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Chantix Has Most Adverse Events
Varenicline (Chantix) accounted for the largest number of adverse drug reactions reported to the Food and Drug Administration in the first quarter of this year, according to an analysis of agency data by the Institute for Safe Medicine Practices. There were 1,001 reports of injuries and 50 deaths potentially related to the drug; 226 of the reports were self-injury or suicide. The FDA has been “carefully evaluating” the varenicline reports, according to a statement. The agency also confirmed that it has received reports of accidents, including traffic accidents, after varenicline use. ISMP said that overall, there were a record number of serious injuries reported in the first quarter: 20,745 cases. The 4,824 deaths recorded was the highest total since 2004, according to the ISMP, which noted that a small number of drugs accounted for a large volume of reports. Rounding out the top 10 drugs associated with adverse reactions are heparin (specifically a tainted version tied to Chinese suppliers), fentanyl, interferon beta, infliximab, etanercept, clopidogrel, pregabalin, acetaminophen, and oxycodone.
Midlife Whites Top Suicide Risk
The epidemiology of suicide has changed, with middle-aged whites now at highest risk, and hanging and suffocation on the rise, a new study from researchers at Johns Hopkins Bloomberg School of Public Health suggests. The researchers studied mortality data from the federal Web-based Injury Statistics Query and Reporting system. From 1999 to 2005, suicide rates increased for whites aged 40–64 years, but did not rise for any other age or racial group. The overall suicide rate increased 0.7% a year, driven by a 4.9% increase each year in hanging and suffocation, and a 1.8% increase annually in poisonings. Suicide by firearm decreased 1.1% a year, but it was still the dominant method, accounting for 52% of all suicides in 2005. The authors said that of four racial groups, only whites showed a significant increase in suicide, increasing 1.1% per year. The study will appear in the December issue of the American Journal of Preventive Medicine.
Lilly: $1.5 Billion Zyprexa Charge
Eli Lilly & Co. will take close to a $1.5 billion charge against its earnings to account for the resolution of investigations of Zyprexa (olanzapine) by the U.S. Attorney for the Eastern District of Pennsylvania and by 32 states and the District of Columbia. Lilly already said it would pay $62 million to the 32 states to resolve charges that it was engaged in illegal off-label marketing. But there has been no resolution with the U.S. Attorney, or with 11 other states that did not participate in that settlement. The $1.33 per share charge was revealed in its third-quarter earnings report. As a result, Lilly recorded a net loss of $466 million in the third quarter, compared with net income of $926 million in the same quarter in 2007.
Disparities in Mental Health
Three studies in the November issue of Psychiatric Services find persistent and deep disparities in mental health treatment of minorities. The lead study, by Margarita Alegria, Ph.D., and colleagues, found that 63% of Hispanics, 69% of Asians, and 59% of African Americans with depressive disorder in the past year did not access any mental health treatment, compared with 40% of non-Hispanic whites. The authors used pooled data from the National Institute of Mental Health Collaborative Psychiatric Epidemiology Surveys, which has a special emphasis on minorities. They focused on 1,082 respondents with current depression and 7,680 who did not meet criteria for past-year substance abuse or psychiatric disorder. Current depression was more common in whites than in minorities. But overall, all minorities were significantly less likely to receive mental health care than whites were. Some of the factors associated with disparities included a fear among low-income minorities of losing pay during treatment; stigma of mental illness in some racial and ethnic groups; minority distrust of health professionals; and lack of mental health service funding for the uninsured and Medicaid recipients.
GAO: FDA Needed Broader Pool
FDA officials might have avoided some conflicts of interest on their scientific advisory committees by expanding recruitment efforts beyond word-of-mouth nominations, according to a report from the Government Accountability Office. The report analyzed the recruitment and screening of FDA advisory committee members before the agency changed those processes in 2007. The FDA could have reach out beyond its usual source of experts to retired professionals, university professors, and experts in epidemiology and statistics, the GAO concluded. The evaluation was requested by members of the Senate.
Nationwide RAC Launched
The Centers for Medicare and Medicaid Services has launched its national recovery audit contractor program as part of its “aggressive new steps to find and prevent waste, fraud and abuse in Medicare.” The new RACs, which will be paid on a contingent basis, soon will begin to contact providers about the program, the CMS said. The 3-year RAC demonstration program in California, Florida, New York, Massachusetts, South Carolina, and Arizona collected more than $900 million in overpayments, according to the CMS. However, the program has drawn strong criticism from physician groups, who have maintained that RAC audits were overly burdensome. The CMS also said it would begin to work directly with beneficiaries to make certain they receive the durable medical equipment or home health services for which Medicare has been billed, and that the items or services were medically necessary.
Chantix Has Most Adverse Events
Varenicline (Chantix) accounted for the largest number of adverse drug reactions reported to the Food and Drug Administration in the first quarter of this year, according to an analysis of agency data by the Institute for Safe Medicine Practices. There were 1,001 reports of injuries and 50 deaths potentially related to the drug; 226 of the reports were self-injury or suicide. The FDA has been “carefully evaluating” the varenicline reports, according to a statement. The agency also confirmed that it has received reports of accidents, including traffic accidents, after varenicline use. ISMP said that overall, there were a record number of serious injuries reported in the first quarter: 20,745 cases. The 4,824 deaths recorded was the highest total since 2004, according to the ISMP, which noted that a small number of drugs accounted for a large volume of reports. Rounding out the top 10 drugs associated with adverse reactions are heparin (specifically a tainted version tied to Chinese suppliers), fentanyl, interferon beta, infliximab, etanercept, clopidogrel, pregabalin, acetaminophen, and oxycodone.
Midlife Whites Top Suicide Risk
The epidemiology of suicide has changed, with middle-aged whites now at highest risk, and hanging and suffocation on the rise, a new study from researchers at Johns Hopkins Bloomberg School of Public Health suggests. The researchers studied mortality data from the federal Web-based Injury Statistics Query and Reporting system. From 1999 to 2005, suicide rates increased for whites aged 40–64 years, but did not rise for any other age or racial group. The overall suicide rate increased 0.7% a year, driven by a 4.9% increase each year in hanging and suffocation, and a 1.8% increase annually in poisonings. Suicide by firearm decreased 1.1% a year, but it was still the dominant method, accounting for 52% of all suicides in 2005. The authors said that of four racial groups, only whites showed a significant increase in suicide, increasing 1.1% per year. The study will appear in the December issue of the American Journal of Preventive Medicine.
Lilly: $1.5 Billion Zyprexa Charge
Eli Lilly & Co. will take close to a $1.5 billion charge against its earnings to account for the resolution of investigations of Zyprexa (olanzapine) by the U.S. Attorney for the Eastern District of Pennsylvania and by 32 states and the District of Columbia. Lilly already said it would pay $62 million to the 32 states to resolve charges that it was engaged in illegal off-label marketing. But there has been no resolution with the U.S. Attorney, or with 11 other states that did not participate in that settlement. The $1.33 per share charge was revealed in its third-quarter earnings report. As a result, Lilly recorded a net loss of $466 million in the third quarter, compared with net income of $926 million in the same quarter in 2007.
Disparities in Mental Health
Three studies in the November issue of Psychiatric Services find persistent and deep disparities in mental health treatment of minorities. The lead study, by Margarita Alegria, Ph.D., and colleagues, found that 63% of Hispanics, 69% of Asians, and 59% of African Americans with depressive disorder in the past year did not access any mental health treatment, compared with 40% of non-Hispanic whites. The authors used pooled data from the National Institute of Mental Health Collaborative Psychiatric Epidemiology Surveys, which has a special emphasis on minorities. They focused on 1,082 respondents with current depression and 7,680 who did not meet criteria for past-year substance abuse or psychiatric disorder. Current depression was more common in whites than in minorities. But overall, all minorities were significantly less likely to receive mental health care than whites were. Some of the factors associated with disparities included a fear among low-income minorities of losing pay during treatment; stigma of mental illness in some racial and ethnic groups; minority distrust of health professionals; and lack of mental health service funding for the uninsured and Medicaid recipients.
GAO: FDA Needed Broader Pool
FDA officials might have avoided some conflicts of interest on their scientific advisory committees by expanding recruitment efforts beyond word-of-mouth nominations, according to a report from the Government Accountability Office. The report analyzed the recruitment and screening of FDA advisory committee members before the agency changed those processes in 2007. The FDA could have reach out beyond its usual source of experts to retired professionals, university professors, and experts in epidemiology and statistics, the GAO concluded. The evaluation was requested by members of the Senate.
Nationwide RAC Launched
The Centers for Medicare and Medicaid Services has launched its national recovery audit contractor program as part of its “aggressive new steps to find and prevent waste, fraud and abuse in Medicare.” The new RACs, which will be paid on a contingent basis, soon will begin to contact providers about the program, the CMS said. The 3-year RAC demonstration program in California, Florida, New York, Massachusetts, South Carolina, and Arizona collected more than $900 million in overpayments, according to the CMS. However, the program has drawn strong criticism from physician groups, who have maintained that RAC audits were overly burdensome. The CMS also said it would begin to work directly with beneficiaries to make certain they receive the durable medical equipment or home health services for which Medicare has been billed, and that the items or services were medically necessary.
Chantix Has Most Adverse Events
Varenicline (Chantix) accounted for the largest number of adverse drug reactions reported to the Food and Drug Administration in the first quarter of this year, according to an analysis of agency data by the Institute for Safe Medicine Practices. There were 1,001 reports of injuries and 50 deaths potentially related to the drug; 226 of the reports were self-injury or suicide. The FDA has been “carefully evaluating” the varenicline reports, according to a statement. The agency also confirmed that it has received reports of accidents, including traffic accidents, after varenicline use. ISMP said that overall, there were a record number of serious injuries reported in the first quarter: 20,745 cases. The 4,824 deaths recorded was the highest total since 2004, according to the ISMP, which noted that a small number of drugs accounted for a large volume of reports. Rounding out the top 10 drugs associated with adverse reactions are heparin (specifically a tainted version tied to Chinese suppliers), fentanyl, interferon beta, infliximab, etanercept, clopidogrel, pregabalin, acetaminophen, and oxycodone.
Midlife Whites Top Suicide Risk
The epidemiology of suicide has changed, with middle-aged whites now at highest risk, and hanging and suffocation on the rise, a new study from researchers at Johns Hopkins Bloomberg School of Public Health suggests. The researchers studied mortality data from the federal Web-based Injury Statistics Query and Reporting system. From 1999 to 2005, suicide rates increased for whites aged 40–64 years, but did not rise for any other age or racial group. The overall suicide rate increased 0.7% a year, driven by a 4.9% increase each year in hanging and suffocation, and a 1.8% increase annually in poisonings. Suicide by firearm decreased 1.1% a year, but it was still the dominant method, accounting for 52% of all suicides in 2005. The authors said that of four racial groups, only whites showed a significant increase in suicide, increasing 1.1% per year. The study will appear in the December issue of the American Journal of Preventive Medicine.
Lilly: $1.5 Billion Zyprexa Charge
Eli Lilly & Co. will take close to a $1.5 billion charge against its earnings to account for the resolution of investigations of Zyprexa (olanzapine) by the U.S. Attorney for the Eastern District of Pennsylvania and by 32 states and the District of Columbia. Lilly already said it would pay $62 million to the 32 states to resolve charges that it was engaged in illegal off-label marketing. But there has been no resolution with the U.S. Attorney, or with 11 other states that did not participate in that settlement. The $1.33 per share charge was revealed in its third-quarter earnings report. As a result, Lilly recorded a net loss of $466 million in the third quarter, compared with net income of $926 million in the same quarter in 2007.
Disparities in Mental Health
Three studies in the November issue of Psychiatric Services find persistent and deep disparities in mental health treatment of minorities. The lead study, by Margarita Alegria, Ph.D., and colleagues, found that 63% of Hispanics, 69% of Asians, and 59% of African Americans with depressive disorder in the past year did not access any mental health treatment, compared with 40% of non-Hispanic whites. The authors used pooled data from the National Institute of Mental Health Collaborative Psychiatric Epidemiology Surveys, which has a special emphasis on minorities. They focused on 1,082 respondents with current depression and 7,680 who did not meet criteria for past-year substance abuse or psychiatric disorder. Current depression was more common in whites than in minorities. But overall, all minorities were significantly less likely to receive mental health care than whites were. Some of the factors associated with disparities included a fear among low-income minorities of losing pay during treatment; stigma of mental illness in some racial and ethnic groups; minority distrust of health professionals; and lack of mental health service funding for the uninsured and Medicaid recipients.
GAO: FDA Needed Broader Pool
FDA officials might have avoided some conflicts of interest on their scientific advisory committees by expanding recruitment efforts beyond word-of-mouth nominations, according to a report from the Government Accountability Office. The report analyzed the recruitment and screening of FDA advisory committee members before the agency changed those processes in 2007. The FDA could have reach out beyond its usual source of experts to retired professionals, university professors, and experts in epidemiology and statistics, the GAO concluded. The evaluation was requested by members of the Senate.
Nationwide RAC Launched
The Centers for Medicare and Medicaid Services has launched its national recovery audit contractor program as part of its “aggressive new steps to find and prevent waste, fraud and abuse in Medicare.” The new RACs, which will be paid on a contingent basis, soon will begin to contact providers about the program, the CMS said. The 3-year RAC demonstration program in California, Florida, New York, Massachusetts, South Carolina, and Arizona collected more than $900 million in overpayments, according to the CMS. However, the program has drawn strong criticism from physician groups, who have maintained that RAC audits were overly burdensome. The CMS also said it would begin to work directly with beneficiaries to make certain they receive the durable medical equipment or home health services for which Medicare has been billed, and that the items or services were medically necessary.