Elizabeth Mechcatie

A glucose monitor that can be monitored remotely from another room and is intended for use with a specific insulin pump has been approved by the Food and Drug Administration, the manufacturer, Medtronic, has announced.

A press release issued by the company said that the glucose monitor enables parents or caregivers to monitor the status of an individual's insulin pump and glucose trends, with alerts and alarms that can alert them at their bedside if, for example, the glucose levels of a child or adult sleeping in another room are dropping in the middle of the night.

The device is being marketed as the “mySentry Remote Glucose Monitor,” and is used with the MiniMed Paradigm Real-Time Revel System, an insulin pump with a continuous glucose monitor, the Medtronic statement said. At press time, there was no notice of the approval on the FDA's website.

A glucose monitor that can be monitored remotely from another room and is intended for use with a specific insulin pump has been approved by the Food and Drug Administration, the manufacturer, Medtronic, has announced.

A press release issued by the company said that the glucose monitor enables parents or caregivers to monitor the status of an individual's insulin pump and glucose trends, with alerts and alarms that can alert them at their bedside if, for example, the glucose levels of a child or adult sleeping in another room are dropping in the middle of the night.

The device is being marketed as the “mySentry Remote Glucose Monitor,” and is used with the MiniMed Paradigm Real-Time Revel System, an insulin pump with a continuous glucose monitor, the Medtronic statement said. At press time, there was no notice of the approval on the FDA's website.

A glucose monitor that can be monitored remotely from another room and is intended for use with a specific insulin pump has been approved by the Food and Drug Administration, the manufacturer, Medtronic, has announced.

A press release issued by the company said that the glucose monitor enables parents or caregivers to monitor the status of an individual's insulin pump and glucose trends, with alerts and alarms that can alert them at their bedside if, for example, the glucose levels of a child or adult sleeping in another room are dropping in the middle of the night.

The device is being marketed as the “mySentry Remote Glucose Monitor,” and is used with the MiniMed Paradigm Real-Time Revel System, an insulin pump with a continuous glucose monitor, the Medtronic statement said. At press time, there was no notice of the approval on the FDA's website.

Axitinib, a kinase inhibitor, received approval for the treatment of advanced renal cell cancer and is the seventh drug approved for metastatic or advanced kidney cell cancer since 2005, the Food and Drug Administration announced on Jan. 27.

"Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options," Dr. Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the FDA statement.

The approved indication for axitinib is for the treatment of advanced renal cell carcinoma (RCC) "after failure of one prior systemic therapy." Approval was based on a single randomized, open-label, multicenter clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy, according to the FDA statement.

In the study, median progression-free survival was 6.7 months among those treated with axitinib, compared with 4.7 months for those treated with sorafenib, a standard treatment for the disease. Both sorafenib (Nexavar), approved in 2005, and axitinib are selective inhibitors of vascular endothelial growth factor (VEGF) and are administered orally twice a day.

Axitinib has an antiangiogenic effect. It inhibits the proangiogenic cytokines vascular endothelial growth factor (VEGF) and platelet-derived growth factor receptors (PDGF), according to the National Cancer Institute.

Axitinib will be marketed as Inlyta by Pfizer. Axitinib inhibits receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

The other targeted treatments for advanced RCC that have been approved are VEGF-receptor inhibitors sunitinib (Sutent) and pazopanib (Votrient), the anti-VEGF antibody bevacizumab (Avastin), and the mammalian target of rapamycin (mTOR) inhibitors temsirolimus (Torisel) and everolimus (Afinitor).

The most common side effects reported to occur among more than 20% of patients treated with axitinib included diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, asthenia, and constipation.

The warnings and precautions section of the label advises that blood pressure should be well controlled before patients start treatment with axitinib and should be monitored during treatment.

At a meeting on Dec. 7, 2011, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended that axitinib be approved for advanced RCC, based on the study findings, although the efficacy findings were driven primarily by the results among patients previously treated with cytokines, a population less likely to be seen in the United States.

Axitinib, a kinase inhibitor, received approval for the treatment of advanced renal cell cancer and is the seventh drug approved for metastatic or advanced kidney cell cancer since 2005, the Food and Drug Administration announced on Jan. 27.

"Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options," Dr. Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the FDA statement.

The approved indication for axitinib is for the treatment of advanced renal cell carcinoma (RCC) "after failure of one prior systemic therapy." Approval was based on a single randomized, open-label, multicenter clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy, according to the FDA statement.

In the study, median progression-free survival was 6.7 months among those treated with axitinib, compared with 4.7 months for those treated with sorafenib, a standard treatment for the disease. Both sorafenib (Nexavar), approved in 2005, and axitinib are selective inhibitors of vascular endothelial growth factor (VEGF) and are administered orally twice a day.

Axitinib has an antiangiogenic effect. It inhibits the proangiogenic cytokines vascular endothelial growth factor (VEGF) and platelet-derived growth factor receptors (PDGF), according to the National Cancer Institute.

Axitinib will be marketed as Inlyta by Pfizer. Axitinib inhibits receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

The other targeted treatments for advanced RCC that have been approved are VEGF-receptor inhibitors sunitinib (Sutent) and pazopanib (Votrient), the anti-VEGF antibody bevacizumab (Avastin), and the mammalian target of rapamycin (mTOR) inhibitors temsirolimus (Torisel) and everolimus (Afinitor).

The most common side effects reported to occur among more than 20% of patients treated with axitinib included diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, asthenia, and constipation.

The warnings and precautions section of the label advises that blood pressure should be well controlled before patients start treatment with axitinib and should be monitored during treatment.

At a meeting on Dec. 7, 2011, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended that axitinib be approved for advanced RCC, based on the study findings, although the efficacy findings were driven primarily by the results among patients previously treated with cytokines, a population less likely to be seen in the United States.

Axitinib, a kinase inhibitor, received approval for the treatment of advanced renal cell cancer and is the seventh drug approved for metastatic or advanced kidney cell cancer since 2005, the Food and Drug Administration announced on Jan. 27.

"Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options," Dr. Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the FDA statement.

The approved indication for axitinib is for the treatment of advanced renal cell carcinoma (RCC) "after failure of one prior systemic therapy." Approval was based on a single randomized, open-label, multicenter clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy, according to the FDA statement.

In the study, median progression-free survival was 6.7 months among those treated with axitinib, compared with 4.7 months for those treated with sorafenib, a standard treatment for the disease. Both sorafenib (Nexavar), approved in 2005, and axitinib are selective inhibitors of vascular endothelial growth factor (VEGF) and are administered orally twice a day.

Axitinib has an antiangiogenic effect. It inhibits the proangiogenic cytokines vascular endothelial growth factor (VEGF) and platelet-derived growth factor receptors (PDGF), according to the National Cancer Institute.

Axitinib will be marketed as Inlyta by Pfizer. Axitinib inhibits receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

The other targeted treatments for advanced RCC that have been approved are VEGF-receptor inhibitors sunitinib (Sutent) and pazopanib (Votrient), the anti-VEGF antibody bevacizumab (Avastin), and the mammalian target of rapamycin (mTOR) inhibitors temsirolimus (Torisel) and everolimus (Afinitor).

The most common side effects reported to occur among more than 20% of patients treated with axitinib included diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, asthenia, and constipation.

The warnings and precautions section of the label advises that blood pressure should be well controlled before patients start treatment with axitinib and should be monitored during treatment.

At a meeting on Dec. 7, 2011, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended that axitinib be approved for advanced RCC, based on the study findings, although the efficacy findings were driven primarily by the results among patients previously treated with cytokines, a population less likely to be seen in the United States.

The Food and Drug Administration has approved a subcutaneous formulation of bortezomib, which will join the intravenous formulation as treatment for multiple myeloma and mantle cell lymphoma after at least one prior therapy, according to its manufacturer, Millennium: The Takeda Oncology Co.

Bortezomib is a proteasome inhibitor marketed as Velcade; the intravenous formulation was approved in 2003.

Approval of the subcutaneous formulation was based on a randomized, phase III open label noninferiority international study of patients with relapsed multiple myeloma, who had not received bortezomib previously. The study compared the overall response rate (ORR) after four treatment cycles in those treated with the subcutaneous formulation (145) and those treated with the IV formulation (73 patients); noninferiority was defined as retaining 60% of the IV treatment effect. After four cycles, the ORR was 43% among those on the subcutaneous formulation and 42% among those on the IV formulation. These results were published in May (Lancet Oncol. 2011;12:431-40).

Overall, the safety profile for the two arms was similar except for some serious adverse events, including peripheral neuropathy (PN): The rate of PN that was grade 3 or greater was 6% among those on the subcutaneous formulation, compared with 16% among those on the IV formulation, a significant difference. The rate of PN of any grade was also lower among those on the subcutaneous formulation (38% vs. 53%).

Other adverse events that were grade 3 and greater that were at least 5% higher among those on the IV formulation on were thrombocytopenia (6% vs. 16%), thrombocytopenia (13% vs. 19%), and neuralgia (3% vs. 9%).

A contraindication against intrathecal administration of bortezomib has been added to the label, because of fatal events that have resulted from inadvertent intrathecal administration of the drug.

The study was funded by Johnson & Johnson Pharmaceutical Research and Development and Millennium Pharmaceuticals.

The Food and Drug Administration has approved a subcutaneous formulation of bortezomib, which will join the intravenous formulation as treatment for multiple myeloma and mantle cell lymphoma after at least one prior therapy, according to its manufacturer, Millennium: The Takeda Oncology Co.

Bortezomib is a proteasome inhibitor marketed as Velcade; the intravenous formulation was approved in 2003.

Approval of the subcutaneous formulation was based on a randomized, phase III open label noninferiority international study of patients with relapsed multiple myeloma, who had not received bortezomib previously. The study compared the overall response rate (ORR) after four treatment cycles in those treated with the subcutaneous formulation (145) and those treated with the IV formulation (73 patients); noninferiority was defined as retaining 60% of the IV treatment effect. After four cycles, the ORR was 43% among those on the subcutaneous formulation and 42% among those on the IV formulation. These results were published in May (Lancet Oncol. 2011;12:431-40).

Overall, the safety profile for the two arms was similar except for some serious adverse events, including peripheral neuropathy (PN): The rate of PN that was grade 3 or greater was 6% among those on the subcutaneous formulation, compared with 16% among those on the IV formulation, a significant difference. The rate of PN of any grade was also lower among those on the subcutaneous formulation (38% vs. 53%).

Other adverse events that were grade 3 and greater that were at least 5% higher among those on the IV formulation on were thrombocytopenia (6% vs. 16%), thrombocytopenia (13% vs. 19%), and neuralgia (3% vs. 9%).

A contraindication against intrathecal administration of bortezomib has been added to the label, because of fatal events that have resulted from inadvertent intrathecal administration of the drug.

The study was funded by Johnson & Johnson Pharmaceutical Research and Development and Millennium Pharmaceuticals.

The Food and Drug Administration has approved a subcutaneous formulation of bortezomib, which will join the intravenous formulation as treatment for multiple myeloma and mantle cell lymphoma after at least one prior therapy, according to its manufacturer, Millennium: The Takeda Oncology Co.

Bortezomib is a proteasome inhibitor marketed as Velcade; the intravenous formulation was approved in 2003.

Approval of the subcutaneous formulation was based on a randomized, phase III open label noninferiority international study of patients with relapsed multiple myeloma, who had not received bortezomib previously. The study compared the overall response rate (ORR) after four treatment cycles in those treated with the subcutaneous formulation (145) and those treated with the IV formulation (73 patients); noninferiority was defined as retaining 60% of the IV treatment effect. After four cycles, the ORR was 43% among those on the subcutaneous formulation and 42% among those on the IV formulation. These results were published in May (Lancet Oncol. 2011;12:431-40).

Overall, the safety profile for the two arms was similar except for some serious adverse events, including peripheral neuropathy (PN): The rate of PN that was grade 3 or greater was 6% among those on the subcutaneous formulation, compared with 16% among those on the IV formulation, a significant difference. The rate of PN of any grade was also lower among those on the subcutaneous formulation (38% vs. 53%).

Other adverse events that were grade 3 and greater that were at least 5% higher among those on the IV formulation on were thrombocytopenia (6% vs. 16%), thrombocytopenia (13% vs. 19%), and neuralgia (3% vs. 9%).

A contraindication against intrathecal administration of bortezomib has been added to the label, because of fatal events that have resulted from inadvertent intrathecal administration of the drug.

The study was funded by Johnson & Johnson Pharmaceutical Research and Development and Millennium Pharmaceuticals.

U.S. cancer screening rates in 2010 were below national targets for 2020, particularly among Asians and Hispanics, according to a report issued Jan. 26 by the Centers for Disease Control and Prevention and the National Cancer Institute.

"It is troubling to see that not all Americans are getting the recommended cancer screenings, and that disparities continue to persist for certain populations," Dr. Sallyann Coleman King, the study’s lead author and an epidemic intelligence service officer in the CDC’s Division of Cancer Prevention and Control, said in a statement.

National Institutes of Health/Department of Health and Human Services

The study’s authors used data from the 2010 National Health Interview Survey, which is monitoring progress toward the screening goals in Healthy People 2020 (MMWR Morb. Mortal. Wkly. Rep. 2012;61:41-5). That initiative has set objectives for improving the health of Americans – including the use of screening tests for breast, cervical, and colorectal cancer, as recommended by the U.S. Preventive Services Task Force.

This is the first federal study that has identified disparities in cancer screening rates among Asian and Hispanic groups, according to the CDC.

The results illustrate "the particular need for finding ways to increase the use of breast, cervical, and colorectal cancer screening tests among Asians, Hispanics, as well as adults who lack health insurance or a usual source of health care," noted study coauthor Carrie Klabunde, Ph.D., an epidemiologist in the NCI’s Division of Cancer Control and Population Sciences.

The Health People 2020 screening goals for breast, cervical, and colorectal cancer are:

– 81.1% of women aged 50-74 years undergo breast cancer screening via mammography every 2 years.

– 93% of women aged 21-65 years with a cervix undergo Pap smear testing every 3 years to screen for cervical cancer and precancerous lesions.

– 70.5% of both men and women are screened regularly for colorectal cancer between the ages of 50 years and 75 years.

In the new study, Dr. King and her associates found that:

– The overall rate of breast cancer screening was 72.4%. Between 2000 and 2010, screening rates for breast cancer were "relatively stable," according to the CDC, with no more than a 3% variation during that time.

– The overall rate of cervical cancer screening was 83%. However, during the decade, the rate of women who said they had had a Pap test within the previous 3 years dropped by 3.3% – a small but statistically significant reduction.

– The overall rate of colorectal cancer screening among men and women was 58.6%. During the 2000-2010 period, colorectal cancer screening rates "increased markedly" for both sexes, and were almost identical for men (58.5%) and women (58.8%). The rate for women had increased slightly faster during the decade, to catch up with the rate for men.

Among Asians (Chinese, Filipino, or other Asians), screening rates for all three cancers were significantly lower: 64.1% for breast cancer, 75.4% for cervical cancer, and 46.9% for colorectal cancer. Among Hispanics (Puerto Rican, Mexican, Mexican-American, Central or South American, or other Hispanics), the screening rates were lower for cervical (78.7%) and for colorectal cancer (46.5%), compared with non-Hispanics (83.8% and 59.9%, respectively).

Not having a usual source of health care or health insurance was associated with "considerably" lower rates for screening of all three cancers.

Among women with no usual source of health care or no health insurance, mammography rates were much lower, at about 36%-38%. And although immigrant women who had lived in the United States for a decade were nearly as likely as were women born in the United States to have had a mammogram (about two-thirds), 46.6% of women who had lived in the United States for less than 10 years said they had been screened in the previous 2 years.

While financial barriers to screening "might explain some of the disparities in cancer screening rates," the report referred to national programs that provide free or low-cost breast, cervical, and colorectal screening. The study’s authors also noted that the Affordable Health Care Act is expected to help people who can’t afford screening by expanding insurance coverage.

"Efforts should be made to improve screening rates in all population groups," including targeted efforts for groups with particularly low screening rates, the report authors said. In addition, "other efforts are needed, such as developing systems that identify persons eligible for cancer screening tests, actively encouraging the use of screening tests, and monitoring participation to improve screening rates."

The study authors provided no disclosure information.

U.S. cancer screening rates in 2010 were below national targets for 2020, particularly among Asians and Hispanics, according to a report issued Jan. 26 by the Centers for Disease Control and Prevention and the National Cancer Institute.

"It is troubling to see that not all Americans are getting the recommended cancer screenings, and that disparities continue to persist for certain populations," Dr. Sallyann Coleman King, the study’s lead author and an epidemic intelligence service officer in the CDC’s Division of Cancer Prevention and Control, said in a statement.

National Institutes of Health/Department of Health and Human Services

The study’s authors used data from the 2010 National Health Interview Survey, which is monitoring progress toward the screening goals in Healthy People 2020 (MMWR Morb. Mortal. Wkly. Rep. 2012;61:41-5). That initiative has set objectives for improving the health of Americans – including the use of screening tests for breast, cervical, and colorectal cancer, as recommended by the U.S. Preventive Services Task Force.

This is the first federal study that has identified disparities in cancer screening rates among Asian and Hispanic groups, according to the CDC.

The results illustrate "the particular need for finding ways to increase the use of breast, cervical, and colorectal cancer screening tests among Asians, Hispanics, as well as adults who lack health insurance or a usual source of health care," noted study coauthor Carrie Klabunde, Ph.D., an epidemiologist in the NCI’s Division of Cancer Control and Population Sciences.

The Health People 2020 screening goals for breast, cervical, and colorectal cancer are:

– 81.1% of women aged 50-74 years undergo breast cancer screening via mammography every 2 years.

– 93% of women aged 21-65 years with a cervix undergo Pap smear testing every 3 years to screen for cervical cancer and precancerous lesions.

– 70.5% of both men and women are screened regularly for colorectal cancer between the ages of 50 years and 75 years.

In the new study, Dr. King and her associates found that:

– The overall rate of breast cancer screening was 72.4%. Between 2000 and 2010, screening rates for breast cancer were "relatively stable," according to the CDC, with no more than a 3% variation during that time.

– The overall rate of cervical cancer screening was 83%. However, during the decade, the rate of women who said they had had a Pap test within the previous 3 years dropped by 3.3% – a small but statistically significant reduction.

– The overall rate of colorectal cancer screening among men and women was 58.6%. During the 2000-2010 period, colorectal cancer screening rates "increased markedly" for both sexes, and were almost identical for men (58.5%) and women (58.8%). The rate for women had increased slightly faster during the decade, to catch up with the rate for men.

Among Asians (Chinese, Filipino, or other Asians), screening rates for all three cancers were significantly lower: 64.1% for breast cancer, 75.4% for cervical cancer, and 46.9% for colorectal cancer. Among Hispanics (Puerto Rican, Mexican, Mexican-American, Central or South American, or other Hispanics), the screening rates were lower for cervical (78.7%) and for colorectal cancer (46.5%), compared with non-Hispanics (83.8% and 59.9%, respectively).

Not having a usual source of health care or health insurance was associated with "considerably" lower rates for screening of all three cancers.

Among women with no usual source of health care or no health insurance, mammography rates were much lower, at about 36%-38%. And although immigrant women who had lived in the United States for a decade were nearly as likely as were women born in the United States to have had a mammogram (about two-thirds), 46.6% of women who had lived in the United States for less than 10 years said they had been screened in the previous 2 years.

While financial barriers to screening "might explain some of the disparities in cancer screening rates," the report referred to national programs that provide free or low-cost breast, cervical, and colorectal screening. The study’s authors also noted that the Affordable Health Care Act is expected to help people who can’t afford screening by expanding insurance coverage.

"Efforts should be made to improve screening rates in all population groups," including targeted efforts for groups with particularly low screening rates, the report authors said. In addition, "other efforts are needed, such as developing systems that identify persons eligible for cancer screening tests, actively encouraging the use of screening tests, and monitoring participation to improve screening rates."

The study authors provided no disclosure information.

U.S. cancer screening rates in 2010 were below national targets for 2020, particularly among Asians and Hispanics, according to a report issued Jan. 26 by the Centers for Disease Control and Prevention and the National Cancer Institute.

"It is troubling to see that not all Americans are getting the recommended cancer screenings, and that disparities continue to persist for certain populations," Dr. Sallyann Coleman King, the study’s lead author and an epidemic intelligence service officer in the CDC’s Division of Cancer Prevention and Control, said in a statement.

National Institutes of Health/Department of Health and Human Services

The study’s authors used data from the 2010 National Health Interview Survey, which is monitoring progress toward the screening goals in Healthy People 2020 (MMWR Morb. Mortal. Wkly. Rep. 2012;61:41-5). That initiative has set objectives for improving the health of Americans – including the use of screening tests for breast, cervical, and colorectal cancer, as recommended by the U.S. Preventive Services Task Force.

This is the first federal study that has identified disparities in cancer screening rates among Asian and Hispanic groups, according to the CDC.

The results illustrate "the particular need for finding ways to increase the use of breast, cervical, and colorectal cancer screening tests among Asians, Hispanics, as well as adults who lack health insurance or a usual source of health care," noted study coauthor Carrie Klabunde, Ph.D., an epidemiologist in the NCI’s Division of Cancer Control and Population Sciences.

The Health People 2020 screening goals for breast, cervical, and colorectal cancer are:

– 81.1% of women aged 50-74 years undergo breast cancer screening via mammography every 2 years.

– 93% of women aged 21-65 years with a cervix undergo Pap smear testing every 3 years to screen for cervical cancer and precancerous lesions.

– 70.5% of both men and women are screened regularly for colorectal cancer between the ages of 50 years and 75 years.

In the new study, Dr. King and her associates found that:

– The overall rate of breast cancer screening was 72.4%. Between 2000 and 2010, screening rates for breast cancer were "relatively stable," according to the CDC, with no more than a 3% variation during that time.

– The overall rate of cervical cancer screening was 83%. However, during the decade, the rate of women who said they had had a Pap test within the previous 3 years dropped by 3.3% – a small but statistically significant reduction.

– The overall rate of colorectal cancer screening among men and women was 58.6%. During the 2000-2010 period, colorectal cancer screening rates "increased markedly" for both sexes, and were almost identical for men (58.5%) and women (58.8%). The rate for women had increased slightly faster during the decade, to catch up with the rate for men.

Among Asians (Chinese, Filipino, or other Asians), screening rates for all three cancers were significantly lower: 64.1% for breast cancer, 75.4% for cervical cancer, and 46.9% for colorectal cancer. Among Hispanics (Puerto Rican, Mexican, Mexican-American, Central or South American, or other Hispanics), the screening rates were lower for cervical (78.7%) and for colorectal cancer (46.5%), compared with non-Hispanics (83.8% and 59.9%, respectively).

Not having a usual source of health care or health insurance was associated with "considerably" lower rates for screening of all three cancers.

Among women with no usual source of health care or no health insurance, mammography rates were much lower, at about 36%-38%. And although immigrant women who had lived in the United States for a decade were nearly as likely as were women born in the United States to have had a mammogram (about two-thirds), 46.6% of women who had lived in the United States for less than 10 years said they had been screened in the previous 2 years.

While financial barriers to screening "might explain some of the disparities in cancer screening rates," the report referred to national programs that provide free or low-cost breast, cervical, and colorectal screening. The study’s authors also noted that the Affordable Health Care Act is expected to help people who can’t afford screening by expanding insurance coverage.

"Efforts should be made to improve screening rates in all population groups," including targeted efforts for groups with particularly low screening rates, the report authors said. In addition, "other efforts are needed, such as developing systems that identify persons eligible for cancer screening tests, actively encouraging the use of screening tests, and monitoring participation to improve screening rates."

The study authors provided no disclosure information.

The results of a study of 103 outpatients with residual schizophrenia suggest that spirituality and religiousness might contribute to improved quality of life in patients with this diagnosis and should be considered when caring for these patients, according to the investigators.

"Hence, besides pharmacological and nonpharmacological management for schizophrenia, clinicians should assess the spirituality status and its meaning to an individual patient and should encourage those patients to turn to religion more frequently if they consider it useful to deal with their suffering," concluded Dr. Ruchita Shah and her associates of the psychiatry department at the Postgraduate Institute of Medical Education and Research, Chandigarh (India). The study was published in Psychiatry Research (2011;190:200-5 [doi:10.1016/j.psychres.2011.07.034]).

The study enrolled 103 adults diagnosed with residual schizophrenia who were outpatients at the institute’s psychiatry department. Their mean age was 34 years, the mean age at schizophrenia onset was 23 years, and they had had been diagnosed for a mean of almost 12 years. More than half (62%) were male, 71% were Hindus, and the rest were Sikhs. The mean positive domain score on the Positive and Negative Syndrome Scale (PANSS) was 9, the negative domain score was 17, the general psychopathology score was 23, and the total PANSS score was 49.

Research examining the connections between spirituality and quality of life (QOL) has mainly been in the context of "chronic and life-threatening" diseases such as cancer, HIV infection, heart disease, and spinal cord injury, the investigators wrote. That research has found positive associations between "spiritual well-being" and QOL.

"A gradual consensus appears to be forming that spiritual QOL makes a significant and distinctive contribution to QOL assessment in health, and should be assessed routinely in health care populations," they wrote. But studies looking at the impact of spirituality on QOL in people with chronic mental illnesses are sparse, they noted.

In their study, they used the Hindi translation of the World Health Organization Quality of Life–Spirituality, Religiousness, and Personal Beliefs (WHOQOL-SRPB) Scale to assess these patients. In addition to evaluating the five domains of QOL (physical, psychological, level of independence, social relationships, and environment), this scale includes questions related to spirituality, religiousness, and personal beliefs.

Among the main findings was that the spirituality domain of QOL was significantly related to other QOL domains, including the physical, psychological, and social domains. The results also showed that two facets of the spirituality and religiousness domain of QOL – inner peace and spirituality – significantly contributed to the "variance of all the other domains of QOL." For example, the authors describe inner peace as having "a prominent influence" on other areas of QOL, as well as on general QOL, which "suggests that the most important aspect of the spirituality domain of QOL is inner peace which influences the overall QOL" in people with schizophrenia.

Referring to their results and other studies that also have found an association between spirituality and QOL in patients with other serious diseases, "it can be concluded that spirituality is an important aspect of QOL," they added.

Limitations of the studies included the enrollment of only outpatients with one type of schizophrenia, they said, so the results cannot be applied to other types of patients with schizophrenia, such as those who are hospitalized.

"Our study suggests that the spirituality and religiosity domains of QOL have an important influence on other aspects of QOL of patients with schizophrenia," the authors concluded. In light of this, they advise clinicians to assess the spirituality status and its meaning to each patient and encourage patients to "turn to religion more frequently if they consider it useful in dealing with their suffering."

No disclosures were listed in the study.

The results of a study of 103 outpatients with residual schizophrenia suggest that spirituality and religiousness might contribute to improved quality of life in patients with this diagnosis and should be considered when caring for these patients, according to the investigators.

"Hence, besides pharmacological and nonpharmacological management for schizophrenia, clinicians should assess the spirituality status and its meaning to an individual patient and should encourage those patients to turn to religion more frequently if they consider it useful to deal with their suffering," concluded Dr. Ruchita Shah and her associates of the psychiatry department at the Postgraduate Institute of Medical Education and Research, Chandigarh (India). The study was published in Psychiatry Research (2011;190:200-5 [doi:10.1016/j.psychres.2011.07.034]).

The study enrolled 103 adults diagnosed with residual schizophrenia who were outpatients at the institute’s psychiatry department. Their mean age was 34 years, the mean age at schizophrenia onset was 23 years, and they had had been diagnosed for a mean of almost 12 years. More than half (62%) were male, 71% were Hindus, and the rest were Sikhs. The mean positive domain score on the Positive and Negative Syndrome Scale (PANSS) was 9, the negative domain score was 17, the general psychopathology score was 23, and the total PANSS score was 49.

Research examining the connections between spirituality and quality of life (QOL) has mainly been in the context of "chronic and life-threatening" diseases such as cancer, HIV infection, heart disease, and spinal cord injury, the investigators wrote. That research has found positive associations between "spiritual well-being" and QOL.

"A gradual consensus appears to be forming that spiritual QOL makes a significant and distinctive contribution to QOL assessment in health, and should be assessed routinely in health care populations," they wrote. But studies looking at the impact of spirituality on QOL in people with chronic mental illnesses are sparse, they noted.

In their study, they used the Hindi translation of the World Health Organization Quality of Life–Spirituality, Religiousness, and Personal Beliefs (WHOQOL-SRPB) Scale to assess these patients. In addition to evaluating the five domains of QOL (physical, psychological, level of independence, social relationships, and environment), this scale includes questions related to spirituality, religiousness, and personal beliefs.

Among the main findings was that the spirituality domain of QOL was significantly related to other QOL domains, including the physical, psychological, and social domains. The results also showed that two facets of the spirituality and religiousness domain of QOL – inner peace and spirituality – significantly contributed to the "variance of all the other domains of QOL." For example, the authors describe inner peace as having "a prominent influence" on other areas of QOL, as well as on general QOL, which "suggests that the most important aspect of the spirituality domain of QOL is inner peace which influences the overall QOL" in people with schizophrenia.

Referring to their results and other studies that also have found an association between spirituality and QOL in patients with other serious diseases, "it can be concluded that spirituality is an important aspect of QOL," they added.

Limitations of the studies included the enrollment of only outpatients with one type of schizophrenia, they said, so the results cannot be applied to other types of patients with schizophrenia, such as those who are hospitalized.

"Our study suggests that the spirituality and religiosity domains of QOL have an important influence on other aspects of QOL of patients with schizophrenia," the authors concluded. In light of this, they advise clinicians to assess the spirituality status and its meaning to each patient and encourage patients to "turn to religion more frequently if they consider it useful in dealing with their suffering."

No disclosures were listed in the study.

The results of a study of 103 outpatients with residual schizophrenia suggest that spirituality and religiousness might contribute to improved quality of life in patients with this diagnosis and should be considered when caring for these patients, according to the investigators.

"Hence, besides pharmacological and nonpharmacological management for schizophrenia, clinicians should assess the spirituality status and its meaning to an individual patient and should encourage those patients to turn to religion more frequently if they consider it useful to deal with their suffering," concluded Dr. Ruchita Shah and her associates of the psychiatry department at the Postgraduate Institute of Medical Education and Research, Chandigarh (India). The study was published in Psychiatry Research (2011;190:200-5 [doi:10.1016/j.psychres.2011.07.034]).

The study enrolled 103 adults diagnosed with residual schizophrenia who were outpatients at the institute’s psychiatry department. Their mean age was 34 years, the mean age at schizophrenia onset was 23 years, and they had had been diagnosed for a mean of almost 12 years. More than half (62%) were male, 71% were Hindus, and the rest were Sikhs. The mean positive domain score on the Positive and Negative Syndrome Scale (PANSS) was 9, the negative domain score was 17, the general psychopathology score was 23, and the total PANSS score was 49.

Research examining the connections between spirituality and quality of life (QOL) has mainly been in the context of "chronic and life-threatening" diseases such as cancer, HIV infection, heart disease, and spinal cord injury, the investigators wrote. That research has found positive associations between "spiritual well-being" and QOL.

"A gradual consensus appears to be forming that spiritual QOL makes a significant and distinctive contribution to QOL assessment in health, and should be assessed routinely in health care populations," they wrote. But studies looking at the impact of spirituality on QOL in people with chronic mental illnesses are sparse, they noted.

In their study, they used the Hindi translation of the World Health Organization Quality of Life–Spirituality, Religiousness, and Personal Beliefs (WHOQOL-SRPB) Scale to assess these patients. In addition to evaluating the five domains of QOL (physical, psychological, level of independence, social relationships, and environment), this scale includes questions related to spirituality, religiousness, and personal beliefs.

Among the main findings was that the spirituality domain of QOL was significantly related to other QOL domains, including the physical, psychological, and social domains. The results also showed that two facets of the spirituality and religiousness domain of QOL – inner peace and spirituality – significantly contributed to the "variance of all the other domains of QOL." For example, the authors describe inner peace as having "a prominent influence" on other areas of QOL, as well as on general QOL, which "suggests that the most important aspect of the spirituality domain of QOL is inner peace which influences the overall QOL" in people with schizophrenia.

Referring to their results and other studies that also have found an association between spirituality and QOL in patients with other serious diseases, "it can be concluded that spirituality is an important aspect of QOL," they added.

Limitations of the studies included the enrollment of only outpatients with one type of schizophrenia, they said, so the results cannot be applied to other types of patients with schizophrenia, such as those who are hospitalized.

"Our study suggests that the spirituality and religiosity domains of QOL have an important influence on other aspects of QOL of patients with schizophrenia," the authors concluded. In light of this, they advise clinicians to assess the spirituality status and its meaning to each patient and encourage patients to "turn to religion more frequently if they consider it useful in dealing with their suffering."

No disclosures were listed in the study.

SILVER SPRING, MD. – The majority of a Food and Drug Administration advisory panel recommended against approval of an 8% vaginal formulation of progesterone gel for use in reducing the risk of preterm birth in women with a short cervix.

The Reproductive Health Drugs Advisory Committee on Jan. 20 voted 13 to 4 that the product did not have an acceptable risk-benefit profile and that the manufacturer had not provided sufficient evidence to conclude that the gel reduced the risk of preterm birth in women with a singleton gestation and a short cervix at mid-trimester – the proposed indication.

Panelists were not concerned about safety. But those voting against approval said that while they agreed the treatment appeared to have potential and recognized the need for such a product, they were not convinced that it had been shown effective in the pivotal, international study. The overall results were not robust enough to convince them the treatment was effective in reducing preterm birth, they noted, adding that no benefit was seen in the study participants from the United States.

The study compared progesterone gel 8% with placebo, administered daily, in 450 women with a short cervix (1.0-2.0 cm). All women had singleton pregnancies and enrolled from 19 to almost 24 weeks’ gestation. The rate of preterm birth before 33 weeks’ gestation, the primary end point, was 8.9% among those randomized to receive the gel, compared with 15.2 % among women randomized to placebo. This was a statistically significant difference that represented a 44% reduction in risk, according to the manufacturer, Columbia Laboratories Inc.

In the subgroup of women enrolled in the United States, however, the differences between the two groups in the preterm birth rate was not significant (16.8% in the gel group vs. 19.2% in the placebo group) – a major concern raised by the FDA reviewers. The overall compliance rate among the U.S. women was lower than among those enrolled internationally (23% vs. 2%), which the company said could have affected the results.

The FDA analysis, which adjusted for different factors, did not find a significant effect of the gel in reducing the risk of preterm birth, and raised concerns about the generalizability of the results to the U.S. population and variations of the treatment effect in different countries.

The product is a bioadhesive formulation of progesterone packaged in a prefilled, single use vaginal applicator that delivers 90 mg of progesterone. It has been on the market since 1997 and is approved for use in treating infertility in women with progesterone deficiency; it’s also approved as a treatment for secondary amenorrhea in women who have not responded to a 4% formulation. (For these indications, it is marketed as Crinone, by Watson Pharmaceuticals, which is in a partnership with Columbia Laboratories).

Currently, no product is approved for reducing preterm birth in women with a short cervix, a well-recognized predictor of preterm birth. Last year, an injectable progesterone formulation, hydroxyprogesterone caproate (Makena), was approved to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm singleton birth. That product has been controversial because of its extremely high cost.

The FDA usually follows the recommendations of its advisory panels. 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. – The majority of a Food and Drug Administration advisory panel recommended against approval of an 8% vaginal formulation of progesterone gel for use in reducing the risk of preterm birth in women with a short cervix.

The Reproductive Health Drugs Advisory Committee on Jan. 20 voted 13 to 4 that the product did not have an acceptable risk-benefit profile and that the manufacturer had not provided sufficient evidence to conclude that the gel reduced the risk of preterm birth in women with a singleton gestation and a short cervix at mid-trimester – the proposed indication.

Panelists were not concerned about safety. But those voting against approval said that while they agreed the treatment appeared to have potential and recognized the need for such a product, they were not convinced that it had been shown effective in the pivotal, international study. The overall results were not robust enough to convince them the treatment was effective in reducing preterm birth, they noted, adding that no benefit was seen in the study participants from the United States.

The study compared progesterone gel 8% with placebo, administered daily, in 450 women with a short cervix (1.0-2.0 cm). All women had singleton pregnancies and enrolled from 19 to almost 24 weeks’ gestation. The rate of preterm birth before 33 weeks’ gestation, the primary end point, was 8.9% among those randomized to receive the gel, compared with 15.2 % among women randomized to placebo. This was a statistically significant difference that represented a 44% reduction in risk, according to the manufacturer, Columbia Laboratories Inc.

In the subgroup of women enrolled in the United States, however, the differences between the two groups in the preterm birth rate was not significant (16.8% in the gel group vs. 19.2% in the placebo group) – a major concern raised by the FDA reviewers. The overall compliance rate among the U.S. women was lower than among those enrolled internationally (23% vs. 2%), which the company said could have affected the results.

The FDA analysis, which adjusted for different factors, did not find a significant effect of the gel in reducing the risk of preterm birth, and raised concerns about the generalizability of the results to the U.S. population and variations of the treatment effect in different countries.

The product is a bioadhesive formulation of progesterone packaged in a prefilled, single use vaginal applicator that delivers 90 mg of progesterone. It has been on the market since 1997 and is approved for use in treating infertility in women with progesterone deficiency; it’s also approved as a treatment for secondary amenorrhea in women who have not responded to a 4% formulation. (For these indications, it is marketed as Crinone, by Watson Pharmaceuticals, which is in a partnership with Columbia Laboratories).

Currently, no product is approved for reducing preterm birth in women with a short cervix, a well-recognized predictor of preterm birth. Last year, an injectable progesterone formulation, hydroxyprogesterone caproate (Makena), was approved to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm singleton birth. That product has been controversial because of its extremely high cost.

The FDA usually follows the recommendations of its advisory panels. 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. – The majority of a Food and Drug Administration advisory panel recommended against approval of an 8% vaginal formulation of progesterone gel for use in reducing the risk of preterm birth in women with a short cervix.

The Reproductive Health Drugs Advisory Committee on Jan. 20 voted 13 to 4 that the product did not have an acceptable risk-benefit profile and that the manufacturer had not provided sufficient evidence to conclude that the gel reduced the risk of preterm birth in women with a singleton gestation and a short cervix at mid-trimester – the proposed indication.

Panelists were not concerned about safety. But those voting against approval said that while they agreed the treatment appeared to have potential and recognized the need for such a product, they were not convinced that it had been shown effective in the pivotal, international study. The overall results were not robust enough to convince them the treatment was effective in reducing preterm birth, they noted, adding that no benefit was seen in the study participants from the United States.

The study compared progesterone gel 8% with placebo, administered daily, in 450 women with a short cervix (1.0-2.0 cm). All women had singleton pregnancies and enrolled from 19 to almost 24 weeks’ gestation. The rate of preterm birth before 33 weeks’ gestation, the primary end point, was 8.9% among those randomized to receive the gel, compared with 15.2 % among women randomized to placebo. This was a statistically significant difference that represented a 44% reduction in risk, according to the manufacturer, Columbia Laboratories Inc.

In the subgroup of women enrolled in the United States, however, the differences between the two groups in the preterm birth rate was not significant (16.8% in the gel group vs. 19.2% in the placebo group) – a major concern raised by the FDA reviewers. The overall compliance rate among the U.S. women was lower than among those enrolled internationally (23% vs. 2%), which the company said could have affected the results.

The FDA analysis, which adjusted for different factors, did not find a significant effect of the gel in reducing the risk of preterm birth, and raised concerns about the generalizability of the results to the U.S. population and variations of the treatment effect in different countries.

The product is a bioadhesive formulation of progesterone packaged in a prefilled, single use vaginal applicator that delivers 90 mg of progesterone. It has been on the market since 1997 and is approved for use in treating infertility in women with progesterone deficiency; it’s also approved as a treatment for secondary amenorrhea in women who have not responded to a 4% formulation. (For these indications, it is marketed as Crinone, by Watson Pharmaceuticals, which is in a partnership with Columbia Laboratories).

Currently, no product is approved for reducing preterm birth in women with a short cervix, a well-recognized predictor of preterm birth. Last year, an injectable progesterone formulation, hydroxyprogesterone caproate (Makena), was approved to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm singleton birth. That product has been controversial because of its extremely high cost.

The FDA usually follows the recommendations of its advisory panels. 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.

In 2010, an estimated 20% of adults aged 18 years and older in the United States – almost 46 million adults – had experienced "any mental illness" in the past year, with those aged 18-25 years, women, and the unemployed among the groups most affected, according to a report issued Jan. 19 by the Substance Abuse and Mental Health Services Administration (SAMHSA).

A "relatively high" prevalence rate of mental illness during the previous year, a strong association between mental illness during the previous year and substance abuse, as well as a "substantial unmet need" for mental health care during the previous year are among the key findings, the report concluded.

The report also found that that 8% of adolescents aged 12-17 years (almost 2 million individuals) had experienced a major depressive episode in the past year, and that illicit drug use was more than twofold greater among these adolescents than among those who had not used illicit drugs (37% vs. 18%). In addition, 12% of people in this age group (almost 3 million individuals) had received treatment or counseling for emotional or behavioral problems in an inpatient or outpatient mental health setting. "Feeling depressed" was the most common reason for using these services, in almost 50% of cases, the report said.

The SAMHSA report defined "any mental illness" as having had, at the current time or at any time during the past year, "a diagnosable mental, behavioral, or emotional disorder (excluding developmental and substance use disorders) of sufficient duration to meet diagnostic criteria" specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), regardless of functional impairment. The 20% figure in adults was similar to the rate of the previous year. Nearly 30% of the adults aged 18-25 years and 22% of those aged 26-49 years had had a mental illness in the past year, compared with 14% of those aged 50 years and older. Unemployed people were also more likely to have had a mental illness in the past year (28%), compared with people who worked full time (17%) or part time (23%).

The rate of "serious mental illness" – which was defined the same way as "any mental illness," but one that was "of sufficient duration" to meet diagnostic DSM-IV criteria and had "resulted in serious functional impairment, which substantially interferes with or limits one or more major life activities" – followed a similar pattern.

An estimated 5% of adults aged 18 years and older (about 11.4 million adults) had had a serious mental illness, similar to the rate of the previous year. The rate of serious mental illness was highest among those aged 18-25 years (8%), followed by those aged 26-49 years (6%), compared with 3% of those aged 50 years and older. Almost 8% of unemployed adults had a serious illness, compared with 4% of those who were employed full time and 6% of those who were employed part time.

Women were more likely to be affected than men by any mental illness (23% vs. 17%) and serious mental illness (7% vs. 3%).

Less than 40% of the adults who had experienced any mental illness and almost 61% of those with a serious mental illness had received mental health services during the past year.

Substance abuse was more than threefold higher among adults who had had any mental illness in the past year: 20% of the adults who had had any mental illness and 25% of those who had had a serious mental illness met the criteria for substance abuse or dependence, compared with 6% of those who had not had any mental illness during that time.

Among the other findings included in the report was that almost 4% of adults had had serious thoughts about suicide, similar to the rate of the previous year. The rates were about the same for men and women, but were higher among the younger age groups: 7% in those aged 18-25 years, 4% in those aged 26-49 years, and 2.5% in those aged 50 and older.

"Mental illness is a significant public health problem in itself, but also because it is associated with chronic medical diseases such as cardiovascular disease, diabetes, obesity, and cancer, as well as several risk behaviors including physical inactivity, smoking, excessive drinking, and insufficient sleep," Ileana Arias, Ph.D., principal deputy director of the Centers for Disease Control and Prevention, said in a SAMHSA statement announcing the report on Jan. 19. The report, she added, "provides further evidence that we need to continue efforts to monitor levels of mental illness in the United States in order to effectively prevent this important public health problem and its negative impact on total health."

The results are based on the mental health–related results from the 2010 National Survey on Drug Use and Health (NSDUH), an annual survey of about 67,500 people aged 12 years and older in the United States.

In 2010, an estimated 20% of adults aged 18 years and older in the United States – almost 46 million adults – had experienced "any mental illness" in the past year, with those aged 18-25 years, women, and the unemployed among the groups most affected, according to a report issued Jan. 19 by the Substance Abuse and Mental Health Services Administration (SAMHSA).

A "relatively high" prevalence rate of mental illness during the previous year, a strong association between mental illness during the previous year and substance abuse, as well as a "substantial unmet need" for mental health care during the previous year are among the key findings, the report concluded.

The report also found that that 8% of adolescents aged 12-17 years (almost 2 million individuals) had experienced a major depressive episode in the past year, and that illicit drug use was more than twofold greater among these adolescents than among those who had not used illicit drugs (37% vs. 18%). In addition, 12% of people in this age group (almost 3 million individuals) had received treatment or counseling for emotional or behavioral problems in an inpatient or outpatient mental health setting. "Feeling depressed" was the most common reason for using these services, in almost 50% of cases, the report said.

The SAMHSA report defined "any mental illness" as having had, at the current time or at any time during the past year, "a diagnosable mental, behavioral, or emotional disorder (excluding developmental and substance use disorders) of sufficient duration to meet diagnostic criteria" specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), regardless of functional impairment. The 20% figure in adults was similar to the rate of the previous year. Nearly 30% of the adults aged 18-25 years and 22% of those aged 26-49 years had had a mental illness in the past year, compared with 14% of those aged 50 years and older. Unemployed people were also more likely to have had a mental illness in the past year (28%), compared with people who worked full time (17%) or part time (23%).

The rate of "serious mental illness" – which was defined the same way as "any mental illness," but one that was "of sufficient duration" to meet diagnostic DSM-IV criteria and had "resulted in serious functional impairment, which substantially interferes with or limits one or more major life activities" – followed a similar pattern.

An estimated 5% of adults aged 18 years and older (about 11.4 million adults) had had a serious mental illness, similar to the rate of the previous year. The rate of serious mental illness was highest among those aged 18-25 years (8%), followed by those aged 26-49 years (6%), compared with 3% of those aged 50 years and older. Almost 8% of unemployed adults had a serious illness, compared with 4% of those who were employed full time and 6% of those who were employed part time.

Women were more likely to be affected than men by any mental illness (23% vs. 17%) and serious mental illness (7% vs. 3%).

Less than 40% of the adults who had experienced any mental illness and almost 61% of those with a serious mental illness had received mental health services during the past year.

Substance abuse was more than threefold higher among adults who had had any mental illness in the past year: 20% of the adults who had had any mental illness and 25% of those who had had a serious mental illness met the criteria for substance abuse or dependence, compared with 6% of those who had not had any mental illness during that time.

Among the other findings included in the report was that almost 4% of adults had had serious thoughts about suicide, similar to the rate of the previous year. The rates were about the same for men and women, but were higher among the younger age groups: 7% in those aged 18-25 years, 4% in those aged 26-49 years, and 2.5% in those aged 50 and older.

"Mental illness is a significant public health problem in itself, but also because it is associated with chronic medical diseases such as cardiovascular disease, diabetes, obesity, and cancer, as well as several risk behaviors including physical inactivity, smoking, excessive drinking, and insufficient sleep," Ileana Arias, Ph.D., principal deputy director of the Centers for Disease Control and Prevention, said in a SAMHSA statement announcing the report on Jan. 19. The report, she added, "provides further evidence that we need to continue efforts to monitor levels of mental illness in the United States in order to effectively prevent this important public health problem and its negative impact on total health."

The results are based on the mental health–related results from the 2010 National Survey on Drug Use and Health (NSDUH), an annual survey of about 67,500 people aged 12 years and older in the United States.

In 2010, an estimated 20% of adults aged 18 years and older in the United States – almost 46 million adults – had experienced "any mental illness" in the past year, with those aged 18-25 years, women, and the unemployed among the groups most affected, according to a report issued Jan. 19 by the Substance Abuse and Mental Health Services Administration (SAMHSA).

A "relatively high" prevalence rate of mental illness during the previous year, a strong association between mental illness during the previous year and substance abuse, as well as a "substantial unmet need" for mental health care during the previous year are among the key findings, the report concluded.

The report also found that that 8% of adolescents aged 12-17 years (almost 2 million individuals) had experienced a major depressive episode in the past year, and that illicit drug use was more than twofold greater among these adolescents than among those who had not used illicit drugs (37% vs. 18%). In addition, 12% of people in this age group (almost 3 million individuals) had received treatment or counseling for emotional or behavioral problems in an inpatient or outpatient mental health setting. "Feeling depressed" was the most common reason for using these services, in almost 50% of cases, the report said.

The SAMHSA report defined "any mental illness" as having had, at the current time or at any time during the past year, "a diagnosable mental, behavioral, or emotional disorder (excluding developmental and substance use disorders) of sufficient duration to meet diagnostic criteria" specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), regardless of functional impairment. The 20% figure in adults was similar to the rate of the previous year. Nearly 30% of the adults aged 18-25 years and 22% of those aged 26-49 years had had a mental illness in the past year, compared with 14% of those aged 50 years and older. Unemployed people were also more likely to have had a mental illness in the past year (28%), compared with people who worked full time (17%) or part time (23%).

The rate of "serious mental illness" – which was defined the same way as "any mental illness," but one that was "of sufficient duration" to meet diagnostic DSM-IV criteria and had "resulted in serious functional impairment, which substantially interferes with or limits one or more major life activities" – followed a similar pattern.

An estimated 5% of adults aged 18 years and older (about 11.4 million adults) had had a serious mental illness, similar to the rate of the previous year. The rate of serious mental illness was highest among those aged 18-25 years (8%), followed by those aged 26-49 years (6%), compared with 3% of those aged 50 years and older. Almost 8% of unemployed adults had a serious illness, compared with 4% of those who were employed full time and 6% of those who were employed part time.

Women were more likely to be affected than men by any mental illness (23% vs. 17%) and serious mental illness (7% vs. 3%).

Less than 40% of the adults who had experienced any mental illness and almost 61% of those with a serious mental illness had received mental health services during the past year.

Substance abuse was more than threefold higher among adults who had had any mental illness in the past year: 20% of the adults who had had any mental illness and 25% of those who had had a serious mental illness met the criteria for substance abuse or dependence, compared with 6% of those who had not had any mental illness during that time.

Among the other findings included in the report was that almost 4% of adults had had serious thoughts about suicide, similar to the rate of the previous year. The rates were about the same for men and women, but were higher among the younger age groups: 7% in those aged 18-25 years, 4% in those aged 26-49 years, and 2.5% in those aged 50 and older.

"Mental illness is a significant public health problem in itself, but also because it is associated with chronic medical diseases such as cardiovascular disease, diabetes, obesity, and cancer, as well as several risk behaviors including physical inactivity, smoking, excessive drinking, and insufficient sleep," Ileana Arias, Ph.D., principal deputy director of the Centers for Disease Control and Prevention, said in a SAMHSA statement announcing the report on Jan. 19. The report, she added, "provides further evidence that we need to continue efforts to monitor levels of mental illness in the United States in order to effectively prevent this important public health problem and its negative impact on total health."

The results are based on the mental health–related results from the 2010 National Survey on Drug Use and Health (NSDUH), an annual survey of about 67,500 people aged 12 years and older in the United States.

GAITHERSBURG, MD. – A Food and Drug Administration advisory panel on Jan. 11 unanimously agreed in a 9 to 0 vote that a laparoscopically implanted device designed to treat gastroesophageal reflux disease has a favorable risk-benefit profile, providing patients who do not get adequate relief from antireflux medications an alternative to more invasive surgery,.

The FDA’s Gastroenterology–Urology Devices Panel also voted 9 to 0 that there was "reasonable assurance" that the device, the LINX Reflux Management System, was safe and effective for the indication proposed by the manufacturer: the treatment for people who are "diagnosed with pathologic gastroesophageal reflux disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite anti-reflux therapy." The panel did not vote specifically on whether to recommend approval.

The sterile, single-use device is designed to augment a weak lower esophageal sphincter (LES), and is composed of titanium beads that have a magnetic core, strung together on a titanium wire, which is placed around the gastroesophageal junction at the LES. Because of the magnetic attraction between the beads, the beads rest against each other and help prevent the LES from opening at rest, therefore preventing reflux. But the magnetic attraction is disrupted when the patient swallows, allowing food and liquids to pass into the stomach. Belching and vomiting are possible, because the device does not compress the esophagus.

The manufacturer, Torax Medical Inc., conducted two prospective, uncontrolled studies of 144 patients with chronic GERD symptoms, despite long-term acid suppression treatment, in the United States and Europe. All patients received the implant.

In the pivotal study of 100 patients, 64% had normalization of pH or at least a 50% reduction in pH 12 months after device implantation, which was the primary efficacy end point. This finding was not statistically significant, based on prespecified cirtieria for significance. But the majority of patients showed improvement in scores on a scale that measures the severity of GERD symptoms and were able to reduce their daily proton pump inhibitor dosage by at least 50% at 12 and 24 months, which were secondary end points.

Almost 80% (76) of the patients had a total of 162 adverse events that were related to the device or the procedure, of which dysphagia was the most common, accounting for 76 events, followed by pain in 24 events. Some cases had to be treated with esophageal dilation, and some required device removal.

In the feasibility study of 44 patients, the majority of patients also had improvements in GERD symptoms and PPI use for up to a 3-year follow-up, with dysphagia the most common side effect, requiring two esophageal dilations and one explant.

Panelists recommended that patients be followed up for longer than the 3 years in postmarketing studies proposed by the manufacturer. The device has been available in the United Kingdom and Germany for about 2 years.

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.

GAITHERSBURG, MD. – A Food and Drug Administration advisory panel on Jan. 11 unanimously agreed in a 9 to 0 vote that a laparoscopically implanted device designed to treat gastroesophageal reflux disease has a favorable risk-benefit profile, providing patients who do not get adequate relief from antireflux medications an alternative to more invasive surgery,.

The FDA’s Gastroenterology–Urology Devices Panel also voted 9 to 0 that there was "reasonable assurance" that the device, the LINX Reflux Management System, was safe and effective for the indication proposed by the manufacturer: the treatment for people who are "diagnosed with pathologic gastroesophageal reflux disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite anti-reflux therapy." The panel did not vote specifically on whether to recommend approval.

The sterile, single-use device is designed to augment a weak lower esophageal sphincter (LES), and is composed of titanium beads that have a magnetic core, strung together on a titanium wire, which is placed around the gastroesophageal junction at the LES. Because of the magnetic attraction between the beads, the beads rest against each other and help prevent the LES from opening at rest, therefore preventing reflux. But the magnetic attraction is disrupted when the patient swallows, allowing food and liquids to pass into the stomach. Belching and vomiting are possible, because the device does not compress the esophagus.

The manufacturer, Torax Medical Inc., conducted two prospective, uncontrolled studies of 144 patients with chronic GERD symptoms, despite long-term acid suppression treatment, in the United States and Europe. All patients received the implant.

In the pivotal study of 100 patients, 64% had normalization of pH or at least a 50% reduction in pH 12 months after device implantation, which was the primary efficacy end point. This finding was not statistically significant, based on prespecified cirtieria for significance. But the majority of patients showed improvement in scores on a scale that measures the severity of GERD symptoms and were able to reduce their daily proton pump inhibitor dosage by at least 50% at 12 and 24 months, which were secondary end points.

Almost 80% (76) of the patients had a total of 162 adverse events that were related to the device or the procedure, of which dysphagia was the most common, accounting for 76 events, followed by pain in 24 events. Some cases had to be treated with esophageal dilation, and some required device removal.

In the feasibility study of 44 patients, the majority of patients also had improvements in GERD symptoms and PPI use for up to a 3-year follow-up, with dysphagia the most common side effect, requiring two esophageal dilations and one explant.

Panelists recommended that patients be followed up for longer than the 3 years in postmarketing studies proposed by the manufacturer. The device has been available in the United Kingdom and Germany for about 2 years.

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.

GAITHERSBURG, MD. – A Food and Drug Administration advisory panel on Jan. 11 unanimously agreed in a 9 to 0 vote that a laparoscopically implanted device designed to treat gastroesophageal reflux disease has a favorable risk-benefit profile, providing patients who do not get adequate relief from antireflux medications an alternative to more invasive surgery,.

The FDA’s Gastroenterology–Urology Devices Panel also voted 9 to 0 that there was "reasonable assurance" that the device, the LINX Reflux Management System, was safe and effective for the indication proposed by the manufacturer: the treatment for people who are "diagnosed with pathologic gastroesophageal reflux disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite anti-reflux therapy." The panel did not vote specifically on whether to recommend approval.

The sterile, single-use device is designed to augment a weak lower esophageal sphincter (LES), and is composed of titanium beads that have a magnetic core, strung together on a titanium wire, which is placed around the gastroesophageal junction at the LES. Because of the magnetic attraction between the beads, the beads rest against each other and help prevent the LES from opening at rest, therefore preventing reflux. But the magnetic attraction is disrupted when the patient swallows, allowing food and liquids to pass into the stomach. Belching and vomiting are possible, because the device does not compress the esophagus.

The manufacturer, Torax Medical Inc., conducted two prospective, uncontrolled studies of 144 patients with chronic GERD symptoms, despite long-term acid suppression treatment, in the United States and Europe. All patients received the implant.

In the pivotal study of 100 patients, 64% had normalization of pH or at least a 50% reduction in pH 12 months after device implantation, which was the primary efficacy end point. This finding was not statistically significant, based on prespecified cirtieria for significance. But the majority of patients showed improvement in scores on a scale that measures the severity of GERD symptoms and were able to reduce their daily proton pump inhibitor dosage by at least 50% at 12 and 24 months, which were secondary end points.

Almost 80% (76) of the patients had a total of 162 adverse events that were related to the device or the procedure, of which dysphagia was the most common, accounting for 76 events, followed by pain in 24 events. Some cases had to be treated with esophageal dilation, and some required device removal.

In the feasibility study of 44 patients, the majority of patients also had improvements in GERD symptoms and PPI use for up to a 3-year follow-up, with dysphagia the most common side effect, requiring two esophageal dilations and one explant.

Panelists recommended that patients be followed up for longer than the 3 years in postmarketing studies proposed by the manufacturer. The device has been available in the United Kingdom and Germany for about 2 years.

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.