5,000 in 1980 to 27,000 in 2007, a 400% increase. Of these injuries, 98% were treated and released.

Lower-extremity injuries are the most common injuries (30%-37%), followed by upper-extremities injuries (16%-19%) and trunk injuries (7%-17%).

Concussions and other closed-head injuries account for 4%-6% of all cheerleading injuries, according to the AAP report. Meanwhile, head and neck injuries account for roughly 15% of all cheerleading injuries seen in emergency departments.

Although the concussion rate in cheerleading is low (0.06 per 1,000 exposures) compared with other girls’ sports such as soccer (0.36), the rate increased by 26% annually from 1998 to 2008.

"Our goal is to make people more aware of the potential injury risk," said Dr. LaBella, who is also an associate professor of pediatrics at Northwestern University in Chicago.

She encouraged cheerleaders and those who supervise them to report the injuries. "That knowledge of what's going on with injuries will help with making further recommendations for the future."

Dr. LaBella had no disclosures.

NEW ORLEANS – The increasing rate of injuries, especially catastrophic ones, among cheerleaders has prompted the American Academy of Pediatrics to publish its first policy statement on the competitive, year-round activity.

Although the overall risk of injury in cheerleading is lower than for other sports, it accounted for 65% of all catastrophic injuries to high school female athletes and almost 71% of those in college during a 30-year period ending in 2009.

Naseem S. Miller/IMNG Medical Media

"The academy feels that cheerleading is a valuable activity," said report author Dr. Cynthia LaBella at the annual meeting of the American Academy of Pediatrics. "We just want to make sure that [the cheerleaders] have the same safety precautions in place as those participating in other sports do," noted Dr. LaBella, medical director of the Institute for Sports Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago.

The American Academy of Pediatrics (AAP) has made 12 recommendations to help reduce cheerleading injuries, including a call for cheerleading to be designated as a sport "so that it is subject to rules and regulations set forth by sports governing bodies ... and school athletic departments," according to the report (Pediatrics 2012;130:966-971).

Cheerleading has become increasingly popular, with approximately 400,000 participants in high school cheerleading alone, according to 2009 data from the National Federation of State High School Associations. Yet only 29 state high school athletic associations recognize cheerleading as a sport, according to the AAP report.

Being classified as a sport, the academy points out, brings safety resources and regulations such as qualified coaches as well as access to athletic trainers and team physicians.

The academy also recommends that cheerleaders undergo a preparticipation physical examination and have access to appropriate strength and conditioning programs.

The catastrophic injury rate among female high school cheerleaders was between 0.5 and 1.62, compared with 0.44 for gymnastics. The rate was 0.3 or lower for female athletes participating in sports such as soccer, basketball, and softball. Catastrophic injuries included closed-head injury, skull fractures, cervical spine injuries, paralysis, and death.

Dr. LaBella said the lower rate of catastrophic injury among gymnasts could be due to the level of supervision, better conditioning programs, and more protective equipment, including flooring.

The AAP also recommends that cheerleaders be supervised by qualified coaches who have been properly trained and certified, and avoid performing certain technical skills on hard, wet, or uneven surfaces. "No cheer events should take place on dirt, vinyl floors, concrete, or asphalt," wrote Dr. LaBella and coauthor Dr. Jeffrey Mjaanes, of the departments of orthopedic surgery and pediatrics at Rush University Medical Center, Chicago.

In addition, the AAP recommends that any cheerleader who shows signs of a head injury "should be removed from practice or competition and not be allowed to return until he or she has received written clearance from a physician or a qualified health care provider."

The number of U.S. cheerleaders 6 years and older increased from 3.0 million in 1990 to 3.6 million in 2003, and girls represented 96% of the participants, according to the report.

Middle and high school cheerleaders have lower overall injury rates than collegiate-level cheerleaders, partly because older cheerleaders are better skilled and tend to perform more complex gymnastics and height-based stunts, the authors noted.

Meanwhile, the number of hospital emergency department visits for cheerleading injuries rose from roughly 5,000 in 1980 to 27,000 in 2007, a 400% increase. Of these injuries, 98% were treated and released.

Lower-extremity injuries are the most common injuries (30%-37%), followed by upper-extremities injuries (16%-19%) and trunk injuries (7%-17%).

Concussions and other closed-head injuries account for 4%-6% of all cheerleading injuries, according to the AAP report. Meanwhile, head and neck injuries account for roughly 15% of all cheerleading injuries seen in emergency departments.

Although the concussion rate in cheerleading is low (0.06 per 1,000 exposures) compared with other girls’ sports such as soccer (0.36), the rate increased by 26% annually from 1998 to 2008.

"Our goal is to make people more aware of the potential injury risk," said Dr. LaBella, who is also an associate professor of pediatrics at Northwestern University in Chicago.

She encouraged cheerleaders and those who supervise them to report the injuries. "That knowledge of what's going on with injuries will help with making further recommendations for the future."

Dr. LaBella had no disclosures.

From the time that propranolol significantly lowered mortality after an acute myocardial infarction in the Beta-Blocker Heart Attack Trial in 1981, it took nearly 20 years for beta-blocker therapy to take hold as standard practice in AMI patients. Now, results of a recent trial may cause many to question the established therapy.

The Nov. 6, 1981, issue of JAMA announced that the National Heart, Lung, and Blood Institute had "taken the unusual step of curtailing" the Beta-Blocker Heart Attack Trial (BHAT) on the basis of findings that treatment of patients with the beta-adrenergic blocking agent, propranolol, resulted in a 26% decrease in all-cause mortality and a 23% decrease in sudden death (JAMA 1982;247:1707-14).

The study included 3,837 patients treated within 5-21 days of an acute myocardial infarction (AMI) and randomized to either propranolol 160-240 mg/day or placebo. Two-thirds of the patients had a ST-elevation MI; the remaining patients had symptoms compatible with an AMI with electrocardiographic changes accompanied by an increase in serum enzymatic elevations (serum glutamic oxaloacetic transaminase or creatine phosphokinase). This followed the report of similar results in Europe with the beta-blocker timolol in a similar group of patients. Since those early reports of randomized clinical trials, based on a subgroup analysis of BHAT, confirmed the benefit of beta-blocker therapy for both ischemic and nonischemic systolic heart failure. As steering committee chair of BHAT, I was excited about the result of our study and anticipated that beta-blocker therapy would rapidly become part of the treatment of AMI.

This was not to be. It took almost 20 years before beta-blocker therapy was incorporated into the standard treatment of AMI patients. In the interval, thousands of patients who could have benefited with this therapy died. As late as 1998, fewer than 50% of AMI patients without contraindication to therapy received that class of drug.

Why did it take so long? At the time of the BHAT results, many of the leading academic cardiologists were enamored with the use of calcium entry blocking agents for AMI, for which there were little data but a lot of encouragement by pharmaceutical companies. When propranolol went off patent and became available as a generic, there was little industrial support to publicize its benefit. Furthermore, there was little interest at the National Heart, Lung, and Blood Institute to educate physicians about the importance of BHAT. In 1996, beta-blocker therapy post-AMI was established as a quality standard by the National Committee for Quality Assurance (NCQA). At about the same time, it was incorporated in the American College of Cardiology guidelines. Not until 2000, 19 years after the initial report of beta-blocker therapy, did its usage reach 90% at discharge. A recent study from the NCQA indicated that 6 months after discharge only 71% of patients were taking the medication.

In the intervening 2 decades, the definition of an AMI has dramatically changed as a result of more sensitive, if less specific, enzyme measurements. In 1981, most of the patients in BHAT had a STEMI, whereas contemporary clinical trials include less than one-third STEMI patients. Therapy certainly has changed: first with the use of thrombolytic therapy and subsequently with the wide use of interventional angioplasty technology, particularly in the STEMI population. Aspirin, statins, and ACE inhibitors have also been added to the therapeutic mix.

Now, an observational study of almost 7,000 patients with a history of an AMI collected in 2004 and followed for 43 months, suggests that beta-blocker therapy is no longer necessary. Using a composite end point including cardiovascular death, nonfatal MI, or stroke, patients receiving propranolol had an event rate of 16.9%, compared with 18.6% not taking beta-blocker (hazard ratio, .90; P less than .14) (JAMA 2012;308:1340-9). It should be noted, however, that 74% of the patients in the study had a history of hypertension, 44% angina, and 22% heart failure, all clinical problems for which beta-blockers have been proven to be effective.

The most recent American College of Cardiology/American Heart Association guidelines suggest that beta-blocker therapy "is greatest (benefit) among patients with recent myocardial infarction [of up to 3 years prior] and/or left ventricular systolic dysfunction [left ventricular ejection fraction of 40% or less]. For those patient without these class I indication, [beta]-blocker therapy is optional (class IIa or IIb) (Circulation 2011;124:2458-73). I suppose that if you can find an AMI patient without hypertension, angina, or heart failure, discontinuing beta-blocker therapy could be justified. Until that rare patient appears in my office, I plan to maintain beta-blockers in my post-AMI patients.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

This column, "Heart of the Matter," appears regularly in Cardiology News.

From the time that propranolol significantly lowered mortality after an acute myocardial infarction in the Beta-Blocker Heart Attack Trial in 1981, it took nearly 20 years for beta-blocker therapy to take hold as standard practice in AMI patients. Now, results of a recent trial may cause many to question the established therapy.

The Nov. 6, 1981, issue of JAMA announced that the National Heart, Lung, and Blood Institute had "taken the unusual step of curtailing" the Beta-Blocker Heart Attack Trial (BHAT) on the basis of findings that treatment of patients with the beta-adrenergic blocking agent, propranolol, resulted in a 26% decrease in all-cause mortality and a 23% decrease in sudden death (JAMA 1982;247:1707-14).

The study included 3,837 patients treated within 5-21 days of an acute myocardial infarction (AMI) and randomized to either propranolol 160-240 mg/day or placebo. Two-thirds of the patients had a ST-elevation MI; the remaining patients had symptoms compatible with an AMI with electrocardiographic changes accompanied by an increase in serum enzymatic elevations (serum glutamic oxaloacetic transaminase or creatine phosphokinase). This followed the report of similar results in Europe with the beta-blocker timolol in a similar group of patients. Since those early reports of randomized clinical trials, based on a subgroup analysis of BHAT, confirmed the benefit of beta-blocker therapy for both ischemic and nonischemic systolic heart failure. As steering committee chair of BHAT, I was excited about the result of our study and anticipated that beta-blocker therapy would rapidly become part of the treatment of AMI.

This was not to be. It took almost 20 years before beta-blocker therapy was incorporated into the standard treatment of AMI patients. In the interval, thousands of patients who could have benefited with this therapy died. As late as 1998, fewer than 50% of AMI patients without contraindication to therapy received that class of drug.

Why did it take so long? At the time of the BHAT results, many of the leading academic cardiologists were enamored with the use of calcium entry blocking agents for AMI, for which there were little data but a lot of encouragement by pharmaceutical companies. When propranolol went off patent and became available as a generic, there was little industrial support to publicize its benefit. Furthermore, there was little interest at the National Heart, Lung, and Blood Institute to educate physicians about the importance of BHAT. In 1996, beta-blocker therapy post-AMI was established as a quality standard by the National Committee for Quality Assurance (NCQA). At about the same time, it was incorporated in the American College of Cardiology guidelines. Not until 2000, 19 years after the initial report of beta-blocker therapy, did its usage reach 90% at discharge. A recent study from the NCQA indicated that 6 months after discharge only 71% of patients were taking the medication.

In the intervening 2 decades, the definition of an AMI has dramatically changed as a result of more sensitive, if less specific, enzyme measurements. In 1981, most of the patients in BHAT had a STEMI, whereas contemporary clinical trials include less than one-third STEMI patients. Therapy certainly has changed: first with the use of thrombolytic therapy and subsequently with the wide use of interventional angioplasty technology, particularly in the STEMI population. Aspirin, statins, and ACE inhibitors have also been added to the therapeutic mix.

Now, an observational study of almost 7,000 patients with a history of an AMI collected in 2004 and followed for 43 months, suggests that beta-blocker therapy is no longer necessary. Using a composite end point including cardiovascular death, nonfatal MI, or stroke, patients receiving propranolol had an event rate of 16.9%, compared with 18.6% not taking beta-blocker (hazard ratio, .90; P less than .14) (JAMA 2012;308:1340-9). It should be noted, however, that 74% of the patients in the study had a history of hypertension, 44% angina, and 22% heart failure, all clinical problems for which beta-blockers have been proven to be effective.

The most recent American College of Cardiology/American Heart Association guidelines suggest that beta-blocker therapy "is greatest (benefit) among patients with recent myocardial infarction [of up to 3 years prior] and/or left ventricular systolic dysfunction [left ventricular ejection fraction of 40% or less]. For those patient without these class I indication, [beta]-blocker therapy is optional (class IIa or IIb) (Circulation 2011;124:2458-73). I suppose that if you can find an AMI patient without hypertension, angina, or heart failure, discontinuing beta-blocker therapy could be justified. Until that rare patient appears in my office, I plan to maintain beta-blockers in my post-AMI patients.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

This column, "Heart of the Matter," appears regularly in Cardiology News.

From the time that propranolol significantly lowered mortality after an acute myocardial infarction in the Beta-Blocker Heart Attack Trial in 1981, it took nearly 20 years for beta-blocker therapy to take hold as standard practice in AMI patients. Now, results of a recent trial may cause many to question the established therapy.

The Nov. 6, 1981, issue of JAMA announced that the National Heart, Lung, and Blood Institute had "taken the unusual step of curtailing" the Beta-Blocker Heart Attack Trial (BHAT) on the basis of findings that treatment of patients with the beta-adrenergic blocking agent, propranolol, resulted in a 26% decrease in all-cause mortality and a 23% decrease in sudden death (JAMA 1982;247:1707-14).

The study included 3,837 patients treated within 5-21 days of an acute myocardial infarction (AMI) and randomized to either propranolol 160-240 mg/day or placebo. Two-thirds of the patients had a ST-elevation MI; the remaining patients had symptoms compatible with an AMI with electrocardiographic changes accompanied by an increase in serum enzymatic elevations (serum glutamic oxaloacetic transaminase or creatine phosphokinase). This followed the report of similar results in Europe with the beta-blocker timolol in a similar group of patients. Since those early reports of randomized clinical trials, based on a subgroup analysis of BHAT, confirmed the benefit of beta-blocker therapy for both ischemic and nonischemic systolic heart failure. As steering committee chair of BHAT, I was excited about the result of our study and anticipated that beta-blocker therapy would rapidly become part of the treatment of AMI.

This was not to be. It took almost 20 years before beta-blocker therapy was incorporated into the standard treatment of AMI patients. In the interval, thousands of patients who could have benefited with this therapy died. As late as 1998, fewer than 50% of AMI patients without contraindication to therapy received that class of drug.

Why did it take so long? At the time of the BHAT results, many of the leading academic cardiologists were enamored with the use of calcium entry blocking agents for AMI, for which there were little data but a lot of encouragement by pharmaceutical companies. When propranolol went off patent and became available as a generic, there was little industrial support to publicize its benefit. Furthermore, there was little interest at the National Heart, Lung, and Blood Institute to educate physicians about the importance of BHAT. In 1996, beta-blocker therapy post-AMI was established as a quality standard by the National Committee for Quality Assurance (NCQA). At about the same time, it was incorporated in the American College of Cardiology guidelines. Not until 2000, 19 years after the initial report of beta-blocker therapy, did its usage reach 90% at discharge. A recent study from the NCQA indicated that 6 months after discharge only 71% of patients were taking the medication.

In the intervening 2 decades, the definition of an AMI has dramatically changed as a result of more sensitive, if less specific, enzyme measurements. In 1981, most of the patients in BHAT had a STEMI, whereas contemporary clinical trials include less than one-third STEMI patients. Therapy certainly has changed: first with the use of thrombolytic therapy and subsequently with the wide use of interventional angioplasty technology, particularly in the STEMI population. Aspirin, statins, and ACE inhibitors have also been added to the therapeutic mix.

Now, an observational study of almost 7,000 patients with a history of an AMI collected in 2004 and followed for 43 months, suggests that beta-blocker therapy is no longer necessary. Using a composite end point including cardiovascular death, nonfatal MI, or stroke, patients receiving propranolol had an event rate of 16.9%, compared with 18.6% not taking beta-blocker (hazard ratio, .90; P less than .14) (JAMA 2012;308:1340-9). It should be noted, however, that 74% of the patients in the study had a history of hypertension, 44% angina, and 22% heart failure, all clinical problems for which beta-blockers have been proven to be effective.

The most recent American College of Cardiology/American Heart Association guidelines suggest that beta-blocker therapy "is greatest (benefit) among patients with recent myocardial infarction [of up to 3 years prior] and/or left ventricular systolic dysfunction [left ventricular ejection fraction of 40% or less]. For those patient without these class I indication, [beta]-blocker therapy is optional (class IIa or IIb) (Circulation 2011;124:2458-73). I suppose that if you can find an AMI patient without hypertension, angina, or heart failure, discontinuing beta-blocker therapy could be justified. Until that rare patient appears in my office, I plan to maintain beta-blockers in my post-AMI patients.

Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

This column, "Heart of the Matter," appears regularly in Cardiology News.