Deepak Chitnis

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

Long-acting reversible contraception can lead to significantly decreased rates of pregnancy, abortion, and births among teenagers in the United States, according to a web presentation given by the American Congress of Obstetricians and Gynecologists.

“Teen birth is a public health issue,” said Dr. Melissa Kottke, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University, Atlanta, adding that teen birth is not only an outcome and predictor of poverty, but has a proven correlation with poor education attainment for teen mothers and is a $9 billion burden for taxpayers in the United States.

Long-acting reversible contraception (LARC) involves two methods of contraception, the intrauterine device (IUD) or the birth control implant, which are effective and reversible ways of preventing pregnancies for as long as several years. The IUD can be either hormonal, which releases progestin into the uterus and is effective for up to 5 years, or a copper IUD, which can be effective for up to 10 years. The implant method involves placing a small device in the patient’s arm, which secretes progestin to stop ovulation. According to ACOG, LARC methods result in fewer than 1 in 100 women getting pregnant during the first year of use, which is statistically similar to rates of outright sterilization.

Dr. Kottke cited a 2012 CHOICE study, published by the New England Journal of Medicine and conducted by researchers at Washington University in St. Louis, which enrolled 1,404 teenagers and gave them the option of choosing either shorter-acting contraceptive methods (28% chosen) or LARC (72% chosen); results showed that unintended pregnancies were 20 times more likely in teens who chose contraceptive methods like pills, patches, and rings than they were in teens who chose LARC (N. Engl. J. Med. 2012;366:1998-2007).

Another study, known as the 2014 Colorado Family Planning Initiative (CFPI) published by Perspectives on Sexual and Reproductive Health, used private funds to provide LARC methods free of charge in 37 of Colorado’s 64 counties between 2008 and 2011. Over that span, LARC use among 15- to 24-year-olds increased from 4.5% to 19.4%, with insertion ratios for low-income young women increasing from 1:170 to 1:15. Annually, LARC insertions increased from 620 to 3,159 in 2008 and 2011, respectively (Perspect. Sex. Reprod. Health 2014;46:125-32).

Counties which opted to receive LARC funding saw a 24% decrease in high-risk pregnancies, as opposed to just a 6% decrease in non-LARC counties. Abortion rates also fell by 34% and 18%, respectively, and LARC counties saw a 23% decrease in infants served by the federal Women, Infants, and Children’s (WIC) program.

Noting that rates of teen pregnancies, abortions, and births are at an all-time low across ages, ethnicities, and states, Dr. Kottke advised that while there is a lot of good news, there is also “an element of caution” that must be heeded: repeat teen births in the United States are still high, and must be reduced dramatically. Using LARC, she said, could help effectively combat this problem.

Around 66,800 repeat teen births occurred in the United States in 2010, all of which were in girls between the ages of 15 and 19 years. Of those, 57,200 were second births, 8,400 were third births, and 1,200 were in mothers giving birth to at least their fourth child. About 1,700 teenagers aged 15-17 years give birth each week, according to figures from the Centers for Disease Control and Prevention, and one in four teen births in the United States affect girls aged 15-17 years. However, Dr. Kottke noted that birth rates for girls aged 10-14 years have dropped to their lowest rate since the United States government began recording these statistics.

Dr. Kottke concluded by stating the importance of making pregnancy clinics and contraceptive information easily accessible for teenagers, adding the importance of respecting confidentiality, and making sure clinics and counselors are available outside of school hours so that teenagers can get the help and advice they need without having to miss out on school.

Dr. Kottke disclosed that she is an Implanon trainer with Merck. Several of her coinvestigators made similar disclosures.

[email protected]

Long-acting reversible contraception can lead to significantly decreased rates of pregnancy, abortion, and births among teenagers in the United States, according to a web presentation given by the American Congress of Obstetricians and Gynecologists.

“Teen birth is a public health issue,” said Dr. Melissa Kottke, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University, Atlanta, adding that teen birth is not only an outcome and predictor of poverty, but has a proven correlation with poor education attainment for teen mothers and is a $9 billion burden for taxpayers in the United States.

Long-acting reversible contraception (LARC) involves two methods of contraception, the intrauterine device (IUD) or the birth control implant, which are effective and reversible ways of preventing pregnancies for as long as several years. The IUD can be either hormonal, which releases progestin into the uterus and is effective for up to 5 years, or a copper IUD, which can be effective for up to 10 years. The implant method involves placing a small device in the patient’s arm, which secretes progestin to stop ovulation. According to ACOG, LARC methods result in fewer than 1 in 100 women getting pregnant during the first year of use, which is statistically similar to rates of outright sterilization.

Dr. Kottke cited a 2012 CHOICE study, published by the New England Journal of Medicine and conducted by researchers at Washington University in St. Louis, which enrolled 1,404 teenagers and gave them the option of choosing either shorter-acting contraceptive methods (28% chosen) or LARC (72% chosen); results showed that unintended pregnancies were 20 times more likely in teens who chose contraceptive methods like pills, patches, and rings than they were in teens who chose LARC (N. Engl. J. Med. 2012;366:1998-2007).

Another study, known as the 2014 Colorado Family Planning Initiative (CFPI) published by Perspectives on Sexual and Reproductive Health, used private funds to provide LARC methods free of charge in 37 of Colorado’s 64 counties between 2008 and 2011. Over that span, LARC use among 15- to 24-year-olds increased from 4.5% to 19.4%, with insertion ratios for low-income young women increasing from 1:170 to 1:15. Annually, LARC insertions increased from 620 to 3,159 in 2008 and 2011, respectively (Perspect. Sex. Reprod. Health 2014;46:125-32).

Counties which opted to receive LARC funding saw a 24% decrease in high-risk pregnancies, as opposed to just a 6% decrease in non-LARC counties. Abortion rates also fell by 34% and 18%, respectively, and LARC counties saw a 23% decrease in infants served by the federal Women, Infants, and Children’s (WIC) program.

Noting that rates of teen pregnancies, abortions, and births are at an all-time low across ages, ethnicities, and states, Dr. Kottke advised that while there is a lot of good news, there is also “an element of caution” that must be heeded: repeat teen births in the United States are still high, and must be reduced dramatically. Using LARC, she said, could help effectively combat this problem.

Around 66,800 repeat teen births occurred in the United States in 2010, all of which were in girls between the ages of 15 and 19 years. Of those, 57,200 were second births, 8,400 were third births, and 1,200 were in mothers giving birth to at least their fourth child. About 1,700 teenagers aged 15-17 years give birth each week, according to figures from the Centers for Disease Control and Prevention, and one in four teen births in the United States affect girls aged 15-17 years. However, Dr. Kottke noted that birth rates for girls aged 10-14 years have dropped to their lowest rate since the United States government began recording these statistics.

Dr. Kottke concluded by stating the importance of making pregnancy clinics and contraceptive information easily accessible for teenagers, adding the importance of respecting confidentiality, and making sure clinics and counselors are available outside of school hours so that teenagers can get the help and advice they need without having to miss out on school.

Dr. Kottke disclosed that she is an Implanon trainer with Merck. Several of her coinvestigators made similar disclosures.

[email protected]

Long-acting reversible contraception can lead to significantly decreased rates of pregnancy, abortion, and births among teenagers in the United States, according to a web presentation given by the American Congress of Obstetricians and Gynecologists.

“Teen birth is a public health issue,” said Dr. Melissa Kottke, director of the Jane Fonda Center for Adolescent Reproductive Health at Emory University, Atlanta, adding that teen birth is not only an outcome and predictor of poverty, but has a proven correlation with poor education attainment for teen mothers and is a $9 billion burden for taxpayers in the United States.

Long-acting reversible contraception (LARC) involves two methods of contraception, the intrauterine device (IUD) or the birth control implant, which are effective and reversible ways of preventing pregnancies for as long as several years. The IUD can be either hormonal, which releases progestin into the uterus and is effective for up to 5 years, or a copper IUD, which can be effective for up to 10 years. The implant method involves placing a small device in the patient’s arm, which secretes progestin to stop ovulation. According to ACOG, LARC methods result in fewer than 1 in 100 women getting pregnant during the first year of use, which is statistically similar to rates of outright sterilization.

Dr. Kottke cited a 2012 CHOICE study, published by the New England Journal of Medicine and conducted by researchers at Washington University in St. Louis, which enrolled 1,404 teenagers and gave them the option of choosing either shorter-acting contraceptive methods (28% chosen) or LARC (72% chosen); results showed that unintended pregnancies were 20 times more likely in teens who chose contraceptive methods like pills, patches, and rings than they were in teens who chose LARC (N. Engl. J. Med. 2012;366:1998-2007).

Another study, known as the 2014 Colorado Family Planning Initiative (CFPI) published by Perspectives on Sexual and Reproductive Health, used private funds to provide LARC methods free of charge in 37 of Colorado’s 64 counties between 2008 and 2011. Over that span, LARC use among 15- to 24-year-olds increased from 4.5% to 19.4%, with insertion ratios for low-income young women increasing from 1:170 to 1:15. Annually, LARC insertions increased from 620 to 3,159 in 2008 and 2011, respectively (Perspect. Sex. Reprod. Health 2014;46:125-32).

Counties which opted to receive LARC funding saw a 24% decrease in high-risk pregnancies, as opposed to just a 6% decrease in non-LARC counties. Abortion rates also fell by 34% and 18%, respectively, and LARC counties saw a 23% decrease in infants served by the federal Women, Infants, and Children’s (WIC) program.

Noting that rates of teen pregnancies, abortions, and births are at an all-time low across ages, ethnicities, and states, Dr. Kottke advised that while there is a lot of good news, there is also “an element of caution” that must be heeded: repeat teen births in the United States are still high, and must be reduced dramatically. Using LARC, she said, could help effectively combat this problem.

Around 66,800 repeat teen births occurred in the United States in 2010, all of which were in girls between the ages of 15 and 19 years. Of those, 57,200 were second births, 8,400 were third births, and 1,200 were in mothers giving birth to at least their fourth child. About 1,700 teenagers aged 15-17 years give birth each week, according to figures from the Centers for Disease Control and Prevention, and one in four teen births in the United States affect girls aged 15-17 years. However, Dr. Kottke noted that birth rates for girls aged 10-14 years have dropped to their lowest rate since the United States government began recording these statistics.

Dr. Kottke concluded by stating the importance of making pregnancy clinics and contraceptive information easily accessible for teenagers, adding the importance of respecting confidentiality, and making sure clinics and counselors are available outside of school hours so that teenagers can get the help and advice they need without having to miss out on school.

Dr. Kottke disclosed that she is an Implanon trainer with Merck. Several of her coinvestigators made similar disclosures.

[email protected]

A state of minimal disease activity in patients with psoriatic arthritis is sustainable over several years by using treatments with tumor necrosis factor–alpha blockers, according to findings from a single-center, retrospective cohort study.

The study is the first to report on the predictors of minimal disease activity (MDA) in patients with psoriatic arthritis (PsA) taking TNF-alpha inhibitors in a clinical setting and “is also the first “to report about PsA patients who achieved and continued to be in MDA state after treatment change,” wrote the study investigators, who were led by Dr. Amir Haddad of the University of Toronto.

The investigators reported on 226 patients with PsA who were not in an MDA state when they presented to the University of Toronto and were treated with TNF-alpha inhibitors during 2000-2012. They had excluded 23 patients who had MDA when treatment began and 57 who were on TNF-alpha blockers prior to enrollment (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22529]).

The patients were 65% male with an average diagnosis age of 36.0 years and were followed at 6-12 month intervals. The authors defined MDA according to the criteria provided by Coates et al. (Ann. Rheum. Dis. 2010;69:48-53), which required patients to meet at least five of seven criteria: 0-1 tender joints ; 0-1 swollen joints; Psoriasis Activity and Severity Index of 1 or less or body surface area of 3 or less; patient pain visual analogue score (VAS) of 15 or less; patient global disease activity VAS of 20 or less; health assessment questionnaire of 0.5 or less; tender entheseal points of 1 or less.

A total of 145 patients (64%) achieved MDA status after an average of 1.30 months (standard deviation, 1.51), and 88 (61%) achieved sustained MDA (defined as at least 1 year) for a mean of 3.46 years (standard deviation, 2.25). Another 17 patients remained in an MDA state after reducing their anti–TNF-alpha drug dose, including 9 who withdrew anti–TNF-alpha treatment completely, and these patients remained in an MDA state for a mean of 2.11 years. The investigators noted that “no protocol was used for tapering the dose and it was left to patient’s preference,” and that MDA was sustained for longer periods of time in patients who reduced the TNF-alpha inhibitor dose and for shorter periods in patients who withdrew the treatment.

Male sex and a normal erythrocyte sedimentation rate (ESR) were found to be reliable predictors of achieving MDA. The authors cited previous studies on ankylosing spondylitis or axial spondyloarthritis, and noted that low ESR/C-reactive protein is considered a predictor for nonresponse to TNF-alpha blockers, but caution that the results of their own study may “simply [be] from using different outcome measures for response.”

The authors disclosed that all but one of them are members of the University of Toronto’s Psoriatic Arthritis Program, which is partly funded by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. Additionally, Dr. Haddad disclosed that he was supported by unrestricted educational grants from Janssen and UCB.

[email protected]

A state of minimal disease activity in patients with psoriatic arthritis is sustainable over several years by using treatments with tumor necrosis factor–alpha blockers, according to findings from a single-center, retrospective cohort study.

The study is the first to report on the predictors of minimal disease activity (MDA) in patients with psoriatic arthritis (PsA) taking TNF-alpha inhibitors in a clinical setting and “is also the first “to report about PsA patients who achieved and continued to be in MDA state after treatment change,” wrote the study investigators, who were led by Dr. Amir Haddad of the University of Toronto.

The investigators reported on 226 patients with PsA who were not in an MDA state when they presented to the University of Toronto and were treated with TNF-alpha inhibitors during 2000-2012. They had excluded 23 patients who had MDA when treatment began and 57 who were on TNF-alpha blockers prior to enrollment (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22529]).

The patients were 65% male with an average diagnosis age of 36.0 years and were followed at 6-12 month intervals. The authors defined MDA according to the criteria provided by Coates et al. (Ann. Rheum. Dis. 2010;69:48-53), which required patients to meet at least five of seven criteria: 0-1 tender joints ; 0-1 swollen joints; Psoriasis Activity and Severity Index of 1 or less or body surface area of 3 or less; patient pain visual analogue score (VAS) of 15 or less; patient global disease activity VAS of 20 or less; health assessment questionnaire of 0.5 or less; tender entheseal points of 1 or less.

A total of 145 patients (64%) achieved MDA status after an average of 1.30 months (standard deviation, 1.51), and 88 (61%) achieved sustained MDA (defined as at least 1 year) for a mean of 3.46 years (standard deviation, 2.25). Another 17 patients remained in an MDA state after reducing their anti–TNF-alpha drug dose, including 9 who withdrew anti–TNF-alpha treatment completely, and these patients remained in an MDA state for a mean of 2.11 years. The investigators noted that “no protocol was used for tapering the dose and it was left to patient’s preference,” and that MDA was sustained for longer periods of time in patients who reduced the TNF-alpha inhibitor dose and for shorter periods in patients who withdrew the treatment.

Male sex and a normal erythrocyte sedimentation rate (ESR) were found to be reliable predictors of achieving MDA. The authors cited previous studies on ankylosing spondylitis or axial spondyloarthritis, and noted that low ESR/C-reactive protein is considered a predictor for nonresponse to TNF-alpha blockers, but caution that the results of their own study may “simply [be] from using different outcome measures for response.”

The authors disclosed that all but one of them are members of the University of Toronto’s Psoriatic Arthritis Program, which is partly funded by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. Additionally, Dr. Haddad disclosed that he was supported by unrestricted educational grants from Janssen and UCB.

[email protected]

A state of minimal disease activity in patients with psoriatic arthritis is sustainable over several years by using treatments with tumor necrosis factor–alpha blockers, according to findings from a single-center, retrospective cohort study.

The study is the first to report on the predictors of minimal disease activity (MDA) in patients with psoriatic arthritis (PsA) taking TNF-alpha inhibitors in a clinical setting and “is also the first “to report about PsA patients who achieved and continued to be in MDA state after treatment change,” wrote the study investigators, who were led by Dr. Amir Haddad of the University of Toronto.

The investigators reported on 226 patients with PsA who were not in an MDA state when they presented to the University of Toronto and were treated with TNF-alpha inhibitors during 2000-2012. They had excluded 23 patients who had MDA when treatment began and 57 who were on TNF-alpha blockers prior to enrollment (Arthritis Care Res. 2014 Dec. 2 [doi:10.1002/acr.22529]).

The patients were 65% male with an average diagnosis age of 36.0 years and were followed at 6-12 month intervals. The authors defined MDA according to the criteria provided by Coates et al. (Ann. Rheum. Dis. 2010;69:48-53), which required patients to meet at least five of seven criteria: 0-1 tender joints ; 0-1 swollen joints; Psoriasis Activity and Severity Index of 1 or less or body surface area of 3 or less; patient pain visual analogue score (VAS) of 15 or less; patient global disease activity VAS of 20 or less; health assessment questionnaire of 0.5 or less; tender entheseal points of 1 or less.

A total of 145 patients (64%) achieved MDA status after an average of 1.30 months (standard deviation, 1.51), and 88 (61%) achieved sustained MDA (defined as at least 1 year) for a mean of 3.46 years (standard deviation, 2.25). Another 17 patients remained in an MDA state after reducing their anti–TNF-alpha drug dose, including 9 who withdrew anti–TNF-alpha treatment completely, and these patients remained in an MDA state for a mean of 2.11 years. The investigators noted that “no protocol was used for tapering the dose and it was left to patient’s preference,” and that MDA was sustained for longer periods of time in patients who reduced the TNF-alpha inhibitor dose and for shorter periods in patients who withdrew the treatment.

Male sex and a normal erythrocyte sedimentation rate (ESR) were found to be reliable predictors of achieving MDA. The authors cited previous studies on ankylosing spondylitis or axial spondyloarthritis, and noted that low ESR/C-reactive protein is considered a predictor for nonresponse to TNF-alpha blockers, but caution that the results of their own study may “simply [be] from using different outcome measures for response.”

The authors disclosed that all but one of them are members of the University of Toronto’s Psoriatic Arthritis Program, which is partly funded by the Arthritis Society, the Canadian Institutes of Health Research, and the Krembil Foundation. Additionally, Dr. Haddad disclosed that he was supported by unrestricted educational grants from Janssen and UCB.

[email protected]

Docetaxel/oxaliplatin/5-fluorouracil should be considered as either a primary or subsidiary component of treatments for advanced gastric cancer, according to the results of a study published online Nov. 21 in the Annals of Oncology.

“Recent attention has focused on newer platinum compounds such as oxaliplatin and the oral fluoropyrimidine capecitabine and on taxane-containing triplet combinations [and] the combination of docetaxel, cisplatin and infusional 5-FU (DCF) significantly improved progression-free survival (PFS) and overall survival (OS), compared with cisplatin/5-FU (CF),” wrote the authors, led by Dr. Eric Van Cutsem of University Hospitals Leuven (Belgium). “However, the DCF regimen has been associated with increased toxicity, compared with CF and has not been used extensively in clinical practice or as the preferred chemotherapy backbone in clinical trials evaluating new targeted agents,” they wrote (Ann. Oncol. 2014 [doi:10.1093/annonc/mdu496]).

In a prospective, multinational, randomized, phase II trial, investigators compared the efficacy of gastric cancer treatments with docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX). Researchers determined the “optimal dose” for each regimen, after which a total of 254 patients – all of whom were aged at least 18 years, with Karnofsky Performance Status scores greater than 70, histologically proven metastatic or locally recurrent gastric adenocarcinoma – were randomized using “an interactive voice response system, with stratification by country, weight loss (≤5% or >5%), and disease measurability.”

Ultimately, 248 patients received full treatments of one of the three optimized dose regimens. Investigators took note of both PFS and OS rates, both of which had higher medians in the TEF group than in either the TE or the TEX: 7.66 months TEF versus 4.50 months TE and 5.55 months TEX for PFS and 14.59 months TEF versus 8.97 months TE and 11.30 months TEX for OS. Tumor response rates, complete or partial, were also higher in the TEF group: 46.6% versus 23.1% for TE and 25.6% for TEX. In terms of adverse effects and the frequency of such occurrences, the numbers were similar across all three groups. The most commonly reported side effects were fatigue (21%), sensory neuropathy (14%), and diarrhea (13%).

In order to account for potential toxicity, which would offset patient survival data, the investigators used a therapeutic index relating their PFS data to a measure of tolerability of febrile neutropenia, which was reported in all three groups: 2% TEF, 14% TE, and 9% TEX.

“Using this index, TEF was very favorable, compared with TE and TEX and also with historical data for DCF and CF, thus providing evidence of an improved benefit:risk profile with TEF, compared with the standard treatment in advanced GC,” Dr. Van Cutsem and his coauthors noted.

Dr. Van Cutsem and coauthor Dr. J. Tabernero have received research funding from Sanofi, which also supported the study. Dr. Tabernero has also acted as a consultant for and has received honoraria from Sanofi. All other coauthors reported no financial conflicts of interest.

[email protected]

Docetaxel/oxaliplatin/5-fluorouracil should be considered as either a primary or subsidiary component of treatments for advanced gastric cancer, according to the results of a study published online Nov. 21 in the Annals of Oncology.

“Recent attention has focused on newer platinum compounds such as oxaliplatin and the oral fluoropyrimidine capecitabine and on taxane-containing triplet combinations [and] the combination of docetaxel, cisplatin and infusional 5-FU (DCF) significantly improved progression-free survival (PFS) and overall survival (OS), compared with cisplatin/5-FU (CF),” wrote the authors, led by Dr. Eric Van Cutsem of University Hospitals Leuven (Belgium). “However, the DCF regimen has been associated with increased toxicity, compared with CF and has not been used extensively in clinical practice or as the preferred chemotherapy backbone in clinical trials evaluating new targeted agents,” they wrote (Ann. Oncol. 2014 [doi:10.1093/annonc/mdu496]).

In a prospective, multinational, randomized, phase II trial, investigators compared the efficacy of gastric cancer treatments with docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX). Researchers determined the “optimal dose” for each regimen, after which a total of 254 patients – all of whom were aged at least 18 years, with Karnofsky Performance Status scores greater than 70, histologically proven metastatic or locally recurrent gastric adenocarcinoma – were randomized using “an interactive voice response system, with stratification by country, weight loss (≤5% or >5%), and disease measurability.”

Ultimately, 248 patients received full treatments of one of the three optimized dose regimens. Investigators took note of both PFS and OS rates, both of which had higher medians in the TEF group than in either the TE or the TEX: 7.66 months TEF versus 4.50 months TE and 5.55 months TEX for PFS and 14.59 months TEF versus 8.97 months TE and 11.30 months TEX for OS. Tumor response rates, complete or partial, were also higher in the TEF group: 46.6% versus 23.1% for TE and 25.6% for TEX. In terms of adverse effects and the frequency of such occurrences, the numbers were similar across all three groups. The most commonly reported side effects were fatigue (21%), sensory neuropathy (14%), and diarrhea (13%).

In order to account for potential toxicity, which would offset patient survival data, the investigators used a therapeutic index relating their PFS data to a measure of tolerability of febrile neutropenia, which was reported in all three groups: 2% TEF, 14% TE, and 9% TEX.

“Using this index, TEF was very favorable, compared with TE and TEX and also with historical data for DCF and CF, thus providing evidence of an improved benefit:risk profile with TEF, compared with the standard treatment in advanced GC,” Dr. Van Cutsem and his coauthors noted.

Dr. Van Cutsem and coauthor Dr. J. Tabernero have received research funding from Sanofi, which also supported the study. Dr. Tabernero has also acted as a consultant for and has received honoraria from Sanofi. All other coauthors reported no financial conflicts of interest.

[email protected]

Docetaxel/oxaliplatin/5-fluorouracil should be considered as either a primary or subsidiary component of treatments for advanced gastric cancer, according to the results of a study published online Nov. 21 in the Annals of Oncology.

“Recent attention has focused on newer platinum compounds such as oxaliplatin and the oral fluoropyrimidine capecitabine and on taxane-containing triplet combinations [and] the combination of docetaxel, cisplatin and infusional 5-FU (DCF) significantly improved progression-free survival (PFS) and overall survival (OS), compared with cisplatin/5-FU (CF),” wrote the authors, led by Dr. Eric Van Cutsem of University Hospitals Leuven (Belgium). “However, the DCF regimen has been associated with increased toxicity, compared with CF and has not been used extensively in clinical practice or as the preferred chemotherapy backbone in clinical trials evaluating new targeted agents,” they wrote (Ann. Oncol. 2014 [doi:10.1093/annonc/mdu496]).

In a prospective, multinational, randomized, phase II trial, investigators compared the efficacy of gastric cancer treatments with docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX). Researchers determined the “optimal dose” for each regimen, after which a total of 254 patients – all of whom were aged at least 18 years, with Karnofsky Performance Status scores greater than 70, histologically proven metastatic or locally recurrent gastric adenocarcinoma – were randomized using “an interactive voice response system, with stratification by country, weight loss (≤5% or >5%), and disease measurability.”

Ultimately, 248 patients received full treatments of one of the three optimized dose regimens. Investigators took note of both PFS and OS rates, both of which had higher medians in the TEF group than in either the TE or the TEX: 7.66 months TEF versus 4.50 months TE and 5.55 months TEX for PFS and 14.59 months TEF versus 8.97 months TE and 11.30 months TEX for OS. Tumor response rates, complete or partial, were also higher in the TEF group: 46.6% versus 23.1% for TE and 25.6% for TEX. In terms of adverse effects and the frequency of such occurrences, the numbers were similar across all three groups. The most commonly reported side effects were fatigue (21%), sensory neuropathy (14%), and diarrhea (13%).

In order to account for potential toxicity, which would offset patient survival data, the investigators used a therapeutic index relating their PFS data to a measure of tolerability of febrile neutropenia, which was reported in all three groups: 2% TEF, 14% TE, and 9% TEX.

“Using this index, TEF was very favorable, compared with TE and TEX and also with historical data for DCF and CF, thus providing evidence of an improved benefit:risk profile with TEF, compared with the standard treatment in advanced GC,” Dr. Van Cutsem and his coauthors noted.

Dr. Van Cutsem and coauthor Dr. J. Tabernero have received research funding from Sanofi, which also supported the study. Dr. Tabernero has also acted as a consultant for and has received honoraria from Sanofi. All other coauthors reported no financial conflicts of interest.

[email protected]

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

Creatas Images

Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

Creatas Images

Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

Creatas Images

Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

©moodboard/thinkstockphotos.com

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

[email protected]

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

©moodboard/thinkstockphotos.com

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

[email protected]

Children with nonalcoholic fatty liver disease should have their blood pressure evaluated, controlled, and monitored regularly to mitigate long-term risks of liver disease, hypertension, and cardiovascular morbidity and mortality, according to a new study.

“NAFLD [nonalcoholic fatty liver disease] is now the most common cause of chronic liver disease in children in the United States with an estimated prevalence of 9.6%,” wrote lead author Dr. Jeffrey B. Schwimmer of the University of California, San Diego, and his associates, adding that their investigation’s twofold purpose was to determine “the prevalence of high blood pressure in children with NAFLD in relation to demographic and key clinical risk factors, and the rate and risk factors of persistent (over 48 weeks) high blood pressure in children with NAFLD.”

©moodboard/thinkstockphotos.com

For this multicenter, longitudinal cohort study, 448 children aged 2-17 years were enrolled through the National Institute of Diabetes and Digestive and Kidney Diseases Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) between September 2004 and October 2009. Only 382 of the 448 original subjects were monitored and recorded follow-up data after 48 weeks (PLOS ONE 2014 Nov. 24 [doi:10.1371/journal.pone.0112569]).

Diagnosis of NAFLD in these children was based on liver histology, with at least 5% of hepatocytes containing macrovesicular fat, and exclusion of other causes of chronic liver disease by clinical history, laboratory studies, and histology. Baseline analysis excluded children with underlying renal disease, those without a histologic diagnosis of NAFLD, or missing blood pressure at baseline.

Subjects had their physical measurements – height, weight, waist circumference – recorded at enrollment and after 48 weeks, along with their systolic and diastolic blood pressures. High blood pressure at baseline was present in 35.8% of all children, while every one unit increase in body mass index (BMI) increased the odds of a child having high blood pressure by 10%. Children with high blood pressure had a significantly higher mean BMI than did children without high blood pressure (34.6 vs. 31.6 kg/m²). A significant linear relationship between LDL cholesterol and the likelihood of developing high blood pressure also was noted by the investigators (odds ratio, 1.09 per 10 mg/dL).

Children with high blood pressure were significantly more likely to have worse steatosis than were children without high blood pressure (mild, 19.8% vs. 34.2%; moderate, 35.0% vs. 30.7%; severe, 45.2% vs. 35.1%)

Results after 48 weeks indicated that 21% of subjects had persistent high blood pressure and that girls were more predisposed to high blood pressure than boys (28.4% vs. 18.9%), thus increasing their likelihood of developing cardiovascular problems and even liver disease.

“Along with being at an increased risk for cardiovascular disease, we found that children with NAFLD who had high blood pressure were significantly more likely to have more fat in their liver than children without high blood pressure. This could lead to a more serious form of liver disease,” Dr. Schwimmer said in a statement.

There are no “approved and effective” treatments currently available for children with NAFLD, according to the authors, so they urged pediatricians to routinely monitor patients’ blood pressures – particularly those who may be overweight or obese – in order to nip long-term cardiovascular and liver complications in the bud.

“There are some reasons to believe that blood pressure control could be beneficial for NAFLD. Thus, we may be able to decrease the risk of premature cardiovascular disease in these children, and also help their liver,” noted Dr. Schwimmer in a statement. “Parents and doctors need to be aware of the health risks of children who have NAFLD. The sooner high blood pressure is identified and treated in this patient population, the healthier they will be as they transition into adulthood.”

In adults with NAFLD, cardiovascular disease is the leading cause of death.

The study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors said they had no competing interests.

[email protected]

The laparoscopic power morcellator, in wide use for years, should not be used in the “vast majority” of women undergoing a hysterectomy or myomectomy, the Food and Drug Administration announced.

The updated safety communication regarding the use of laparoscopic power morcellators to treat uterine fibroids includes an Immediately in Effect guidance to manufacturers of the devices that the labels should include “specific safety statements” in the form of a boxed warning and two contraindications on proper usage.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

According to the FDA announcement, the boxed warning on future labels should say, “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

The first of the two contraindications, both of which also would be included on all future laparoscopic power morcellator labels, warns against using the devices for removal of uterine tissue that possibly contains fibroids in patients who are perimenopausal or postmenopausal, and candidates for en bloc tissue removal through the vagina or minilaparotomy incision, as these groups of women “represent the majority of women with fibroids who undergo hysterectomy and myomectomy.” The second contraindication cautions against using laparoscopic power morcellators “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” Dr. Maisel said in a statement.

This announcement appears to be stronger than the previous statement, “perhaps geared to those select few who have not ceased using the laparoscopic power morcellator,” Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Gynecologic surgeons must collaborate with medical engineers to create equipment that will enable women to once again enjoy the advantages of minimally invasive techniques that we have worked so hard to develop,” he added. “We have seen an increased number of laparotomies, and thus increased women’s risk for postoperative morbidity. I am hopeful that novel approaches will soon be made available for our patients.”

This latest set of warnings is an update of guidelines originally issued by the FDA in April 2014, in which the federal agency stated that use of laparoscopic power morcellators for hysterectomy or myomectomy can significantly increase the risk of spreading “unsuspected” cancer found in the tissue of the uterine wall. A quantitative analysis released by the FDA estimated that 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.

The agency announced that its Immediately in Effect (IIE) guidance applies to all new and currently marketed laparoscopic power morcellators used for “general and specific gynecological indications.”

The campaign to highlight the risks of morcellators has been led by Dr. Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 leiomyosarcoma after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids. Dr. Noorchashm and Dr. Reed have called for a ban on the use of laparoscopic power morcellators.

Asked to comment on the FDA announcement, Dr. Noorchashm said the decision represents “ a massive and historic regulatory failure on the part of FDA Center for Devices and Radiological Health.”

In an interview, he added, “The evidence of avoidable deadly harm was beyond doubt in this case. But the FDA CDRH could not bring itself to fully protect those at risk. This demonstrates that the FDA is a ‘captured agency’ with more loyalty to corporate and industry interests than to patient safety. I think the United States Congress needs to conduct a hearing and overhaul and clarify the FDA’s overall mission. And in particular medical device safety legislation. Corporations have power, people don’t. And without cogent federal government, lives are left exposed.”

--Elizabeth Mechcatie contributed to this article.

[email protected] 

*This article was updated November 24, 2014.

The laparoscopic power morcellator, in wide use for years, should not be used in the “vast majority” of women undergoing a hysterectomy or myomectomy, the Food and Drug Administration announced.

The updated safety communication regarding the use of laparoscopic power morcellators to treat uterine fibroids includes an Immediately in Effect guidance to manufacturers of the devices that the labels should include “specific safety statements” in the form of a boxed warning and two contraindications on proper usage.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

According to the FDA announcement, the boxed warning on future labels should say, “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

The first of the two contraindications, both of which also would be included on all future laparoscopic power morcellator labels, warns against using the devices for removal of uterine tissue that possibly contains fibroids in patients who are perimenopausal or postmenopausal, and candidates for en bloc tissue removal through the vagina or minilaparotomy incision, as these groups of women “represent the majority of women with fibroids who undergo hysterectomy and myomectomy.” The second contraindication cautions against using laparoscopic power morcellators “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” Dr. Maisel said in a statement.

This announcement appears to be stronger than the previous statement, “perhaps geared to those select few who have not ceased using the laparoscopic power morcellator,” Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Gynecologic surgeons must collaborate with medical engineers to create equipment that will enable women to once again enjoy the advantages of minimally invasive techniques that we have worked so hard to develop,” he added. “We have seen an increased number of laparotomies, and thus increased women’s risk for postoperative morbidity. I am hopeful that novel approaches will soon be made available for our patients.”

This latest set of warnings is an update of guidelines originally issued by the FDA in April 2014, in which the federal agency stated that use of laparoscopic power morcellators for hysterectomy or myomectomy can significantly increase the risk of spreading “unsuspected” cancer found in the tissue of the uterine wall. A quantitative analysis released by the FDA estimated that 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.

The agency announced that its Immediately in Effect (IIE) guidance applies to all new and currently marketed laparoscopic power morcellators used for “general and specific gynecological indications.”

The campaign to highlight the risks of morcellators has been led by Dr. Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 leiomyosarcoma after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids. Dr. Noorchashm and Dr. Reed have called for a ban on the use of laparoscopic power morcellators.

Asked to comment on the FDA announcement, Dr. Noorchashm said the decision represents “ a massive and historic regulatory failure on the part of FDA Center for Devices and Radiological Health.”

In an interview, he added, “The evidence of avoidable deadly harm was beyond doubt in this case. But the FDA CDRH could not bring itself to fully protect those at risk. This demonstrates that the FDA is a ‘captured agency’ with more loyalty to corporate and industry interests than to patient safety. I think the United States Congress needs to conduct a hearing and overhaul and clarify the FDA’s overall mission. And in particular medical device safety legislation. Corporations have power, people don’t. And without cogent federal government, lives are left exposed.”

--Elizabeth Mechcatie contributed to this article.

[email protected] 

*This article was updated November 24, 2014.

The laparoscopic power morcellator, in wide use for years, should not be used in the “vast majority” of women undergoing a hysterectomy or myomectomy, the Food and Drug Administration announced.

The updated safety communication regarding the use of laparoscopic power morcellators to treat uterine fibroids includes an Immediately in Effect guidance to manufacturers of the devices that the labels should include “specific safety statements” in the form of a boxed warning and two contraindications on proper usage.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

According to the FDA announcement, the boxed warning on future labels should say, “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

The first of the two contraindications, both of which also would be included on all future laparoscopic power morcellator labels, warns against using the devices for removal of uterine tissue that possibly contains fibroids in patients who are perimenopausal or postmenopausal, and candidates for en bloc tissue removal through the vagina or minilaparotomy incision, as these groups of women “represent the majority of women with fibroids who undergo hysterectomy and myomectomy.” The second contraindication cautions against using laparoscopic power morcellators “in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.”

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” Dr. Maisel said in a statement.

This announcement appears to be stronger than the previous statement, “perhaps geared to those select few who have not ceased using the laparoscopic power morcellator,” Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview. “Gynecologic surgeons must collaborate with medical engineers to create equipment that will enable women to once again enjoy the advantages of minimally invasive techniques that we have worked so hard to develop,” he added. “We have seen an increased number of laparotomies, and thus increased women’s risk for postoperative morbidity. I am hopeful that novel approaches will soon be made available for our patients.”

This latest set of warnings is an update of guidelines originally issued by the FDA in April 2014, in which the federal agency stated that use of laparoscopic power morcellators for hysterectomy or myomectomy can significantly increase the risk of spreading “unsuspected” cancer found in the tissue of the uterine wall. A quantitative analysis released by the FDA estimated that 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.

The agency announced that its Immediately in Effect (IIE) guidance applies to all new and currently marketed laparoscopic power morcellators used for “general and specific gynecological indications.”

The campaign to highlight the risks of morcellators has been led by Dr. Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Dr. Amy Reed, an anesthesiologist who was diagnosed with stage 4 leiomyosarcoma after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids. Dr. Noorchashm and Dr. Reed have called for a ban on the use of laparoscopic power morcellators.

Asked to comment on the FDA announcement, Dr. Noorchashm said the decision represents “ a massive and historic regulatory failure on the part of FDA Center for Devices and Radiological Health.”

In an interview, he added, “The evidence of avoidable deadly harm was beyond doubt in this case. But the FDA CDRH could not bring itself to fully protect those at risk. This demonstrates that the FDA is a ‘captured agency’ with more loyalty to corporate and industry interests than to patient safety. I think the United States Congress needs to conduct a hearing and overhaul and clarify the FDA’s overall mission. And in particular medical device safety legislation. Corporations have power, people don’t. And without cogent federal government, lives are left exposed.”

--Elizabeth Mechcatie contributed to this article.

[email protected] 

*This article was updated November 24, 2014.