From Staff Reports

Health Spending Continues to Soar

Health care spending in the United States will continue to grow over the next decade, nearly doubling to $4.1 trillion by 2016, according to an analysis the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. Prescription drug spending will continue to rise, they predict. By 2016, prescription drug spending is expected to reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow down in the coming decade, according to the analysis. However, even with the deceleration, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal that would give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since that time, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, require reduction of nicotine levels, and necessitate bigger and more informative warnings on tobacco products. FDA could not ban nicotine-containing products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data from the collaboratives will also be given to physicians for quality improvement purposes. The project will be managed by the Delmarva Foundation for Medical Care. Data will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Pain

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “Our ongoing clinical work with children in the [Federal Emergency Management Agency] trailers and this latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. There was also a significant emotional strain on parents. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror the results of a similar survey of Louisiana families released last year by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Health Spending Continues to Soar

Health care spending in the United States will continue to grow over the next decade, nearly doubling to $4.1 trillion by 2016, according to an analysis the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. Prescription drug spending will continue to rise, they predict. By 2016, prescription drug spending is expected to reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow down in the coming decade, according to the analysis. However, even with the deceleration, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal that would give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since that time, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, require reduction of nicotine levels, and necessitate bigger and more informative warnings on tobacco products. FDA could not ban nicotine-containing products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data from the collaboratives will also be given to physicians for quality improvement purposes. The project will be managed by the Delmarva Foundation for Medical Care. Data will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Pain

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “Our ongoing clinical work with children in the [Federal Emergency Management Agency] trailers and this latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. There was also a significant emotional strain on parents. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror the results of a similar survey of Louisiana families released last year by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Health Spending Continues to Soar

Health care spending in the United States will continue to grow over the next decade, nearly doubling to $4.1 trillion by 2016, according to an analysis the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. Prescription drug spending will continue to rise, they predict. By 2016, prescription drug spending is expected to reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow down in the coming decade, according to the analysis. However, even with the deceleration, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal that would give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since that time, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, require reduction of nicotine levels, and necessitate bigger and more informative warnings on tobacco products. FDA could not ban nicotine-containing products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data from the collaboratives will also be given to physicians for quality improvement purposes. The project will be managed by the Delmarva Foundation for Medical Care. Data will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Pain

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “Our ongoing clinical work with children in the [Federal Emergency Management Agency] trailers and this latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. There was also a significant emotional strain on parents. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror the results of a similar survey of Louisiana families released last year by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Health Spending Continues to Soar

Health care spending in the United States will nearly double to $4.1 trillion by 2016, according to an analysis by the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. They predict that by 2016, prescription drug spending will reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow in the coming decade, according to the analysis. Even so, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal to give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since then, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, and require reduction of nicotine levels and bigger warnings on tobacco products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data will also be given to physicians for quality improvement purposes, and will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Impact

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “This latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror those of last year's survey of Louisiana families by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Health Spending Continues to Soar

Health care spending in the United States will nearly double to $4.1 trillion by 2016, according to an analysis by the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. They predict that by 2016, prescription drug spending will reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow in the coming decade, according to the analysis. Even so, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal to give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since then, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, and require reduction of nicotine levels and bigger warnings on tobacco products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data will also be given to physicians for quality improvement purposes, and will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Impact

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “This latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror those of last year's survey of Louisiana families by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Health Spending Continues to Soar

Health care spending in the United States will nearly double to $4.1 trillion by 2016, according to an analysis by the Centers for Medicare and Medicaid Services. The analysts project that the average annual growth in health care spending will remain at around 6.9% for the next 10 years. The findings were published in the Feb. 21 Web edition of Health Affairs. They predict that by 2016, prescription drug spending will reach $497.5 billion, more than double the spending for 2006. The rate of growth in physician and clinical spending is expected to slow in the coming decade, according to the analysis. Even so, spending for physician services is expected to reach $819.9 billion by 2016. Physician spending in 2006 is projected at $447 billion. “As the nation moves from more traditional sources of insurance, such as employer-based coverage, to more federal- and state-provided health care, we will continue to face tough questions about how we finance our health care bill,” John Poisal, deputy director of the National Health Statistics Group at CMS, said in a statement.

FDA to Regulate Tobacco?

It seemed like back to the future in Washington on Feb. 15, when Sen. Edward M. Kennedy (D-Mass.) presided at a press briefing announcing a proposal to give the Food and Drug Administration the authority to regulate cigarettes as a drug delivery device. In the mid-1990s, Dr. David Kessler, then FDA commissioner, made a bid to do just that, but lost in a battle that ended at the Supreme Court. Since then, congressional bids to do the same have failed. Sen. Kennedy declared that 2007 is the lucky year. “The likelihood of passage is extremely high,” he said of his bill, which according to cosponsor Sen. John Cornyn (R-Tex.) already has 30 allies, 11 of them Republicans. The bill would give FDA more power to restrict tobacco ads and sales to children in particular, and require reduction of nicotine levels and bigger warnings on tobacco products. President George W. Bush has not shown support, but Sen. Cornyn said he'd encourage him to sign it into law if the bill passes the House and Senate.

Performance Data to Patients

CMS has begun laying the groundwork for the release of physician performance data to Medicare beneficiaries. The release will initially come through four regional collaboratives—Indiana Health Information Exchange, Massachusetts Health Quality Partners, Minnesota Community Measurement, and the Wisconsin Collaborative for Healthcare Quality. The four have agreed to create patient-friendly reports that combine Medicare and private insurance data. CMS said it would bring on two more collaboratives in the near future. Data will also be given to physicians for quality improvement purposes, and will be extracted from AQA-approved quality measures, such as whether physicians measure hemoglobin A_1c levels in diabetic patients twice a year. According to a statement by CMS, the data release is partly in response to President Bush's August 2006 Executive Order encouraging interoperable health information technology, transparency of pricing data and quality information, and use of incentives to promote high-quality, cost-effective care. The order also directed federal agencies to share health quality data with beneficiaries.

Katrina's Long-Term Emotional Impact

Mississippi children and families displaced by Hurricane Katrina continue to have emotional problems, according to a report from Columbia University and the Children's Health Fund. The researchers interviewed 576 adults from randomly selected households displaced by the hurricane and found that more than half of the parents reported that at least one child in the family had experienced emotional or behavioral issues following Katrina, but only 29% had sought some form of professional help. “This latest study suggests that as many as one in three children are already suffering from significant mental health, behavioral, and school-related problems,” Dr. Irwin Redlener, president of the Children's Health Fund, said in a statement. About 62% of caregivers surveyed scored low on a standardized mental health instrument, suggesting high levels of clinical anxiety, depression, and posttraumatic stress disorder. The findings mirror those of last year's survey of Louisiana families by Columbia University and the Children's Health Fund.

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time.

Look for Borderline in Adolescents

Don't dismiss the possibility of comorbid borderline personality disorder in adolescents with severe psychiatric problems, wrote Dr. Andrew M. Chanen of the University of Melbourne, and his colleagues.

Borderline personality disorder (BPD) is diagnosed often in adults, but data in adolescents are limited, they said.

To define the psychiatric symptoms and functional abilities of adolescents with BPD, the researchers interviewed 177 psychiatric outpatients aged 15–18 years. The teens were divided into three groups: 46 patients with BPD, 88 patients with a personality disorder other than BPD, and 43 patients with no personality disorder. Adolescents in the BPD group met at least three of the DSM-IV criteria for BPD (J. Clin. Psychiatry 2007;68:297–306).

The BPD patients had significantly more and greater impairment compared with teens in the other two groups. BPD patients averaged more psychiatric diagnoses than did patients in either of the other two groups, and they were significantly more likely to have mood disorders, substance abuse/dependence, disruptive behavior disorders, and anxiety disorders than were the patients without personality disorders. In addition, teens with BPD were significantly more likely than were those in the other groups to have internalizing and externalizing problems (based on self-reports).

Breast-Feeding and PTSD

Among children who were hospitalized for severe burns or other injuries, those who were breast-fed during infancy experienced significantly fewer symptoms of posttraumatic stress disorder when queried 3 months after the injury, according to results of a poster presentation at the annual meeting of the International Society for Traumatic Stress Studies.

The study involved 29 children hospitalized at Shriners Burns Hospital, Boston, and 73 children hospitalized at Boston Medical Center for other injuries including motor vehicle accidents, gunshot wounds, and assaults. The children's ages averaged 13 years, and almost half of them had been breast-fed.

The investigators, including Katherine K. Bedard and Dr. Glenn N. Saxe of the department of child and adolescent psychiatry at Boston University and their colleagues, assessed the children's degree of posttraumatic stress disorder (PTSD) by administering the Child PTSD Reaction Index (CPTSD-RI), and they asked the child's parents whether the child had been breast-fed.

The average CPTSD-RI score was 18 among those who had been breast-fed (corresponding to “mild” PTSD according to standard interpretations of this measure) and 25 among children who had not been breast-fed (corresponding to “moderate” PTSD).

The history of breast-feeding was not associated with the child's age, injury severity, socioeconomic status, symptoms of PTSD among the parents, or family strain.

The meeting was also sponsored by Boston University.

Poor Reading Linked to Psychopathy

Adolescents with poor reading skills are significantly more likely to exhibit psychiatric disorders than are adolescents who have adequate reading skills, reported David B. Goldston, Ph.D., of Duke University, Durham, N.C., and his associates.

Although the link between attention-deficit hyperactivity disorder and reading problems is well known, few studies have addressed whether non-ADHD psychiatric comorbidities in young people with reading problems are related to the ADHD or to the reading problems (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:25–32).

To determine associations between poor reading ability and psychiatric disorders in adolescence, Dr. Goldston and his colleagues reviewed psychiatric evaluations from 94 teens with poor reading skills and 94 teens with typical reading skills who were part of a larger longitudinal study.

After adjustment for sociodemographic variables, adolescents with reading problems were significantly more likely to have ADHD and significantly more likely to have anxiety disorders than were those with typical reading skills.

Overall, 14.4% of poor readers met criteria for affective disorders, compared with 7.9% of typical readers. Major depressive disorder (the most common affective disorder) was present in 12.9% of poor readers and 7.9% of typical readers.

In addition, 23.9% of poor readers met criteria for anxiety disorders, compared with 7.6% of typical readers. Social phobia (the most common anxiety disorder) was present in 15.2% of poor readers and 3.0% of typical readers.

Finally, 24.8% of the poor readers met criteria for disruptive behavior disorders, compared with 10.9% of the typical readers. ADHD (the most common disruptive behavior) was present in 18.0% of poor readers and 4.9% of typical readers, Dr. Goldston and his associates reported.

But after controlling for ADHD, they found that poor readers were still more than three times as likely as were typical readers to have anxiety disorders. In particular, poor readers were more than five times as likely to have generalized anxiety disorder and social phobia, compared with typical readers.

Poor reading ability also was significantly associated with higher overall levels of functional impairment, as well as impairment in the specific areas of role functioning, behavior toward others, thinking, and mood.

The findings suggest a relationship between psychiatric problems and reading problems in adolescence independent of ADHD and imply that reading assessments for adolescents who are having problems in school may not only improve their reading skills but also identify those in need of psychiatric care, the investigators said.

Gene CYP2D6 and Risperidone

The activity of the CYP2D6 gene may affect how children with developmental disorders respond to risperidone and release prolactin, based on data from a small study by Dr. Pieter W. Troost of the University of Groningen (the Netherlands) and colleagues.

Previous studies have shown that low to medium doses of risperidone in children may increase prolactin to dangerous levels that can be associated with side effects such as sexual dysfunction and impaired growth.

To assess the role of the CYP2D6 gene on risperidone metabolization and prolactin levels, the investigators reviewed data from 25 children aged 5–15 years with pervasive developmental disorders (J. Clin. Psychopharmacol. 2007;27:52–7).

Gene analysis showed that 5 children (20%) had no functional CYP2D6 genes, 6 (24%) had one functional gene, 12 (48%) had two functional genes, and 2 (8%) had three or more functional genes. The children were treated with an average daily risperidone dose of 0.06 mg/kg.

After 8 weeks of treatment, elevated serum prolactin levels appeared to be positively, but not significantly, correlated with a greater number of CYP2D6 genes. Elevated serum prolactin was, however, positively and significantly correlated with an increased dose of risperidone and an increased concentration of serum 9-hydroxyrisperidone. Children with more functional CYP2D6 genes had higher levels of the metabolite 9-hydroxyrisperidone.

Look for Borderline in Adolescents

Don't dismiss the possibility of comorbid borderline personality disorder in adolescents with severe psychiatric problems, wrote Dr. Andrew M. Chanen of the University of Melbourne, and his colleagues.

Borderline personality disorder (BPD) is diagnosed often in adults, but data in adolescents are limited, they said.

To define the psychiatric symptoms and functional abilities of adolescents with BPD, the researchers interviewed 177 psychiatric outpatients aged 15–18 years. The teens were divided into three groups: 46 patients with BPD, 88 patients with a personality disorder other than BPD, and 43 patients with no personality disorder. Adolescents in the BPD group met at least three of the DSM-IV criteria for BPD (J. Clin. Psychiatry 2007;68:297–306).

The BPD patients had significantly more and greater impairment compared with teens in the other two groups. BPD patients averaged more psychiatric diagnoses than did patients in either of the other two groups, and they were significantly more likely to have mood disorders, substance abuse/dependence, disruptive behavior disorders, and anxiety disorders than were the patients without personality disorders. In addition, teens with BPD were significantly more likely than were those in the other groups to have internalizing and externalizing problems (based on self-reports).

Breast-Feeding and PTSD

Among children who were hospitalized for severe burns or other injuries, those who were breast-fed during infancy experienced significantly fewer symptoms of posttraumatic stress disorder when queried 3 months after the injury, according to results of a poster presentation at the annual meeting of the International Society for Traumatic Stress Studies.

The study involved 29 children hospitalized at Shriners Burns Hospital, Boston, and 73 children hospitalized at Boston Medical Center for other injuries including motor vehicle accidents, gunshot wounds, and assaults. The children's ages averaged 13 years, and almost half of them had been breast-fed.

The investigators, including Katherine K. Bedard and Dr. Glenn N. Saxe of the department of child and adolescent psychiatry at Boston University and their colleagues, assessed the children's degree of posttraumatic stress disorder (PTSD) by administering the Child PTSD Reaction Index (CPTSD-RI), and they asked the child's parents whether the child had been breast-fed.

The average CPTSD-RI score was 18 among those who had been breast-fed (corresponding to “mild” PTSD according to standard interpretations of this measure) and 25 among children who had not been breast-fed (corresponding to “moderate” PTSD).

The history of breast-feeding was not associated with the child's age, injury severity, socioeconomic status, symptoms of PTSD among the parents, or family strain.

The meeting was also sponsored by Boston University.

Poor Reading Linked to Psychopathy

Adolescents with poor reading skills are significantly more likely to exhibit psychiatric disorders than are adolescents who have adequate reading skills, reported David B. Goldston, Ph.D., of Duke University, Durham, N.C., and his associates.

Although the link between attention-deficit hyperactivity disorder and reading problems is well known, few studies have addressed whether non-ADHD psychiatric comorbidities in young people with reading problems are related to the ADHD or to the reading problems (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:25–32).

To determine associations between poor reading ability and psychiatric disorders in adolescence, Dr. Goldston and his colleagues reviewed psychiatric evaluations from 94 teens with poor reading skills and 94 teens with typical reading skills who were part of a larger longitudinal study.

After adjustment for sociodemographic variables, adolescents with reading problems were significantly more likely to have ADHD and significantly more likely to have anxiety disorders than were those with typical reading skills.

Overall, 14.4% of poor readers met criteria for affective disorders, compared with 7.9% of typical readers. Major depressive disorder (the most common affective disorder) was present in 12.9% of poor readers and 7.9% of typical readers.

In addition, 23.9% of poor readers met criteria for anxiety disorders, compared with 7.6% of typical readers. Social phobia (the most common anxiety disorder) was present in 15.2% of poor readers and 3.0% of typical readers.

Finally, 24.8% of the poor readers met criteria for disruptive behavior disorders, compared with 10.9% of the typical readers. ADHD (the most common disruptive behavior) was present in 18.0% of poor readers and 4.9% of typical readers, Dr. Goldston and his associates reported.

But after controlling for ADHD, they found that poor readers were still more than three times as likely as were typical readers to have anxiety disorders. In particular, poor readers were more than five times as likely to have generalized anxiety disorder and social phobia, compared with typical readers.

Poor reading ability also was significantly associated with higher overall levels of functional impairment, as well as impairment in the specific areas of role functioning, behavior toward others, thinking, and mood.

The findings suggest a relationship between psychiatric problems and reading problems in adolescence independent of ADHD and imply that reading assessments for adolescents who are having problems in school may not only improve their reading skills but also identify those in need of psychiatric care, the investigators said.

Gene CYP2D6 and Risperidone

The activity of the CYP2D6 gene may affect how children with developmental disorders respond to risperidone and release prolactin, based on data from a small study by Dr. Pieter W. Troost of the University of Groningen (the Netherlands) and colleagues.

Previous studies have shown that low to medium doses of risperidone in children may increase prolactin to dangerous levels that can be associated with side effects such as sexual dysfunction and impaired growth.

To assess the role of the CYP2D6 gene on risperidone metabolization and prolactin levels, the investigators reviewed data from 25 children aged 5–15 years with pervasive developmental disorders (J. Clin. Psychopharmacol. 2007;27:52–7).

Gene analysis showed that 5 children (20%) had no functional CYP2D6 genes, 6 (24%) had one functional gene, 12 (48%) had two functional genes, and 2 (8%) had three or more functional genes. The children were treated with an average daily risperidone dose of 0.06 mg/kg.

After 8 weeks of treatment, elevated serum prolactin levels appeared to be positively, but not significantly, correlated with a greater number of CYP2D6 genes. Elevated serum prolactin was, however, positively and significantly correlated with an increased dose of risperidone and an increased concentration of serum 9-hydroxyrisperidone. Children with more functional CYP2D6 genes had higher levels of the metabolite 9-hydroxyrisperidone.

Look for Borderline in Adolescents

Don't dismiss the possibility of comorbid borderline personality disorder in adolescents with severe psychiatric problems, wrote Dr. Andrew M. Chanen of the University of Melbourne, and his colleagues.

Borderline personality disorder (BPD) is diagnosed often in adults, but data in adolescents are limited, they said.

To define the psychiatric symptoms and functional abilities of adolescents with BPD, the researchers interviewed 177 psychiatric outpatients aged 15–18 years. The teens were divided into three groups: 46 patients with BPD, 88 patients with a personality disorder other than BPD, and 43 patients with no personality disorder. Adolescents in the BPD group met at least three of the DSM-IV criteria for BPD (J. Clin. Psychiatry 2007;68:297–306).

The BPD patients had significantly more and greater impairment compared with teens in the other two groups. BPD patients averaged more psychiatric diagnoses than did patients in either of the other two groups, and they were significantly more likely to have mood disorders, substance abuse/dependence, disruptive behavior disorders, and anxiety disorders than were the patients without personality disorders. In addition, teens with BPD were significantly more likely than were those in the other groups to have internalizing and externalizing problems (based on self-reports).

Breast-Feeding and PTSD

Among children who were hospitalized for severe burns or other injuries, those who were breast-fed during infancy experienced significantly fewer symptoms of posttraumatic stress disorder when queried 3 months after the injury, according to results of a poster presentation at the annual meeting of the International Society for Traumatic Stress Studies.

The study involved 29 children hospitalized at Shriners Burns Hospital, Boston, and 73 children hospitalized at Boston Medical Center for other injuries including motor vehicle accidents, gunshot wounds, and assaults. The children's ages averaged 13 years, and almost half of them had been breast-fed.

The investigators, including Katherine K. Bedard and Dr. Glenn N. Saxe of the department of child and adolescent psychiatry at Boston University and their colleagues, assessed the children's degree of posttraumatic stress disorder (PTSD) by administering the Child PTSD Reaction Index (CPTSD-RI), and they asked the child's parents whether the child had been breast-fed.

The average CPTSD-RI score was 18 among those who had been breast-fed (corresponding to “mild” PTSD according to standard interpretations of this measure) and 25 among children who had not been breast-fed (corresponding to “moderate” PTSD).

The history of breast-feeding was not associated with the child's age, injury severity, socioeconomic status, symptoms of PTSD among the parents, or family strain.

The meeting was also sponsored by Boston University.

Poor Reading Linked to Psychopathy

Adolescents with poor reading skills are significantly more likely to exhibit psychiatric disorders than are adolescents who have adequate reading skills, reported David B. Goldston, Ph.D., of Duke University, Durham, N.C., and his associates.

Although the link between attention-deficit hyperactivity disorder and reading problems is well known, few studies have addressed whether non-ADHD psychiatric comorbidities in young people with reading problems are related to the ADHD or to the reading problems (J. Am. Acad. Child Adolesc. Psychiatry 2007;46:25–32).

To determine associations between poor reading ability and psychiatric disorders in adolescence, Dr. Goldston and his colleagues reviewed psychiatric evaluations from 94 teens with poor reading skills and 94 teens with typical reading skills who were part of a larger longitudinal study.

After adjustment for sociodemographic variables, adolescents with reading problems were significantly more likely to have ADHD and significantly more likely to have anxiety disorders than were those with typical reading skills.

Overall, 14.4% of poor readers met criteria for affective disorders, compared with 7.9% of typical readers. Major depressive disorder (the most common affective disorder) was present in 12.9% of poor readers and 7.9% of typical readers.

In addition, 23.9% of poor readers met criteria for anxiety disorders, compared with 7.6% of typical readers. Social phobia (the most common anxiety disorder) was present in 15.2% of poor readers and 3.0% of typical readers.

Finally, 24.8% of the poor readers met criteria for disruptive behavior disorders, compared with 10.9% of the typical readers. ADHD (the most common disruptive behavior) was present in 18.0% of poor readers and 4.9% of typical readers, Dr. Goldston and his associates reported.

But after controlling for ADHD, they found that poor readers were still more than three times as likely as were typical readers to have anxiety disorders. In particular, poor readers were more than five times as likely to have generalized anxiety disorder and social phobia, compared with typical readers.

Poor reading ability also was significantly associated with higher overall levels of functional impairment, as well as impairment in the specific areas of role functioning, behavior toward others, thinking, and mood.

The findings suggest a relationship between psychiatric problems and reading problems in adolescence independent of ADHD and imply that reading assessments for adolescents who are having problems in school may not only improve their reading skills but also identify those in need of psychiatric care, the investigators said.

Gene CYP2D6 and Risperidone

The activity of the CYP2D6 gene may affect how children with developmental disorders respond to risperidone and release prolactin, based on data from a small study by Dr. Pieter W. Troost of the University of Groningen (the Netherlands) and colleagues.

Previous studies have shown that low to medium doses of risperidone in children may increase prolactin to dangerous levels that can be associated with side effects such as sexual dysfunction and impaired growth.

To assess the role of the CYP2D6 gene on risperidone metabolization and prolactin levels, the investigators reviewed data from 25 children aged 5–15 years with pervasive developmental disorders (J. Clin. Psychopharmacol. 2007;27:52–7).

Gene analysis showed that 5 children (20%) had no functional CYP2D6 genes, 6 (24%) had one functional gene, 12 (48%) had two functional genes, and 2 (8%) had three or more functional genes. The children were treated with an average daily risperidone dose of 0.06 mg/kg.

After 8 weeks of treatment, elevated serum prolactin levels appeared to be positively, but not significantly, correlated with a greater number of CYP2D6 genes. Elevated serum prolactin was, however, positively and significantly correlated with an increased dose of risperidone and an increased concentration of serum 9-hydroxyrisperidone. Children with more functional CYP2D6 genes had higher levels of the metabolite 9-hydroxyrisperidone.

Demographics Affect Immunization

Single motherhood is a significant predictor in delaying the completion of the 4:3:1:3 immunization series, according to a study published in the American Journal of Public Health. Only about 17% of children whose mothers had never been married had up-to-date immunizations, compared to about 75% of children whose mothers were married. The researchers used data from the 2003 National Immunization Survey, a nationwide household survey about vaccination, and verified the responses through a survey of health care providers. The study included a sample of 11,860 children aged 19–35 months. But the researchers also found some surprises in their analysis. For example, after researchers controlled for other factors, they found that immunization completion rates were higher among children of mothers with less than 12 years of education, compared with children whose mothers had college degrees.

Disparities Seen in Children's Health

Black children are most likely to experience unhealthy conditions, according to an analysis of how children fare in 100 metropolitan areas with the largest populations of children. The research, which was conducted by the Harvard School of Public Health and the Center for the Advancement of Health, was supported by the W.K. Kellogg Foundation. The report showed that in 90% of metropolitan areas, the rate of low-birth-weight babies born to black mothers was more than 9%, compared with a target rate of 5% set by Healthy People 2010. In 60% of the areas evaluated, the preterm birth rate for black mothers was more than 15%. The report also evaluated segregation by neighborhoods and schools, poverty, and home ownership. The report is available online at

diversitydata.org

Citizenship Proof Slows Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin.

Birth Defects Tab: $2.6 Billion

Birth defects accounted for 139,100 hospital admissions and $2.6 billion in treatment costs in 2004, according to a report compiled by the Agency for Healthcare Research and Quality. Heart anomalies, such as atrial and ventricular septal defects, were the deadliest and accounted for the highest number of admissions—one-third—and the highest costs, $1.4 billion. The second-most common cause of admission was for digestive conditions such as pyloric stenosis. According to the report, between 1997 and 2004, the rate of admission increased by more than 25% for these two leading categories of birth defects, when they were listed as either the principal or coexisting condition. Genitourinary defects and nervous system anomalies accounted for the third- and fourth-leading causes of admissions, followed by other problems such as cleft palate, hip deformity, skull and facial bone defects, and spinal and foot deformities. The report can be found at

www.hcup-us.ahrq.gov/reports/statbriefs/sb24.pdf

Census: Children Slightly Better Off

A new Census Bureau report finds that American children were slightly better off in 2003 than they were in 1994. The report, “A Child's Day: 2003,” is the Census Bureau's third look at children's well-being and daily activities. It was based on interviews with about 10,000 parents and was extrapolated to draw conclusions on the status of 73 million children. In 2003, about 51 million children were living in two-parent households; 18% or 12.8 million lived in families with incomes below the federal poverty line. Among some changes: Parents were more likely to restrict TV viewing than in 1994. Seventy-five percent of children aged 12–17 were on track academically in 2003, compared to 69% in 1994. The report also shows that teenagers are less likely to eat with, or receive praise from, parents. Full details are available at

www.census.gov/prod/2007pubs/p70-109.pdf

Demographics Affect Immunization

Single motherhood is a significant predictor in delaying the completion of the 4:3:1:3 immunization series, according to a study published in the American Journal of Public Health. Only about 17% of children whose mothers had never been married had up-to-date immunizations, compared to about 75% of children whose mothers were married. The researchers used data from the 2003 National Immunization Survey, a nationwide household survey about vaccination, and verified the responses through a survey of health care providers. The study included a sample of 11,860 children aged 19–35 months. But the researchers also found some surprises in their analysis. For example, after researchers controlled for other factors, they found that immunization completion rates were higher among children of mothers with less than 12 years of education, compared with children whose mothers had college degrees.

Disparities Seen in Children's Health

Black children are most likely to experience unhealthy conditions, according to an analysis of how children fare in 100 metropolitan areas with the largest populations of children. The research, which was conducted by the Harvard School of Public Health and the Center for the Advancement of Health, was supported by the W.K. Kellogg Foundation. The report showed that in 90% of metropolitan areas, the rate of low-birth-weight babies born to black mothers was more than 9%, compared with a target rate of 5% set by Healthy People 2010. In 60% of the areas evaluated, the preterm birth rate for black mothers was more than 15%. The report also evaluated segregation by neighborhoods and schools, poverty, and home ownership. The report is available online at

diversitydata.org

Citizenship Proof Slows Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin.

Birth Defects Tab: $2.6 Billion

Birth defects accounted for 139,100 hospital admissions and $2.6 billion in treatment costs in 2004, according to a report compiled by the Agency for Healthcare Research and Quality. Heart anomalies, such as atrial and ventricular septal defects, were the deadliest and accounted for the highest number of admissions—one-third—and the highest costs, $1.4 billion. The second-most common cause of admission was for digestive conditions such as pyloric stenosis. According to the report, between 1997 and 2004, the rate of admission increased by more than 25% for these two leading categories of birth defects, when they were listed as either the principal or coexisting condition. Genitourinary defects and nervous system anomalies accounted for the third- and fourth-leading causes of admissions, followed by other problems such as cleft palate, hip deformity, skull and facial bone defects, and spinal and foot deformities. The report can be found at

www.hcup-us.ahrq.gov/reports/statbriefs/sb24.pdf

Census: Children Slightly Better Off

A new Census Bureau report finds that American children were slightly better off in 2003 than they were in 1994. The report, “A Child's Day: 2003,” is the Census Bureau's third look at children's well-being and daily activities. It was based on interviews with about 10,000 parents and was extrapolated to draw conclusions on the status of 73 million children. In 2003, about 51 million children were living in two-parent households; 18% or 12.8 million lived in families with incomes below the federal poverty line. Among some changes: Parents were more likely to restrict TV viewing than in 1994. Seventy-five percent of children aged 12–17 were on track academically in 2003, compared to 69% in 1994. The report also shows that teenagers are less likely to eat with, or receive praise from, parents. Full details are available at

www.census.gov/prod/2007pubs/p70-109.pdf

Demographics Affect Immunization

Single motherhood is a significant predictor in delaying the completion of the 4:3:1:3 immunization series, according to a study published in the American Journal of Public Health. Only about 17% of children whose mothers had never been married had up-to-date immunizations, compared to about 75% of children whose mothers were married. The researchers used data from the 2003 National Immunization Survey, a nationwide household survey about vaccination, and verified the responses through a survey of health care providers. The study included a sample of 11,860 children aged 19–35 months. But the researchers also found some surprises in their analysis. For example, after researchers controlled for other factors, they found that immunization completion rates were higher among children of mothers with less than 12 years of education, compared with children whose mothers had college degrees.

Disparities Seen in Children's Health

Black children are most likely to experience unhealthy conditions, according to an analysis of how children fare in 100 metropolitan areas with the largest populations of children. The research, which was conducted by the Harvard School of Public Health and the Center for the Advancement of Health, was supported by the W.K. Kellogg Foundation. The report showed that in 90% of metropolitan areas, the rate of low-birth-weight babies born to black mothers was more than 9%, compared with a target rate of 5% set by Healthy People 2010. In 60% of the areas evaluated, the preterm birth rate for black mothers was more than 15%. The report also evaluated segregation by neighborhoods and schools, poverty, and home ownership. The report is available online at

diversitydata.org

Citizenship Proof Slows Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin.

Birth Defects Tab: $2.6 Billion

Birth defects accounted for 139,100 hospital admissions and $2.6 billion in treatment costs in 2004, according to a report compiled by the Agency for Healthcare Research and Quality. Heart anomalies, such as atrial and ventricular septal defects, were the deadliest and accounted for the highest number of admissions—one-third—and the highest costs, $1.4 billion. The second-most common cause of admission was for digestive conditions such as pyloric stenosis. According to the report, between 1997 and 2004, the rate of admission increased by more than 25% for these two leading categories of birth defects, when they were listed as either the principal or coexisting condition. Genitourinary defects and nervous system anomalies accounted for the third- and fourth-leading causes of admissions, followed by other problems such as cleft palate, hip deformity, skull and facial bone defects, and spinal and foot deformities. The report can be found at

www.hcup-us.ahrq.gov/reports/statbriefs/sb24.pdf

Census: Children Slightly Better Off

A new Census Bureau report finds that American children were slightly better off in 2003 than they were in 1994. The report, “A Child's Day: 2003,” is the Census Bureau's third look at children's well-being and daily activities. It was based on interviews with about 10,000 parents and was extrapolated to draw conclusions on the status of 73 million children. In 2003, about 51 million children were living in two-parent households; 18% or 12.8 million lived in families with incomes below the federal poverty line. Among some changes: Parents were more likely to restrict TV viewing than in 1994. Seventy-five percent of children aged 12–17 were on track academically in 2003, compared to 69% in 1994. The report also shows that teenagers are less likely to eat with, or receive praise from, parents. Full details are available at

www.census.gov/prod/2007pubs/p70-109.pdf

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.) along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. While two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (DMd.)— it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as currently written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Unique New Drugs on Decline

The Food and Drug Administration only approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (DCalif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research anddevelopment spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen, which put its conclusions in a letter published in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

2007 Advocacy Agenda

Finding a permanent solution to the way Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians this year. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect but that was only a stopgap, according to the AMA. “This year we will work with Congress, the Administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push for an expansion of health insurance coverage for the uninsured this year. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies. Another item at the top of the agenda at the AAFP is encouraging the use of new types of payment systems that reward continuity of care, such as paying primary care physicians a care management fee. “The current system just doesn't really reward that,” Dr. Rick Kellerman, AAFP president, said in an interview. Other AAFP priorities include increasing federal support for health information technology adoption and expanding medical education.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results—Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.) along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. While two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (DMd.)— it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as currently written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Unique New Drugs on Decline

The Food and Drug Administration only approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (DCalif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research anddevelopment spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen, which put its conclusions in a letter published in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

2007 Advocacy Agenda

Finding a permanent solution to the way Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians this year. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect but that was only a stopgap, according to the AMA. “This year we will work with Congress, the Administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push for an expansion of health insurance coverage for the uninsured this year. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies. Another item at the top of the agenda at the AAFP is encouraging the use of new types of payment systems that reward continuity of care, such as paying primary care physicians a care management fee. “The current system just doesn't really reward that,” Dr. Rick Kellerman, AAFP president, said in an interview. Other AAFP priorities include increasing federal support for health information technology adoption and expanding medical education.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results—Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.) along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. While two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (DMd.)— it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as currently written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Unique New Drugs on Decline

The Food and Drug Administration only approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (DCalif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research anddevelopment spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen, which put its conclusions in a letter published in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

2007 Advocacy Agenda

Finding a permanent solution to the way Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians this year. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect but that was only a stopgap, according to the AMA. “This year we will work with Congress, the Administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push for an expansion of health insurance coverage for the uninsured this year. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies. Another item at the top of the agenda at the AAFP is encouraging the use of new types of payment systems that reward continuity of care, such as paying primary care physicians a care management fee. “The current system just doesn't really reward that,” Dr. Rick Kellerman, AAFP president, said in an interview. Other AAFP priorities include increasing federal support for health information technology adoption and expanding medical education.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results—Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Alendronate Benefits Linger

Postmenopausal women who discontinue alendronate after 5 years of treatment may experience a moderate decline in bone mineral density but are not at a significantly higher risk for fracture compared with those who continue alendronate for an additional 5 years, reported Dennis M. Black, Ph.D., of the University of California, San Francisco, and his colleagues.

But women at high risk of clinical vertebral fractures may benefit by continuing beyond 5 years, they wrote (JAMA 2006; 296:2927–38).

The FIT Long-Term Extension (FLEX) study was open to women who had been assigned to the alendronate treatment arm in the Fracture Intervention Trial (FIT) and who had completed at least 3 years of alendronate treatment. Patients were randomly assigned to receive daily treatment with 10 mg alendronate (30%), 5 mg alendronate (30%), or placebo (40%). Of 1,099 women participating in FLEX, 437 were assigned to placebo, 329 were assigned to 5 mg alendronate, and 333 were assigned to 10 mg alendronate.

After 5 years, total hip bone mineral density declined 3.38% from baseline values in the placebo group and 1.02% in the combination of the two alendronate groups.

The combined alendronate group experienced a mean 5.26% increase from FLEX baseline in lumbar spine BMD, compared with a mean 1.52% increase in the placebo group.

The two alendronate groups did not differ significantly in their incidence of total clinical fractures or nonvertebral fractures. However, the risk of clinical vertebral fractures was significantly higher in the placebo group (5.3%) than in the combined alendronate group (2.4%).

Foot Ulcers Court Comorbidity

Many diabetic patients with foot ulcers have peripheral arterial disease, infection, and disabling comorbidities, according to a large European study.

Of 1,229 consecutive patients presenting with new foot ulcers at 14 hospitals in 10 European countries, only 24% had neither peripheral arterial disease (PAD) nor infection, reported Dr. Leonne Prompers of University Hospital Maastricht, the Netherlands, and colleagues (Diabetologia 2007;50:18–25). Twenty-seven percent of the patients had infection alone, 18% had PAD alone, and 31% had both PAD and infection.

In addition, 32% had one or more disabling comorbidities, including 15% with severe visual impairment, 6% with end-stage renal disease, and 11% with heart failure or severe angina pectoris. Ten percent were unable to stand or walk without help.

The European Study Group on Diabetes and the Lower Extremity (Eurodiale) enrolled the patients between September 2003 and October 2004 and followed them for 1 year. This report tabulates the patients' baseline data; follow-up data will be published at a later date.

“[The data] contain an important message: many patients with diabetic foot ulcers are severely ill, and this is reflected by the severe underlying pathology and the presence of disabling comorbidity,” the authors wrote.

HbA_1c Levels Predict Sepsis Outcomes

Hemoglobin A_1c levels at hospital admission are predictive for hospital mortality and length of stay in diabetic patients with sepsis, reported Dr. Ivan Gornik of Rebro University Hospital in Zagreb, Croatia, and associates.

The investigators conducted a prospective, observational study of adults with type 2 diabetes admitted to a medical ward or medical intensive care unit because of sepsis. APACHE II and sequential organ failure assessment (SOFA) scores, plasma glucose levels, C-reactive protein (CRP), and leukocyte counts were determined upon hospital admission. HbA_1c levels were determined the following day.

The study was conducted from November 2003 to December 2005 and enrolled 286 adults, of which 121 (42%) were female. A total of 224 patients survived, with a median length of stay of 9 days (range 7–13). Of the 62 patients (22%) who died in the hospital, 32 (52%) were female, according to the study.

Survivors were significantly younger than nonsurvivors were and had better APACHE II and SOFA scores. Median ages of survivors and nonsurvivors were 61 years (range 38–72) and 66 years (range 48–76), respectively (Diab. Res. Clin. Pract. 2006 [Epub doi:10.1016/j.diabres.2006. 10.017]).

Survivors had significantly lower HbA_1c values (median 8.2) than did nonsurvivors (median 9.8). In multivariate logistic regression analysis, HbA_1c level was an independent predictor of hospital mortality, with an adjusted odds ratio of 1.36 for each increase of 1%. In the same analysis, female gender, APACHE II score, and SOFA score were also independent predictors of hospital mortality, whereas age, plasma glucose levels at admission, and CRP were not.

Alendronate Benefits Linger

Postmenopausal women who discontinue alendronate after 5 years of treatment may experience a moderate decline in bone mineral density but are not at a significantly higher risk for fracture compared with those who continue alendronate for an additional 5 years, reported Dennis M. Black, Ph.D., of the University of California, San Francisco, and his colleagues.

But women at high risk of clinical vertebral fractures may benefit by continuing beyond 5 years, they wrote (JAMA 2006; 296:2927–38).

The FIT Long-Term Extension (FLEX) study was open to women who had been assigned to the alendronate treatment arm in the Fracture Intervention Trial (FIT) and who had completed at least 3 years of alendronate treatment. Patients were randomly assigned to receive daily treatment with 10 mg alendronate (30%), 5 mg alendronate (30%), or placebo (40%). Of 1,099 women participating in FLEX, 437 were assigned to placebo, 329 were assigned to 5 mg alendronate, and 333 were assigned to 10 mg alendronate.

After 5 years, total hip bone mineral density declined 3.38% from baseline values in the placebo group and 1.02% in the combination of the two alendronate groups.

The combined alendronate group experienced a mean 5.26% increase from FLEX baseline in lumbar spine BMD, compared with a mean 1.52% increase in the placebo group.

The two alendronate groups did not differ significantly in their incidence of total clinical fractures or nonvertebral fractures. However, the risk of clinical vertebral fractures was significantly higher in the placebo group (5.3%) than in the combined alendronate group (2.4%).

Foot Ulcers Court Comorbidity

Many diabetic patients with foot ulcers have peripheral arterial disease, infection, and disabling comorbidities, according to a large European study.

Of 1,229 consecutive patients presenting with new foot ulcers at 14 hospitals in 10 European countries, only 24% had neither peripheral arterial disease (PAD) nor infection, reported Dr. Leonne Prompers of University Hospital Maastricht, the Netherlands, and colleagues (Diabetologia 2007;50:18–25). Twenty-seven percent of the patients had infection alone, 18% had PAD alone, and 31% had both PAD and infection.

In addition, 32% had one or more disabling comorbidities, including 15% with severe visual impairment, 6% with end-stage renal disease, and 11% with heart failure or severe angina pectoris. Ten percent were unable to stand or walk without help.

The European Study Group on Diabetes and the Lower Extremity (Eurodiale) enrolled the patients between September 2003 and October 2004 and followed them for 1 year. This report tabulates the patients' baseline data; follow-up data will be published at a later date.

“[The data] contain an important message: many patients with diabetic foot ulcers are severely ill, and this is reflected by the severe underlying pathology and the presence of disabling comorbidity,” the authors wrote.

HbA_1c Levels Predict Sepsis Outcomes

Hemoglobin A_1c levels at hospital admission are predictive for hospital mortality and length of stay in diabetic patients with sepsis, reported Dr. Ivan Gornik of Rebro University Hospital in Zagreb, Croatia, and associates.

The investigators conducted a prospective, observational study of adults with type 2 diabetes admitted to a medical ward or medical intensive care unit because of sepsis. APACHE II and sequential organ failure assessment (SOFA) scores, plasma glucose levels, C-reactive protein (CRP), and leukocyte counts were determined upon hospital admission. HbA_1c levels were determined the following day.

The study was conducted from November 2003 to December 2005 and enrolled 286 adults, of which 121 (42%) were female. A total of 224 patients survived, with a median length of stay of 9 days (range 7–13). Of the 62 patients (22%) who died in the hospital, 32 (52%) were female, according to the study.

Survivors were significantly younger than nonsurvivors were and had better APACHE II and SOFA scores. Median ages of survivors and nonsurvivors were 61 years (range 38–72) and 66 years (range 48–76), respectively (Diab. Res. Clin. Pract. 2006 [Epub doi:10.1016/j.diabres.2006. 10.017]).

Survivors had significantly lower HbA_1c values (median 8.2) than did nonsurvivors (median 9.8). In multivariate logistic regression analysis, HbA_1c level was an independent predictor of hospital mortality, with an adjusted odds ratio of 1.36 for each increase of 1%. In the same analysis, female gender, APACHE II score, and SOFA score were also independent predictors of hospital mortality, whereas age, plasma glucose levels at admission, and CRP were not.

Alendronate Benefits Linger

Postmenopausal women who discontinue alendronate after 5 years of treatment may experience a moderate decline in bone mineral density but are not at a significantly higher risk for fracture compared with those who continue alendronate for an additional 5 years, reported Dennis M. Black, Ph.D., of the University of California, San Francisco, and his colleagues.

But women at high risk of clinical vertebral fractures may benefit by continuing beyond 5 years, they wrote (JAMA 2006; 296:2927–38).

The FIT Long-Term Extension (FLEX) study was open to women who had been assigned to the alendronate treatment arm in the Fracture Intervention Trial (FIT) and who had completed at least 3 years of alendronate treatment. Patients were randomly assigned to receive daily treatment with 10 mg alendronate (30%), 5 mg alendronate (30%), or placebo (40%). Of 1,099 women participating in FLEX, 437 were assigned to placebo, 329 were assigned to 5 mg alendronate, and 333 were assigned to 10 mg alendronate.

After 5 years, total hip bone mineral density declined 3.38% from baseline values in the placebo group and 1.02% in the combination of the two alendronate groups.

The combined alendronate group experienced a mean 5.26% increase from FLEX baseline in lumbar spine BMD, compared with a mean 1.52% increase in the placebo group.

The two alendronate groups did not differ significantly in their incidence of total clinical fractures or nonvertebral fractures. However, the risk of clinical vertebral fractures was significantly higher in the placebo group (5.3%) than in the combined alendronate group (2.4%).

Foot Ulcers Court Comorbidity

Many diabetic patients with foot ulcers have peripheral arterial disease, infection, and disabling comorbidities, according to a large European study.

Of 1,229 consecutive patients presenting with new foot ulcers at 14 hospitals in 10 European countries, only 24% had neither peripheral arterial disease (PAD) nor infection, reported Dr. Leonne Prompers of University Hospital Maastricht, the Netherlands, and colleagues (Diabetologia 2007;50:18–25). Twenty-seven percent of the patients had infection alone, 18% had PAD alone, and 31% had both PAD and infection.

In addition, 32% had one or more disabling comorbidities, including 15% with severe visual impairment, 6% with end-stage renal disease, and 11% with heart failure or severe angina pectoris. Ten percent were unable to stand or walk without help.

The European Study Group on Diabetes and the Lower Extremity (Eurodiale) enrolled the patients between September 2003 and October 2004 and followed them for 1 year. This report tabulates the patients' baseline data; follow-up data will be published at a later date.

“[The data] contain an important message: many patients with diabetic foot ulcers are severely ill, and this is reflected by the severe underlying pathology and the presence of disabling comorbidity,” the authors wrote.

HbA_1c Levels Predict Sepsis Outcomes

Hemoglobin A_1c levels at hospital admission are predictive for hospital mortality and length of stay in diabetic patients with sepsis, reported Dr. Ivan Gornik of Rebro University Hospital in Zagreb, Croatia, and associates.

The investigators conducted a prospective, observational study of adults with type 2 diabetes admitted to a medical ward or medical intensive care unit because of sepsis. APACHE II and sequential organ failure assessment (SOFA) scores, plasma glucose levels, C-reactive protein (CRP), and leukocyte counts were determined upon hospital admission. HbA_1c levels were determined the following day.

The study was conducted from November 2003 to December 2005 and enrolled 286 adults, of which 121 (42%) were female. A total of 224 patients survived, with a median length of stay of 9 days (range 7–13). Of the 62 patients (22%) who died in the hospital, 32 (52%) were female, according to the study.

Survivors were significantly younger than nonsurvivors were and had better APACHE II and SOFA scores. Median ages of survivors and nonsurvivors were 61 years (range 38–72) and 66 years (range 48–76), respectively (Diab. Res. Clin. Pract. 2006 [Epub doi:10.1016/j.diabres.2006. 10.017]).

Survivors had significantly lower HbA_1c values (median 8.2) than did nonsurvivors (median 9.8). In multivariate logistic regression analysis, HbA_1c level was an independent predictor of hospital mortality, with an adjusted odds ratio of 1.36 for each increase of 1%. In the same analysis, female gender, APACHE II score, and SOFA score were also independent predictors of hospital mortality, whereas age, plasma glucose levels at admission, and CRP were not.

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.

2007 Advocacy Agenda

Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.

Unique New Drugs on Decline

The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

New Osteoporosis Health Claims

FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.

2007 Advocacy Agenda

Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.

Unique New Drugs on Decline

The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

New Osteoporosis Health Claims

FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.

2007 Advocacy Agenda

Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.

Unique New Drugs on Decline

The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.

FDA Panels Held Less Often

An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

New Osteoporosis Health Claims

FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, said the GAO in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared to 15–25 previously. Though drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, said the GAO. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving; by July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, said the GAO in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared to 15–25 previously. Though drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, said the GAO. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving; by July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, said the GAO in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared to 15–25 previously. Though drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, said the GAO. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving; by July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to prescribe investigational drugs. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency would make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, the GAO said in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared with 15–25 previously. Although drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, the GAO said. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving. By July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to prescribe investigational drugs. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency would make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, the GAO said in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared with 15–25 previously. Although drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, the GAO said. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving. By July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to prescribe investigational drugs. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published on Dec. 14, said the agency would make it easier for physicians to access experimental therapies, and for manufacturers to make them available. “FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients,” Dr. Janet Woodcock, FDA deputy commissioner for operations, said in a statement. A separate proposed rule would make it easier for manufacturers to recover costs. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University, Richmond. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll.

Lax Enforcement of Ad Regulations

FDA issued fewer violation letters regarding direct-to-consumer drug advertising during 2002–2005 than it did in previous years, the Government Accountability Office reported. Further, FDA took longer to send such letters to drug manufacturers, said the watchdog agency, pointing out that the industry spent $4.2 billion in 2005 on DTC advertising. Such advertisements can be positive—by encouraging consumers to talk to physicians—but can also increase spending on the advertised drug and other drugs to treat the same condition, the GAO said in its December report. GAO said that it took 4 months for the agency to draft, review, approve, and issue a letter in 2002–2005, compared with 2 weeks during 1997–2001, and that it issued 8–11 letters a year, compared with 15–25 previously. Although drug companies often complied with orders to cease and desist, sometimes the manufacturers would later put out similar violative materials for the same drugs, the GAO said. The GAO said it had noted in a previous report in 2002 that the FDA's violation letter process was being delayed by internal reviews. That has not improved, according to December's report, which recommended that FDA set criteria for prioritizing advertisements for review, systematically apply the criteria, and track materials reviewed.

NYC Bans Trans Fat

In a move aimed at improving the healthfulness of restaurant food, the New York City Board of Health recently voted to require that all of the city's restaurants remove artificial trans fats from foods by July 2008. The mandate gives restaurants until July 1, 2007, to switch to oils, margarines, and shortenings that have less than 0.5 grams of trans fat per serving. By July 1, 2008, all other food items sold in restaurants must meet the same mark. New York is the first city to make such a move. The move was praised by the American Diabetes Association: “When you consider that many American adults—and their children—are eating out several times a week, it is even more difficult to avoid trans fats and maintain a healthy diet,” said Dr. Peter Sheehan, president of the American Diabetes Association's New York City Leadership Council. “For more than 700,000 New York City adults diagnosed with diabetes, the passage of this proposal eliminates a major source of artificial trans fats and should serve as a model for other cities to consider.” In testimony in 2006 before the New York City Board of Health, the New York State Restaurant Association said that although the measure is well intentioned, it will not achieve the health benefits being sought. The 18-month transition does not give restaurateurs enough time to find healthful alternatives, the group said. Many will end up returning to the use of oils high in saturated fats.

Changes to HSA Rules

Legislation signed into law in December eases the use of health savings accounts. Previously, HSA participants could contribute only the amount they were required to pay out of pocket before their high-deductible health insurance policies kicked in. Under the new law, participants can contribute up to $2,700 for individual accounts and $5,450 for family accounts. The measure also allows employers to contribute more to the HSA accounts of non-highly compensated workers, and allows a one-time, tax-free rollover of individual retirement account funds into an HSA. “These provisions will help many Americans find more affordable and tax-preferred ways to pay for health care costs,” said James A. Klein, president of the American Benefits Council, an organization of large employers and health plan administrators.

Mistaken Menactra Still Protective

Persons who mistakenly received the meningococcal conjugate vaccine (Menactra) subcutaneously rather than intramuscularly were nonetheless sufficiently protected, according to a report by the Centers for Disease Control and Prevention.

The CDC received reports that 101 persons aged 11–47 years (median age 17.5) in seven states received the new meningococcal vaccine (MCV4) subcutaneously, although it is licensed for intramuscular use only. Of the 38 individuals who agreed to participate in a study, 36 were protected for each of the four vaccine subgroups (A, C, Y, and W-135). Two patients failed to achieve protective titers against a single serogroup (serogroup C in one case and serogroup W-135 in the other).

The geometric mean titers (GMTs) were significantly lower for the subcutaneous vaccinees, compared with age-matched intramuscular vaccinees from the MCV4 clinical trials, for serogroups A, C, and Y, but there were no significant differences in GMTs for serogroup W-135 (MMWR 2006;55:1016–7).

Based on these findings, the researchers did not recommend revaccination for any of the subcutaneous vaccinees.

The meningococcal polysaccharide vaccine, which has been used for 30 years, is licensed for subcutaneous use, not intramuscular use, and this is the most likely reason for the misadministration of MCV4, according to the health care providers involved in the study.

Flu Vaccine Less Effective in SLE

Influenza vaccination appears to be safe in patients with quiescent systemic lupus erythematosus, but may be less effective than in healthy controls, reported Dr. A. Holvast of the University of Groningen, the Netherlands, and colleagues.

They studied 56 SLE patients with quiescent disease who were divided into groups based on their use of immunosuppressive drugs, with 12 using no drugs, 17 using hydroxychloroquine (at least 400 mg/day), 13 using azathioprine (at least 50 mg/day), and 14 using prednisone (at least 10 mg/day) (Ann. Rheum. Dis. 2006; 65:913–8).

All patients, along with 18 healthy controls, were vaccinated in October and November of 2003 with Influvac (Solvay Pharmaceuticals Inc.), a trivalent influenza vaccine. At 30 days after vaccination, the SLE disease activity index had not changed in any of the patient groups, and there were no significant changes in patient-recorded visual analogue scores—suggesting that vaccination did not induce disease activity.

Compared with controls, SLE patients had more systemic side effects of vaccination, although these were all mild. After excluding all subjects who had been vaccinated the previous year, the researchers found that significantly fewer SLE patients achieved seroconversions and protective titers to A/H1N1 and A/H3N2.

“It is conceivable that SLE patients have an intrinsic [immunologic] defect that results in decreased responsiveness to vaccination,” the authors wrote, adding that the use of immunosuppressive drugs may further decrease the vaccination response in these patients. There was a trend toward a further decrease in the vaccine's efficacy among systemic lupus erythematosus (SLE) patients taking azathioprine, compared with several other immunosuppressive drugs.

Vaccine Refusal Tied to Measles Cases

The vast majority of the people infected last year in the largest documented measles outbreak to hit the United States in a decade were children whose parents had objected to immunization.

The Indiana outbreak, which involved 34 people, “shows that states, localities, and health care organizations need to implement more effective policies to protect persons traveling abroad, home-schooled children, and health care workers against measles and other vaccine-preventable diseases,” wrote Amy A. Parker of the Centers for Disease Control and Prevention in Atlanta, and her associates.

Of the 34 infections, 32 were in people who had never been vaccinated for measles; 30 of the patients (88%) were children aged 19 years or younger.

“Concern about adverse events, particularly related to media reports of a putative association between vaccinations and autism and of the dangers of thimerosal, appeared to play a major role in the decision of these families to decline vaccination,” the investigators found (N. Engl. J. Med. 2006;355:447–55).

“As long as some groups within a given community respond to spurious claims about the risks of the vaccine by refusing to vaccinate their infants, further outbreaks will occur,” said Dr. E. Kim Mulholland, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, in a commentary that ran with the article (N. Engl. J. Med. 2006;355:440–3).

Mistaken Menactra Still Protective

Persons who mistakenly received the meningococcal conjugate vaccine (Menactra) subcutaneously rather than intramuscularly were nonetheless sufficiently protected, according to a report by the Centers for Disease Control and Prevention.

The CDC received reports that 101 persons aged 11–47 years (median age 17.5) in seven states received the new meningococcal vaccine (MCV4) subcutaneously, although it is licensed for intramuscular use only. Of the 38 individuals who agreed to participate in a study, 36 were protected for each of the four vaccine subgroups (A, C, Y, and W-135). Two patients failed to achieve protective titers against a single serogroup (serogroup C in one case and serogroup W-135 in the other).

The geometric mean titers (GMTs) were significantly lower for the subcutaneous vaccinees, compared with age-matched intramuscular vaccinees from the MCV4 clinical trials, for serogroups A, C, and Y, but there were no significant differences in GMTs for serogroup W-135 (MMWR 2006;55:1016–7).

Based on these findings, the researchers did not recommend revaccination for any of the subcutaneous vaccinees.

The meningococcal polysaccharide vaccine, which has been used for 30 years, is licensed for subcutaneous use, not intramuscular use, and this is the most likely reason for the misadministration of MCV4, according to the health care providers involved in the study.

Flu Vaccine Less Effective in SLE

Influenza vaccination appears to be safe in patients with quiescent systemic lupus erythematosus, but may be less effective than in healthy controls, reported Dr. A. Holvast of the University of Groningen, the Netherlands, and colleagues.

They studied 56 SLE patients with quiescent disease who were divided into groups based on their use of immunosuppressive drugs, with 12 using no drugs, 17 using hydroxychloroquine (at least 400 mg/day), 13 using azathioprine (at least 50 mg/day), and 14 using prednisone (at least 10 mg/day) (Ann. Rheum. Dis. 2006; 65:913–8).

All patients, along with 18 healthy controls, were vaccinated in October and November of 2003 with Influvac (Solvay Pharmaceuticals Inc.), a trivalent influenza vaccine. At 30 days after vaccination, the SLE disease activity index had not changed in any of the patient groups, and there were no significant changes in patient-recorded visual analogue scores—suggesting that vaccination did not induce disease activity.

Compared with controls, SLE patients had more systemic side effects of vaccination, although these were all mild. After excluding all subjects who had been vaccinated the previous year, the researchers found that significantly fewer SLE patients achieved seroconversions and protective titers to A/H1N1 and A/H3N2.

“It is conceivable that SLE patients have an intrinsic [immunologic] defect that results in decreased responsiveness to vaccination,” the authors wrote, adding that the use of immunosuppressive drugs may further decrease the vaccination response in these patients. There was a trend toward a further decrease in the vaccine's efficacy among systemic lupus erythematosus (SLE) patients taking azathioprine, compared with several other immunosuppressive drugs.

Vaccine Refusal Tied to Measles Cases

The vast majority of the people infected last year in the largest documented measles outbreak to hit the United States in a decade were children whose parents had objected to immunization.

The Indiana outbreak, which involved 34 people, “shows that states, localities, and health care organizations need to implement more effective policies to protect persons traveling abroad, home-schooled children, and health care workers against measles and other vaccine-preventable diseases,” wrote Amy A. Parker of the Centers for Disease Control and Prevention in Atlanta, and her associates.

Of the 34 infections, 32 were in people who had never been vaccinated for measles; 30 of the patients (88%) were children aged 19 years or younger.

“Concern about adverse events, particularly related to media reports of a putative association between vaccinations and autism and of the dangers of thimerosal, appeared to play a major role in the decision of these families to decline vaccination,” the investigators found (N. Engl. J. Med. 2006;355:447–55).

“As long as some groups within a given community respond to spurious claims about the risks of the vaccine by refusing to vaccinate their infants, further outbreaks will occur,” said Dr. E. Kim Mulholland, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, in a commentary that ran with the article (N. Engl. J. Med. 2006;355:440–3).

Mistaken Menactra Still Protective

Persons who mistakenly received the meningococcal conjugate vaccine (Menactra) subcutaneously rather than intramuscularly were nonetheless sufficiently protected, according to a report by the Centers for Disease Control and Prevention.

The CDC received reports that 101 persons aged 11–47 years (median age 17.5) in seven states received the new meningococcal vaccine (MCV4) subcutaneously, although it is licensed for intramuscular use only. Of the 38 individuals who agreed to participate in a study, 36 were protected for each of the four vaccine subgroups (A, C, Y, and W-135). Two patients failed to achieve protective titers against a single serogroup (serogroup C in one case and serogroup W-135 in the other).

The geometric mean titers (GMTs) were significantly lower for the subcutaneous vaccinees, compared with age-matched intramuscular vaccinees from the MCV4 clinical trials, for serogroups A, C, and Y, but there were no significant differences in GMTs for serogroup W-135 (MMWR 2006;55:1016–7).

Based on these findings, the researchers did not recommend revaccination for any of the subcutaneous vaccinees.

The meningococcal polysaccharide vaccine, which has been used for 30 years, is licensed for subcutaneous use, not intramuscular use, and this is the most likely reason for the misadministration of MCV4, according to the health care providers involved in the study.

Flu Vaccine Less Effective in SLE

Influenza vaccination appears to be safe in patients with quiescent systemic lupus erythematosus, but may be less effective than in healthy controls, reported Dr. A. Holvast of the University of Groningen, the Netherlands, and colleagues.

They studied 56 SLE patients with quiescent disease who were divided into groups based on their use of immunosuppressive drugs, with 12 using no drugs, 17 using hydroxychloroquine (at least 400 mg/day), 13 using azathioprine (at least 50 mg/day), and 14 using prednisone (at least 10 mg/day) (Ann. Rheum. Dis. 2006; 65:913–8).

All patients, along with 18 healthy controls, were vaccinated in October and November of 2003 with Influvac (Solvay Pharmaceuticals Inc.), a trivalent influenza vaccine. At 30 days after vaccination, the SLE disease activity index had not changed in any of the patient groups, and there were no significant changes in patient-recorded visual analogue scores—suggesting that vaccination did not induce disease activity.

Compared with controls, SLE patients had more systemic side effects of vaccination, although these were all mild. After excluding all subjects who had been vaccinated the previous year, the researchers found that significantly fewer SLE patients achieved seroconversions and protective titers to A/H1N1 and A/H3N2.

“It is conceivable that SLE patients have an intrinsic [immunologic] defect that results in decreased responsiveness to vaccination,” the authors wrote, adding that the use of immunosuppressive drugs may further decrease the vaccination response in these patients. There was a trend toward a further decrease in the vaccine's efficacy among systemic lupus erythematosus (SLE) patients taking azathioprine, compared with several other immunosuppressive drugs.

Vaccine Refusal Tied to Measles Cases

The vast majority of the people infected last year in the largest documented measles outbreak to hit the United States in a decade were children whose parents had objected to immunization.

The Indiana outbreak, which involved 34 people, “shows that states, localities, and health care organizations need to implement more effective policies to protect persons traveling abroad, home-schooled children, and health care workers against measles and other vaccine-preventable diseases,” wrote Amy A. Parker of the Centers for Disease Control and Prevention in Atlanta, and her associates.

Of the 34 infections, 32 were in people who had never been vaccinated for measles; 30 of the patients (88%) were children aged 19 years or younger.

“Concern about adverse events, particularly related to media reports of a putative association between vaccinations and autism and of the dangers of thimerosal, appeared to play a major role in the decision of these families to decline vaccination,” the investigators found (N. Engl. J. Med. 2006;355:447–55).

“As long as some groups within a given community respond to spurious claims about the risks of the vaccine by refusing to vaccinate their infants, further outbreaks will occur,” said Dr. E. Kim Mulholland, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, in a commentary that ran with the article (N. Engl. J. Med. 2006;355:440–3).