Denise Napoli

Each beach vacation from birth to age 6 by white Colorado children was associated with a 5% increase in small nevi when the children were examined at age 7, but not with large nevi development.

In addition, the total estimated UV dose received on waterside vacations and the number of days spent on vacation were not significantly related to nevi count, suggesting that a threshold dose of UV exposure is received relatively early during each waterside vacation, such that 3-day-long getaways may have the same effect on nevi development as 10-day trips, according to the authors.

Although it is the larger nevi (greater than or equal to 2 mm) that are most commonly associated with skin cancer, increased numbers of small nevi in childhood also confer melanoma risk.

“Parents should be aware of the effect that vacations may have on their children's risk for developing melanoma as adults, and they should be cautious about selection of vacation locations,” wrote Dr. Kelly J. Pettijohn, the study's lead author, from the department of community and behavioral health at the Colorado School of Public Health, Denver, and associates.

A total of 681 children born in 1998 who were lifetime residents of Colorado were studied.

Patients' parents were asked in 20- to 30-minute phone interviews about the child's vacation history, sunburn history, and demographic data. Skin exams were also conducted in 2005, when the patients were 7 years old, and nevi were grouped into two categories: less than 2 mm, or greater than or equal to 2 mm (Cancer Epidemiol. Biomarkers Prev. 2009;18:454–63).

Vacations were classified as either “waterside” or “nonwaterside” depending on their location.

For example, all vacations to Miami were considered waterside because it is assumed that the child would have spent a large amount of time in the sun with minimal clothing coverage. Some locations were considered waterside only in the summer season—for example, Duck, N.C.

And other locations, though technically waterside, were included in the nonwaterside category because they are not typically associated with water activities that lead to sun exposure in any season of the year; San Francisco fell into this category.

A history of severe sunburn, of sunscreen use, of hat use, or of sun sensitivity failed to predict the development of nevi. “The only significant linear relationship between vacations and nevi less than 2 mm was for number of waterside vacations before age 6,” wrote the authors. Each vacation was associated with a 5% increase in these small nevi after other factors were controlled for.

In addition, the authors found that waterside vacations taken within 1 year of the skin exam did not affect small nevi counts.

This finding suggests a time lag of at least 1 year may be necessary for the effects of sun exposure during waterside vacations to result in new nevi, they noted. Alternatively, the finding could be due to a physiologic change in childrens' melanocytes, “which become less susceptible to the intense sun exposure received on waterside vacations as [children] age.”

The obvious limitations of this study, including the lack of behavioral information (for instance, on the exact amount of time spent outside while on vacation, the type of clothing worn, or the sun protection practices used), as well as reliance on parent recall, are countered by the study's strengths. “It is one of the few large longitudinal cohort studies of nevus development in children,” said the authors, and it is the only one to report the link between vacations and nevi in North American subjects.

The authors reported no potential conflicts of interest related to this story.

“Parents should be aware of the effect that vacations may have on their children's” melanoma risk, warned an investigator. LOUISE A. KOENIG/ELSEVIER GLOBAL MEDICAL NEWS

Each beach vacation from birth to age 6 by white Colorado children was associated with a 5% increase in small nevi when the children were examined at age 7, but not with large nevi development.

In addition, the total estimated UV dose received on waterside vacations and the number of days spent on vacation were not significantly related to nevi count, suggesting that a threshold dose of UV exposure is received relatively early during each waterside vacation, such that 3-day-long getaways may have the same effect on nevi development as 10-day trips, according to the authors.

Although it is the larger nevi (greater than or equal to 2 mm) that are most commonly associated with skin cancer, increased numbers of small nevi in childhood also confer melanoma risk.

“Parents should be aware of the effect that vacations may have on their children's risk for developing melanoma as adults, and they should be cautious about selection of vacation locations,” wrote Dr. Kelly J. Pettijohn, the study's lead author, from the department of community and behavioral health at the Colorado School of Public Health, Denver, and associates.

A total of 681 children born in 1998 who were lifetime residents of Colorado were studied.

Patients' parents were asked in 20- to 30-minute phone interviews about the child's vacation history, sunburn history, and demographic data. Skin exams were also conducted in 2005, when the patients were 7 years old, and nevi were grouped into two categories: less than 2 mm, or greater than or equal to 2 mm (Cancer Epidemiol. Biomarkers Prev. 2009;18:454–63).

Vacations were classified as either “waterside” or “nonwaterside” depending on their location.

For example, all vacations to Miami were considered waterside because it is assumed that the child would have spent a large amount of time in the sun with minimal clothing coverage. Some locations were considered waterside only in the summer season—for example, Duck, N.C.

And other locations, though technically waterside, were included in the nonwaterside category because they are not typically associated with water activities that lead to sun exposure in any season of the year; San Francisco fell into this category.

A history of severe sunburn, of sunscreen use, of hat use, or of sun sensitivity failed to predict the development of nevi. “The only significant linear relationship between vacations and nevi less than 2 mm was for number of waterside vacations before age 6,” wrote the authors. Each vacation was associated with a 5% increase in these small nevi after other factors were controlled for.

In addition, the authors found that waterside vacations taken within 1 year of the skin exam did not affect small nevi counts.

This finding suggests a time lag of at least 1 year may be necessary for the effects of sun exposure during waterside vacations to result in new nevi, they noted. Alternatively, the finding could be due to a physiologic change in childrens' melanocytes, “which become less susceptible to the intense sun exposure received on waterside vacations as [children] age.”

The obvious limitations of this study, including the lack of behavioral information (for instance, on the exact amount of time spent outside while on vacation, the type of clothing worn, or the sun protection practices used), as well as reliance on parent recall, are countered by the study's strengths. “It is one of the few large longitudinal cohort studies of nevus development in children,” said the authors, and it is the only one to report the link between vacations and nevi in North American subjects.

The authors reported no potential conflicts of interest related to this story.

“Parents should be aware of the effect that vacations may have on their children's” melanoma risk, warned an investigator. LOUISE A. KOENIG/ELSEVIER GLOBAL MEDICAL NEWS

Each beach vacation from birth to age 6 by white Colorado children was associated with a 5% increase in small nevi when the children were examined at age 7, but not with large nevi development.

In addition, the total estimated UV dose received on waterside vacations and the number of days spent on vacation were not significantly related to nevi count, suggesting that a threshold dose of UV exposure is received relatively early during each waterside vacation, such that 3-day-long getaways may have the same effect on nevi development as 10-day trips, according to the authors.

Although it is the larger nevi (greater than or equal to 2 mm) that are most commonly associated with skin cancer, increased numbers of small nevi in childhood also confer melanoma risk.

“Parents should be aware of the effect that vacations may have on their children's risk for developing melanoma as adults, and they should be cautious about selection of vacation locations,” wrote Dr. Kelly J. Pettijohn, the study's lead author, from the department of community and behavioral health at the Colorado School of Public Health, Denver, and associates.

A total of 681 children born in 1998 who were lifetime residents of Colorado were studied.

Patients' parents were asked in 20- to 30-minute phone interviews about the child's vacation history, sunburn history, and demographic data. Skin exams were also conducted in 2005, when the patients were 7 years old, and nevi were grouped into two categories: less than 2 mm, or greater than or equal to 2 mm (Cancer Epidemiol. Biomarkers Prev. 2009;18:454–63).

Vacations were classified as either “waterside” or “nonwaterside” depending on their location.

For example, all vacations to Miami were considered waterside because it is assumed that the child would have spent a large amount of time in the sun with minimal clothing coverage. Some locations were considered waterside only in the summer season—for example, Duck, N.C.

And other locations, though technically waterside, were included in the nonwaterside category because they are not typically associated with water activities that lead to sun exposure in any season of the year; San Francisco fell into this category.

A history of severe sunburn, of sunscreen use, of hat use, or of sun sensitivity failed to predict the development of nevi. “The only significant linear relationship between vacations and nevi less than 2 mm was for number of waterside vacations before age 6,” wrote the authors. Each vacation was associated with a 5% increase in these small nevi after other factors were controlled for.

In addition, the authors found that waterside vacations taken within 1 year of the skin exam did not affect small nevi counts.

This finding suggests a time lag of at least 1 year may be necessary for the effects of sun exposure during waterside vacations to result in new nevi, they noted. Alternatively, the finding could be due to a physiologic change in childrens' melanocytes, “which become less susceptible to the intense sun exposure received on waterside vacations as [children] age.”

The obvious limitations of this study, including the lack of behavioral information (for instance, on the exact amount of time spent outside while on vacation, the type of clothing worn, or the sun protection practices used), as well as reliance on parent recall, are countered by the study's strengths. “It is one of the few large longitudinal cohort studies of nevus development in children,” said the authors, and it is the only one to report the link between vacations and nevi in North American subjects.

The authors reported no potential conflicts of interest related to this story.

“Parents should be aware of the effect that vacations may have on their children's” melanoma risk, warned an investigator. LOUISE A. KOENIG/ELSEVIER GLOBAL MEDICAL NEWS

Follow-on biologics legislation without a long period of data exclusivity for the original drug would significantly hinder future innovation, according to one economist.

Meanwhile, legislators' insistence that incentives for innovation be balanced with generics' promise of affordability means that a regulatory pathway for the drugs could remain uncharted in 2009.

Data exclusivity for follow-on biologics is the “period of time after [a biologic drug's] approval before a follow-on biologic can enter the market with an abbreviated filing” that relies on the original drug's safety and efficacy data, said Henry G. Grabowski, Ph.D., at a recent audioconference sponsored by Avalere Health LLC, a health care consultancy.

Because a “typical” new biologic drug might cost up to $1.2 billion in research and development, the “data exclusivity [period] acts as an insurance policy to ensure that there is adequate incentive” to produce the drugs in the first place, said Dr. Grabowski, a professor of economics and director of the program in pharmaceuticals and health economics at Duke University in Durham, N.C.

Ann Witt, a health care adviser to Rep. Henry Waxman (D-Calif.), who cosponsored the 1984 generic drugs legislation, disagreed with Dr. Grabowski's assessment. “Many of the arguments we heard here today were also made in 1984 by the then-manufacturers of small molecule drugs, who insisted that innovation would come to an end” with the advent of generics, she pointed out. Since then, “I have never heard anyone claim that that bill reduced innovation in the pharmaceutical industry,” she said.

The Food and Drug Administration's stance seems to side with Dr. Grabowski and the drugmakers. A Sept. 18, 2008, letter from the FDA's then-chief scientist, Dr. Frank M. Torti, states: “The Agency believes that sponsors that develop innovative biotechnology products should be eligible for a significant period of market and/or data exclusivity, independent from any patent protections that might be applicable to the product, to ensure continued innovation.”

Dr. Torti has since taken over as the FDA's acting commissioner.

The letter was addressed to the chairman of the House Subcommittee on Health, Rep. Frank Pallone Jr. (D-N.J.). The subcommittee is a division of the House Committee on Energy and Commerce, of which Rep. Waxman was recently appointed chairman. Ms. Witt said that legislation supporting a follow-on biologics pathway would be a high priority for the committee in 2009.

Follow-on biologics legislation without a long period of data exclusivity for the original drug would significantly hinder future innovation, according to one economist.

Meanwhile, legislators' insistence that incentives for innovation be balanced with generics' promise of affordability means that a regulatory pathway for the drugs could remain uncharted in 2009.

Data exclusivity for follow-on biologics is the “period of time after [a biologic drug's] approval before a follow-on biologic can enter the market with an abbreviated filing” that relies on the original drug's safety and efficacy data, said Henry G. Grabowski, Ph.D., at a recent audioconference sponsored by Avalere Health LLC, a health care consultancy.

Because a “typical” new biologic drug might cost up to $1.2 billion in research and development, the “data exclusivity [period] acts as an insurance policy to ensure that there is adequate incentive” to produce the drugs in the first place, said Dr. Grabowski, a professor of economics and director of the program in pharmaceuticals and health economics at Duke University in Durham, N.C.

Ann Witt, a health care adviser to Rep. Henry Waxman (D-Calif.), who cosponsored the 1984 generic drugs legislation, disagreed with Dr. Grabowski's assessment. “Many of the arguments we heard here today were also made in 1984 by the then-manufacturers of small molecule drugs, who insisted that innovation would come to an end” with the advent of generics, she pointed out. Since then, “I have never heard anyone claim that that bill reduced innovation in the pharmaceutical industry,” she said.

The Food and Drug Administration's stance seems to side with Dr. Grabowski and the drugmakers. A Sept. 18, 2008, letter from the FDA's then-chief scientist, Dr. Frank M. Torti, states: “The Agency believes that sponsors that develop innovative biotechnology products should be eligible for a significant period of market and/or data exclusivity, independent from any patent protections that might be applicable to the product, to ensure continued innovation.”

Dr. Torti has since taken over as the FDA's acting commissioner.

The letter was addressed to the chairman of the House Subcommittee on Health, Rep. Frank Pallone Jr. (D-N.J.). The subcommittee is a division of the House Committee on Energy and Commerce, of which Rep. Waxman was recently appointed chairman. Ms. Witt said that legislation supporting a follow-on biologics pathway would be a high priority for the committee in 2009.

Follow-on biologics legislation without a long period of data exclusivity for the original drug would significantly hinder future innovation, according to one economist.

Meanwhile, legislators' insistence that incentives for innovation be balanced with generics' promise of affordability means that a regulatory pathway for the drugs could remain uncharted in 2009.

Data exclusivity for follow-on biologics is the “period of time after [a biologic drug's] approval before a follow-on biologic can enter the market with an abbreviated filing” that relies on the original drug's safety and efficacy data, said Henry G. Grabowski, Ph.D., at a recent audioconference sponsored by Avalere Health LLC, a health care consultancy.

Because a “typical” new biologic drug might cost up to $1.2 billion in research and development, the “data exclusivity [period] acts as an insurance policy to ensure that there is adequate incentive” to produce the drugs in the first place, said Dr. Grabowski, a professor of economics and director of the program in pharmaceuticals and health economics at Duke University in Durham, N.C.

Ann Witt, a health care adviser to Rep. Henry Waxman (D-Calif.), who cosponsored the 1984 generic drugs legislation, disagreed with Dr. Grabowski's assessment. “Many of the arguments we heard here today were also made in 1984 by the then-manufacturers of small molecule drugs, who insisted that innovation would come to an end” with the advent of generics, she pointed out. Since then, “I have never heard anyone claim that that bill reduced innovation in the pharmaceutical industry,” she said.

The Food and Drug Administration's stance seems to side with Dr. Grabowski and the drugmakers. A Sept. 18, 2008, letter from the FDA's then-chief scientist, Dr. Frank M. Torti, states: “The Agency believes that sponsors that develop innovative biotechnology products should be eligible for a significant period of market and/or data exclusivity, independent from any patent protections that might be applicable to the product, to ensure continued innovation.”

Dr. Torti has since taken over as the FDA's acting commissioner.

The letter was addressed to the chairman of the House Subcommittee on Health, Rep. Frank Pallone Jr. (D-N.J.). The subcommittee is a division of the House Committee on Energy and Commerce, of which Rep. Waxman was recently appointed chairman. Ms. Witt said that legislation supporting a follow-on biologics pathway would be a high priority for the committee in 2009.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.

Two forms of postnatal intervention—one with trained nurses or midwives, and another with a peer—significantly reduced the likelihood of postnatal depression, according to recent research.

The studies “add to the growing evidence that postnatal depression can be effectively treated and possibly prevented,” Dr. Cindy-Lee Dennis of the department of psychiatry at the University of Toronto and one of the lead investigators, wrote in an accompanying editorial (BMJ 2009:338:a3045 [doi:10.1136/bmj.a3064]).

The first study assessed the impact of a postnatal intervention conducted by trained “health visitors.” In the United Kingdom, health visitors are registered nurses or midwives who postnatally work with mothers on feeding, safety, physical and emotional development, and other aspects of health and child care, according to the National Health Service Web site.

The health visitors were “trained to identify depressive symptoms using the Edinburgh postnatal depression scale (EPDS) and to use clinical assessment skills to assess a mother's mood, including suicidal thoughts,” wrote Dr. C. Jane Morrell of the University of Huddersfield (England) and her colleagues (BMJ 2009;338:a3045 [doi:10.1136/bmj.a3045]).

The health visitors provided weekly 1-hour counseling sessions in the mother's home for up to 8 weeks, starting at 8 weeks postnatally. A control group was given usual care, without the in-home psychological sessions.

A total of 4,084 eligible women consented to participate, and 595 had a 6-week EPDS score greater than or equal to 12, which indicates the possibility of depression. The maximum score is 30.

Ultimately, 418 women who participated in the program had follow-up EPDS scores at 6 months and were analyzed.

At 6 months, the authors reported that the 271 women in the intervention group whose 6-week score had been greater than or equal to 12 were 40% less likely to have a score greater than or equal to 12, compared with the 147 women in the control group.

Furthermore, wrote Dr. Morrell and her associates, “the differences in the mean EPDS scores at 6 months … were sustained at 12 months.”

The trial “provides new evidence of the effectiveness of a package of training for health visitors to identify symptoms of depression postnatally and to provide psychologically informed sessions,” wrote the authors. They declared no competing interests and wrote that the study was funded entirely by the NHS.

The second randomized, controlled trial looked at the impact of a telephone-based intervention with nonmedical professional peers for postnatal women with an EPDS greater than 12.

A total of 315 women received usual care with follow-up information available at 12 weeks. Usual care “could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources.”

In contrast, the 297 women who were randomized to the intervention group and had follow-up data at 12 weeks received usual care plus telephone access to a peer volunteer—a mother who had personally experienced postnatal depression.

The volunteers were trained in providing telephone-based support and made referrals to health care professionals, if necessary, and in role playing.

A minimum of four contacts between the mother and peer volunteer were made.

“Women in the intervention group were significantly less likely to have symptoms of postnatal depression at the 12-week assessment than [were] those in the control group (odds ratio 2.1),” wrote the authors, led by Dr. Dennis.

“Specifically, 14% (40/297) of women in the intervention group had a score greater than 12, compared with 25% (78/315) in the control group.”

More than 80% of the 221 women who received peer counseling and evaluated their experience said that they would recommend the support to a friend and that they were satisfied with the experience.

Dr. Dennis disclosed having no individual competing interests.

Her study was supported by the Canadian Institutes of Health.

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over use of tumor necrosis factor blockers in pregnancy.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population.

Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies, said in an interview that “the FDA database serves an important role.” However, he agreed that the database has incomplete and biased data.

“There is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” he said.

Neither the American College of Rheumatology nor the European League Against Rheumatism have any guidelines concerning treatment during pregnancy, added Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005. A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers took etanercept at some point in pregnancy; 19 took infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum (vertebral abnormalities, anal atresia, cardiac defect, tracheoesophageal, renal, and limb abnormalities). “Since congenital anomalies are present in 3%-5% of all live births, and VACTERL occurs in 1.6/10,000 live births, you would expect to see [about] 1.6 cases of VACTERL association in every 300–500 children born with congenital anomalies,” wrote the authors. “We have now seen 2/42 (4.8%) cases of VACTERL” (including 1 case outside of the study period).

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include a case as part of the VACTERL spectrum they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only 1 was diagnosed with the pattern of associated birth defects within the original study period, said Dr. Chambers.

Dr. Cush pointed out that there are currently no studies that address the potential effects of stopping anti-TNF therapy before pregnancy, though it could be hazardous. Furthermore, the lack of alternative therapies that approximate the effect of anti-TNFs on disease means that clinicians may have to lean on palliative agents such as prednisone and NSAIDs, “both of which also pose potential harms to mother and child.”

Dr. Carter did not declare any conflicts of interest. Dr. Chambers said she did not have any personal conflicts, but OTIS receives grant funding from nine drug companies, two of which make anti-TNFs. Dr. Cush has served as a consultant or adviser to, or received grant money from, multiple drug companies, including the makers of anti-TNFs.

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over use of tumor necrosis factor blockers in pregnancy.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population.

Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies, said in an interview that “the FDA database serves an important role.” However, he agreed that the database has incomplete and biased data.

“There is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” he said.

Neither the American College of Rheumatology nor the European League Against Rheumatism have any guidelines concerning treatment during pregnancy, added Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005. A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers took etanercept at some point in pregnancy; 19 took infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum (vertebral abnormalities, anal atresia, cardiac defect, tracheoesophageal, renal, and limb abnormalities). “Since congenital anomalies are present in 3%-5% of all live births, and VACTERL occurs in 1.6/10,000 live births, you would expect to see [about] 1.6 cases of VACTERL association in every 300–500 children born with congenital anomalies,” wrote the authors. “We have now seen 2/42 (4.8%) cases of VACTERL” (including 1 case outside of the study period).

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include a case as part of the VACTERL spectrum they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only 1 was diagnosed with the pattern of associated birth defects within the original study period, said Dr. Chambers.

Dr. Cush pointed out that there are currently no studies that address the potential effects of stopping anti-TNF therapy before pregnancy, though it could be hazardous. Furthermore, the lack of alternative therapies that approximate the effect of anti-TNFs on disease means that clinicians may have to lean on palliative agents such as prednisone and NSAIDs, “both of which also pose potential harms to mother and child.”

Dr. Carter did not declare any conflicts of interest. Dr. Chambers said she did not have any personal conflicts, but OTIS receives grant funding from nine drug companies, two of which make anti-TNFs. Dr. Cush has served as a consultant or adviser to, or received grant money from, multiple drug companies, including the makers of anti-TNFs.

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over use of tumor necrosis factor blockers in pregnancy.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population.

Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies, said in an interview that “the FDA database serves an important role.” However, he agreed that the database has incomplete and biased data.

“There is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” he said.

Neither the American College of Rheumatology nor the European League Against Rheumatism have any guidelines concerning treatment during pregnancy, added Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005. A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers took etanercept at some point in pregnancy; 19 took infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum (vertebral abnormalities, anal atresia, cardiac defect, tracheoesophageal, renal, and limb abnormalities). “Since congenital anomalies are present in 3%-5% of all live births, and VACTERL occurs in 1.6/10,000 live births, you would expect to see [about] 1.6 cases of VACTERL association in every 300–500 children born with congenital anomalies,” wrote the authors. “We have now seen 2/42 (4.8%) cases of VACTERL” (including 1 case outside of the study period).

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include a case as part of the VACTERL spectrum they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only 1 was diagnosed with the pattern of associated birth defects within the original study period, said Dr. Chambers.

Dr. Cush pointed out that there are currently no studies that address the potential effects of stopping anti-TNF therapy before pregnancy, though it could be hazardous. Furthermore, the lack of alternative therapies that approximate the effect of anti-TNFs on disease means that clinicians may have to lean on palliative agents such as prednisone and NSAIDs, “both of which also pose potential harms to mother and child.”

Dr. Carter did not declare any conflicts of interest. Dr. Chambers said she did not have any personal conflicts, but OTIS receives grant funding from nine drug companies, two of which make anti-TNFs. Dr. Cush has served as a consultant or adviser to, or received grant money from, multiple drug companies, including the makers of anti-TNFs.

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase?

“We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side–about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect–only 1 month–a set of health spending projections for 2008-2018 will be released some time in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase?

“We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side–about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect–only 1 month–a set of health spending projections for 2008-2018 will be released some time in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase?

“We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side–about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect–only 1 month–a set of health spending projections for 2008-2018 will be released some time in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”

Pediatric obesity clinics aiming to get children healthy are springing up across the country. Although some physicians hope the trend continues, the programs are not without problems: a hefty price tag, for one, and a dearth of long-term data.

One program that does have long-term data is the nationwide KidShape, founded in 1986 at Cedars-Sinai Medical Center in Los Angeles by Dr. Naomi Neufeld. The program, which focuses on healthy lifestyles, results in an average 0.6-point decrease in patients' body mass index over the 9-week course, with 80% of the youngsters maintaining or continuing to improve their BMI at 2 years, she said.

“I don't think any of these programs cure obesity,” said Dr. George Datto, a pediatrician and director of the adolescent bariatric program at Alfred I. duPont Hospital in Wilmington, Del. “If parents think they will drop their kid off, and at the end of 8 weeks the problem will be gone–that's not the way these things work.

“But they're good for education,” he added. “It's a tool to help you change your lifestyle.”

One of the newer programs is Boston-based Great Moves! According to Dr. Erinn Rhodes, a pediatric endocrinologist and chief medical officer of Great Moves!, “We intentionally don't focus on weight in the program. What we focus on are healthy lifestyles,” she said in an interview.

According to both Dr. Rhodes and Dr. Neufeld, a pediatric endocrinologist in Los Angeles, the most successful programs provide support in four key areas: healthy diet and physical activity, to be sure, but also mental health support and–perhaps most crucially–the importance of parental involvement in weight loss.

“If you're getting the whole family to buy in, that's really the key,” said Dr. Neufeld. “You can show parents where they're sabotaging their child's best efforts.” Clinics that don't have parental involvement waste 50% of their effort, she said in an interview. At Great Moves!, the parents' BMIs are monitored right alongside those of the children.

Both programs employ on-site dieticians and nutrition experts. At Great Moves!, clinic director and dietician Suzanne Rostler said, “We do a basic Nutrition 101.” In the on-site kitchen, children and parents learn how to make healthy, balanced meals or snacks–“a healthy carbohydrate, plus a lean protein or a healthy fat.”

The mental health professionals employed by both clinics are another reason for their success, said Dr. Neufeld. “A lot of kids who are overweight are turning to food for a lot more reasons than just boredom. And it's good to have other people around that they can talk to about it.”

Physician involvement also is important to both programs.

At Great Moves!, families meet individually with a physician at least three times throughout the program. “The beginning [visit] is intended to evaluate whether there is any underlying medical reason that may be contributing to [the child's] overweight or obesity, look for complications as a result [of the obesity], and make sure that if there are any secondary medical issues that they have that are unrelated to obesity, we know about them,” said Dr. Rhodes. Other visits are for follow-up.

Although KidShape clinics do not schedule mandatory visits with on-site physicians, many of the clinics have MDs serving as director, “spearheading the program,” said Christiane Wert Rivard, a program director at KidShape. They also coordinate with referring physicians.

The weekly physical activity sessions, involving nontraditional, “kid-friendly” sports and games, also are key. At Great Moves!, Dr. Rhodes stressed that there are no treadmills or exercise bikes.

KidShape, similarly, involves its participants in weekly karate, kickboxing, and tae kwon do sessions.

This kind of exercise approach is essential for pediatric weight loss success, said Dr. Donald Bergman, an endocrinologist in private practice in New York who is not affiliated with the clinics. “Children need to be active in small doses; they need to vary the activity so that it is fun.” Parents who seek to exercise with their children should vary activities every 15 minutes, he said in an interview.

Pediatric weight loss clinics like these are not all fun and games, however. There is the matter of the bill, which is often not covered by insurance companies.

Indeed, at Great Moves!, the cost is significant: $300 for an initial assessment followed by six payments ranging between $300 and $450, depending on the degree of program participation, said Stanley Goldstein, Great Moves! CEO. A reduced-cost version of the program without physician supervision is in the works, as are negotiations with insurers.

At KidShape, Dr. Neufeld has been somewhat successful at getting private insurers to cover at least some of the cost. To do so, she works to identify some of the comorbidities that obese and overweight children face.

No treadmills or exercise bikes here. The focus on physical activity sessions at Great Moves! is on kid-friendly sports and games.

In an on-site kitchen at Great Moves! in Boston, a child learns how to make a healthier pizza. Photos courtesy Great Moves!

Pediatric obesity clinics aiming to get children healthy are springing up across the country. Although some physicians hope the trend continues, the programs are not without problems: a hefty price tag, for one, and a dearth of long-term data.

One program that does have long-term data is the nationwide KidShape, founded in 1986 at Cedars-Sinai Medical Center in Los Angeles by Dr. Naomi Neufeld. The program, which focuses on healthy lifestyles, results in an average 0.6-point decrease in patients' body mass index over the 9-week course, with 80% of the youngsters maintaining or continuing to improve their BMI at 2 years, she said.

“I don't think any of these programs cure obesity,” said Dr. George Datto, a pediatrician and director of the adolescent bariatric program at Alfred I. duPont Hospital in Wilmington, Del. “If parents think they will drop their kid off, and at the end of 8 weeks the problem will be gone–that's not the way these things work.

“But they're good for education,” he added. “It's a tool to help you change your lifestyle.”

One of the newer programs is Boston-based Great Moves! According to Dr. Erinn Rhodes, a pediatric endocrinologist and chief medical officer of Great Moves!, “We intentionally don't focus on weight in the program. What we focus on are healthy lifestyles,” she said in an interview.

According to both Dr. Rhodes and Dr. Neufeld, a pediatric endocrinologist in Los Angeles, the most successful programs provide support in four key areas: healthy diet and physical activity, to be sure, but also mental health support and–perhaps most crucially–the importance of parental involvement in weight loss.

“If you're getting the whole family to buy in, that's really the key,” said Dr. Neufeld. “You can show parents where they're sabotaging their child's best efforts.” Clinics that don't have parental involvement waste 50% of their effort, she said in an interview. At Great Moves!, the parents' BMIs are monitored right alongside those of the children.

Both programs employ on-site dieticians and nutrition experts. At Great Moves!, clinic director and dietician Suzanne Rostler said, “We do a basic Nutrition 101.” In the on-site kitchen, children and parents learn how to make healthy, balanced meals or snacks–“a healthy carbohydrate, plus a lean protein or a healthy fat.”

The mental health professionals employed by both clinics are another reason for their success, said Dr. Neufeld. “A lot of kids who are overweight are turning to food for a lot more reasons than just boredom. And it's good to have other people around that they can talk to about it.”

Physician involvement also is important to both programs.

At Great Moves!, families meet individually with a physician at least three times throughout the program. “The beginning [visit] is intended to evaluate whether there is any underlying medical reason that may be contributing to [the child's] overweight or obesity, look for complications as a result [of the obesity], and make sure that if there are any secondary medical issues that they have that are unrelated to obesity, we know about them,” said Dr. Rhodes. Other visits are for follow-up.

Although KidShape clinics do not schedule mandatory visits with on-site physicians, many of the clinics have MDs serving as director, “spearheading the program,” said Christiane Wert Rivard, a program director at KidShape. They also coordinate with referring physicians.

The weekly physical activity sessions, involving nontraditional, “kid-friendly” sports and games, also are key. At Great Moves!, Dr. Rhodes stressed that there are no treadmills or exercise bikes.

KidShape, similarly, involves its participants in weekly karate, kickboxing, and tae kwon do sessions.

This kind of exercise approach is essential for pediatric weight loss success, said Dr. Donald Bergman, an endocrinologist in private practice in New York who is not affiliated with the clinics. “Children need to be active in small doses; they need to vary the activity so that it is fun.” Parents who seek to exercise with their children should vary activities every 15 minutes, he said in an interview.

Pediatric weight loss clinics like these are not all fun and games, however. There is the matter of the bill, which is often not covered by insurance companies.

Indeed, at Great Moves!, the cost is significant: $300 for an initial assessment followed by six payments ranging between $300 and $450, depending on the degree of program participation, said Stanley Goldstein, Great Moves! CEO. A reduced-cost version of the program without physician supervision is in the works, as are negotiations with insurers.

At KidShape, Dr. Neufeld has been somewhat successful at getting private insurers to cover at least some of the cost. To do so, she works to identify some of the comorbidities that obese and overweight children face.

No treadmills or exercise bikes here. The focus on physical activity sessions at Great Moves! is on kid-friendly sports and games.

In an on-site kitchen at Great Moves! in Boston, a child learns how to make a healthier pizza. Photos courtesy Great Moves!

Pediatric obesity clinics aiming to get children healthy are springing up across the country. Although some physicians hope the trend continues, the programs are not without problems: a hefty price tag, for one, and a dearth of long-term data.

One program that does have long-term data is the nationwide KidShape, founded in 1986 at Cedars-Sinai Medical Center in Los Angeles by Dr. Naomi Neufeld. The program, which focuses on healthy lifestyles, results in an average 0.6-point decrease in patients' body mass index over the 9-week course, with 80% of the youngsters maintaining or continuing to improve their BMI at 2 years, she said.

“I don't think any of these programs cure obesity,” said Dr. George Datto, a pediatrician and director of the adolescent bariatric program at Alfred I. duPont Hospital in Wilmington, Del. “If parents think they will drop their kid off, and at the end of 8 weeks the problem will be gone–that's not the way these things work.

“But they're good for education,” he added. “It's a tool to help you change your lifestyle.”

One of the newer programs is Boston-based Great Moves! According to Dr. Erinn Rhodes, a pediatric endocrinologist and chief medical officer of Great Moves!, “We intentionally don't focus on weight in the program. What we focus on are healthy lifestyles,” she said in an interview.

According to both Dr. Rhodes and Dr. Neufeld, a pediatric endocrinologist in Los Angeles, the most successful programs provide support in four key areas: healthy diet and physical activity, to be sure, but also mental health support and–perhaps most crucially–the importance of parental involvement in weight loss.

“If you're getting the whole family to buy in, that's really the key,” said Dr. Neufeld. “You can show parents where they're sabotaging their child's best efforts.” Clinics that don't have parental involvement waste 50% of their effort, she said in an interview. At Great Moves!, the parents' BMIs are monitored right alongside those of the children.

Both programs employ on-site dieticians and nutrition experts. At Great Moves!, clinic director and dietician Suzanne Rostler said, “We do a basic Nutrition 101.” In the on-site kitchen, children and parents learn how to make healthy, balanced meals or snacks–“a healthy carbohydrate, plus a lean protein or a healthy fat.”

The mental health professionals employed by both clinics are another reason for their success, said Dr. Neufeld. “A lot of kids who are overweight are turning to food for a lot more reasons than just boredom. And it's good to have other people around that they can talk to about it.”

Physician involvement also is important to both programs.

At Great Moves!, families meet individually with a physician at least three times throughout the program. “The beginning [visit] is intended to evaluate whether there is any underlying medical reason that may be contributing to [the child's] overweight or obesity, look for complications as a result [of the obesity], and make sure that if there are any secondary medical issues that they have that are unrelated to obesity, we know about them,” said Dr. Rhodes. Other visits are for follow-up.

Although KidShape clinics do not schedule mandatory visits with on-site physicians, many of the clinics have MDs serving as director, “spearheading the program,” said Christiane Wert Rivard, a program director at KidShape. They also coordinate with referring physicians.

The weekly physical activity sessions, involving nontraditional, “kid-friendly” sports and games, also are key. At Great Moves!, Dr. Rhodes stressed that there are no treadmills or exercise bikes.

KidShape, similarly, involves its participants in weekly karate, kickboxing, and tae kwon do sessions.

This kind of exercise approach is essential for pediatric weight loss success, said Dr. Donald Bergman, an endocrinologist in private practice in New York who is not affiliated with the clinics. “Children need to be active in small doses; they need to vary the activity so that it is fun.” Parents who seek to exercise with their children should vary activities every 15 minutes, he said in an interview.

Pediatric weight loss clinics like these are not all fun and games, however. There is the matter of the bill, which is often not covered by insurance companies.

Indeed, at Great Moves!, the cost is significant: $300 for an initial assessment followed by six payments ranging between $300 and $450, depending on the degree of program participation, said Stanley Goldstein, Great Moves! CEO. A reduced-cost version of the program without physician supervision is in the works, as are negotiations with insurers.

At KidShape, Dr. Neufeld has been somewhat successful at getting private insurers to cover at least some of the cost. To do so, she works to identify some of the comorbidities that obese and overweight children face.

No treadmills or exercise bikes here. The focus on physical activity sessions at Great Moves! is on kid-friendly sports and games.

In an on-site kitchen at Great Moves! in Boston, a child learns how to make a healthier pizza. Photos courtesy Great Moves!

WASHINGTON — Cryptococcus gattii, a meningitis-causing fungus previously confined to tropical and subtropical climates outside of the United States, has caused severe illness in at least 19 individuals—of whom 4 died—in the Pacific Northwest United States since 2006.

The infections were not predominately associated with immunocompromised individuals, unlike past, non-gattii cases of Cryptococcus infection in North America.

“Twelve of 19 individuals had a delay in diagnosis greater than a week,” Dr. Sarah West said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America. The delay was “in part probably because this was not on physicians' radars, and also because this is not something that our labs are routinely testing,” she said, speaking of a need for physicians, especially in that area, to be more aware of the infection.

The outbreak was previously reported on Vancouver Island in 1999, when more than 200 cases were identified. Although a C. gattii relative—Cryptococcus neoformans—is fairly well known in North America, C. gattii was “not previously described as causing significant disease in North America,” Dr. West said.

The variation is most often seen in Australia and in similarly tropical climates. It is not known why the fungus has spread to this new area, but climate change has been suggested as a factor.

Dr. West and her collaborators first had their interest piqued by a published 2006 case of a man from Puget Sound region of Washington state, who had pulmonary cryptococcoma and who was infected with C. gattii. “He had never traveled to Vancouver Island,” she said, though the C. gattii isolate was genetically identical to the Vancouver strain.

Since then, Dr. West has been querying physicians in Oregon and Washington, checking referrals to local tertiary-care hospitals, and relying on “word of mouth” to put together a retrospective study of 19 culture-confirmed C. gattii cases in the region from 2004 to the present. (Most microbiology labs do not routinely differentiate between C. neoformans and C. gattii in cultures, so the cases were culture confirmed in Dr. West's lab.)

“The bulk of cases were in 2007 and 2008,” she said. “At least three had traveled to British Columbia mainland, but none had documented travel to Vancouver Island.

“When we compared the Cryptococcus data from Oregon with our C. gattii cases, we saw some differences in the underlying conditions,” she said. Whereas about 78% of the non-gattii Cryptococcus cases in Oregon were associated with HIV, cancer, organ transplants, or some other immunosuppressing condition, “just under 40% of the gattii cases were associated with these diagnoses, and none of the patients with gattii were HIV positive.”

Their presenting symptoms were nonspecific, which probably led to delay in diagnosis, added Dr. West, of the Oregon Health and Science University, Portland. As on Vancouver Island, about 75% of cases were associated with pulmonary disease, including two cases of asymptomatic pulmonary nodules. The remaining 25% were associated with central nervous system disease alone. Overall, about 20% of patients had both CNS disease and pulmonary disease.

“Most of the patients with CNS disease had meningoencephalitis, often associated with severe and symptomatic increase in cranial pressure, and many required semipermanent drain placement,” Dr. West said.

Poor outcomes were seen in the 15 survivors, including long-term sequelae such as chronic headaches, vision and hearing loss, and recurrent hospital stays.

An audience member from the Centers for Disease Control and Prevention said the agency has formed a six-state public health working group for C. gattii and has identified cases in Montana and Idaho.

Enzon Pharmaceuticals Inc. supported Dr. West's study. She did not disclose conflicts of interest related to the study.

WASHINGTON — Cryptococcus gattii, a meningitis-causing fungus previously confined to tropical and subtropical climates outside of the United States, has caused severe illness in at least 19 individuals—of whom 4 died—in the Pacific Northwest United States since 2006.

The infections were not predominately associated with immunocompromised individuals, unlike past, non-gattii cases of Cryptococcus infection in North America.

“Twelve of 19 individuals had a delay in diagnosis greater than a week,” Dr. Sarah West said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America. The delay was “in part probably because this was not on physicians' radars, and also because this is not something that our labs are routinely testing,” she said, speaking of a need for physicians, especially in that area, to be more aware of the infection.

The outbreak was previously reported on Vancouver Island in 1999, when more than 200 cases were identified. Although a C. gattii relative—Cryptococcus neoformans—is fairly well known in North America, C. gattii was “not previously described as causing significant disease in North America,” Dr. West said.

The variation is most often seen in Australia and in similarly tropical climates. It is not known why the fungus has spread to this new area, but climate change has been suggested as a factor.

Dr. West and her collaborators first had their interest piqued by a published 2006 case of a man from Puget Sound region of Washington state, who had pulmonary cryptococcoma and who was infected with C. gattii. “He had never traveled to Vancouver Island,” she said, though the C. gattii isolate was genetically identical to the Vancouver strain.

Since then, Dr. West has been querying physicians in Oregon and Washington, checking referrals to local tertiary-care hospitals, and relying on “word of mouth” to put together a retrospective study of 19 culture-confirmed C. gattii cases in the region from 2004 to the present. (Most microbiology labs do not routinely differentiate between C. neoformans and C. gattii in cultures, so the cases were culture confirmed in Dr. West's lab.)

“The bulk of cases were in 2007 and 2008,” she said. “At least three had traveled to British Columbia mainland, but none had documented travel to Vancouver Island.

“When we compared the Cryptococcus data from Oregon with our C. gattii cases, we saw some differences in the underlying conditions,” she said. Whereas about 78% of the non-gattii Cryptococcus cases in Oregon were associated with HIV, cancer, organ transplants, or some other immunosuppressing condition, “just under 40% of the gattii cases were associated with these diagnoses, and none of the patients with gattii were HIV positive.”

Their presenting symptoms were nonspecific, which probably led to delay in diagnosis, added Dr. West, of the Oregon Health and Science University, Portland. As on Vancouver Island, about 75% of cases were associated with pulmonary disease, including two cases of asymptomatic pulmonary nodules. The remaining 25% were associated with central nervous system disease alone. Overall, about 20% of patients had both CNS disease and pulmonary disease.

“Most of the patients with CNS disease had meningoencephalitis, often associated with severe and symptomatic increase in cranial pressure, and many required semipermanent drain placement,” Dr. West said.

Poor outcomes were seen in the 15 survivors, including long-term sequelae such as chronic headaches, vision and hearing loss, and recurrent hospital stays.

An audience member from the Centers for Disease Control and Prevention said the agency has formed a six-state public health working group for C. gattii and has identified cases in Montana and Idaho.

Enzon Pharmaceuticals Inc. supported Dr. West's study. She did not disclose conflicts of interest related to the study.

WASHINGTON — Cryptococcus gattii, a meningitis-causing fungus previously confined to tropical and subtropical climates outside of the United States, has caused severe illness in at least 19 individuals—of whom 4 died—in the Pacific Northwest United States since 2006.

The infections were not predominately associated with immunocompromised individuals, unlike past, non-gattii cases of Cryptococcus infection in North America.

“Twelve of 19 individuals had a delay in diagnosis greater than a week,” Dr. Sarah West said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America. The delay was “in part probably because this was not on physicians' radars, and also because this is not something that our labs are routinely testing,” she said, speaking of a need for physicians, especially in that area, to be more aware of the infection.

The outbreak was previously reported on Vancouver Island in 1999, when more than 200 cases were identified. Although a C. gattii relative—Cryptococcus neoformans—is fairly well known in North America, C. gattii was “not previously described as causing significant disease in North America,” Dr. West said.

The variation is most often seen in Australia and in similarly tropical climates. It is not known why the fungus has spread to this new area, but climate change has been suggested as a factor.

Dr. West and her collaborators first had their interest piqued by a published 2006 case of a man from Puget Sound region of Washington state, who had pulmonary cryptococcoma and who was infected with C. gattii. “He had never traveled to Vancouver Island,” she said, though the C. gattii isolate was genetically identical to the Vancouver strain.

Since then, Dr. West has been querying physicians in Oregon and Washington, checking referrals to local tertiary-care hospitals, and relying on “word of mouth” to put together a retrospective study of 19 culture-confirmed C. gattii cases in the region from 2004 to the present. (Most microbiology labs do not routinely differentiate between C. neoformans and C. gattii in cultures, so the cases were culture confirmed in Dr. West's lab.)

“The bulk of cases were in 2007 and 2008,” she said. “At least three had traveled to British Columbia mainland, but none had documented travel to Vancouver Island.

“When we compared the Cryptococcus data from Oregon with our C. gattii cases, we saw some differences in the underlying conditions,” she said. Whereas about 78% of the non-gattii Cryptococcus cases in Oregon were associated with HIV, cancer, organ transplants, or some other immunosuppressing condition, “just under 40% of the gattii cases were associated with these diagnoses, and none of the patients with gattii were HIV positive.”

Their presenting symptoms were nonspecific, which probably led to delay in diagnosis, added Dr. West, of the Oregon Health and Science University, Portland. As on Vancouver Island, about 75% of cases were associated with pulmonary disease, including two cases of asymptomatic pulmonary nodules. The remaining 25% were associated with central nervous system disease alone. Overall, about 20% of patients had both CNS disease and pulmonary disease.

“Most of the patients with CNS disease had meningoencephalitis, often associated with severe and symptomatic increase in cranial pressure, and many required semipermanent drain placement,” Dr. West said.

Poor outcomes were seen in the 15 survivors, including long-term sequelae such as chronic headaches, vision and hearing loss, and recurrent hospital stays.

An audience member from the Centers for Disease Control and Prevention said the agency has formed a six-state public health working group for C. gattii and has identified cases in Montana and Idaho.

Enzon Pharmaceuticals Inc. supported Dr. West's study. She did not disclose conflicts of interest related to the study.

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

"Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?" asked Richard Foster, CMS chief actuary.

"Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem," he said.

The data indicate that most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963, said Mr. Foster.

In 2006, by contrast, spending on prescription drugs grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart), and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. ("Clinics" were defined as outpatient care centers and ambulatory service centers.)

As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008-2018 will be released some time this month.

Mr. Foster predicted that the projections will have much less of an upside. "I wouldn't expect the 6.1% to stay that low," he said. "I wouldn't expect the good news to continue."

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

"Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?" asked Richard Foster, CMS chief actuary.

"Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem," he said.

The data indicate that most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963, said Mr. Foster.

In 2006, by contrast, spending on prescription drugs grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart), and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. ("Clinics" were defined as outpatient care centers and ambulatory service centers.)

As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008-2018 will be released some time this month.

Mr. Foster predicted that the projections will have much less of an upside. "I wouldn't expect the 6.1% to stay that low," he said. "I wouldn't expect the good news to continue."

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

"Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?" asked Richard Foster, CMS chief actuary.

"Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem," he said.

The data indicate that most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963, said Mr. Foster.

In 2006, by contrast, spending on prescription drugs grew by 8.6% (Health Aff. 2009;28:246-61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart), and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill. Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. ("Clinics" were defined as outpatient care centers and ambulatory service centers.)

As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care comprised 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor on the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008-2018 will be released some time this month.

Mr. Foster predicted that the projections will have much less of an upside. "I wouldn't expect the 6.1% to stay that low," he said. "I wouldn't expect the good news to continue."

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over the use of tumor necrosis factor blockers in pregnancy.

Authors of a new review of FDA data advise clinicians against prescribing anti-TNF agents to pregnant women based on their findings that etanercept and infliximab may be responsible for a “seemingly high number” of congenital anomalies. “Clinicians should not prescribe TNF antagonists to women during pregnancy,” wrote the authors of the review.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population. Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies but who has conducted his own surveys on the issue, said in an interview that “the FDA database serves an important role in providing insight into what may be a potential hazard to those receiving these drugs.”

However, he added, “There are biases regarding underreporting, sources of reports, the lack of a denominator, and a grossly underestimated numerator.” Of course, all databases—including the OTIS database—have inherent biases, he cautioned.

“Nonetheless, there is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” said Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005 found with the keywords “congenital anomaly,” “congenital anomalies,” “birth defect,” and “birth defects.” A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers had been taking etanercept at some point during their pregnancy; 19 had been taking infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum.

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include children's defects as part of the VACTERL spectrum means that they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only one was diagnosed with the pattern of associated birth defects within the original study period, according to Dr. Chambers.

Dr. Carter said that he thinks women of child-bearing age taking anti-TNFs should be strongly encouraged to use contraception, as they are with known teratogenic drugs such as Accutane.

Dr. Carter did not declare any conflicts of interest with regard to his study. Dr. Chambers said she did not have any personal conflicts, but that OTIS receives grant funding from nine different pharmaceutical companies, two of which are manufacturers of anti-TNFs. Dr. Cush has served as a consultant or advisor to, or received grant money from, multiple pharmaceutical companies, including the makers of the three anti-TNFs looked at in these studies.

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over the use of tumor necrosis factor blockers in pregnancy.

Authors of a new review of FDA data advise clinicians against prescribing anti-TNF agents to pregnant women based on their findings that etanercept and infliximab may be responsible for a “seemingly high number” of congenital anomalies. “Clinicians should not prescribe TNF antagonists to women during pregnancy,” wrote the authors of the review.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population. Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies but who has conducted his own surveys on the issue, said in an interview that “the FDA database serves an important role in providing insight into what may be a potential hazard to those receiving these drugs.”

However, he added, “There are biases regarding underreporting, sources of reports, the lack of a denominator, and a grossly underestimated numerator.” Of course, all databases—including the OTIS database—have inherent biases, he cautioned.

“Nonetheless, there is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” said Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005 found with the keywords “congenital anomaly,” “congenital anomalies,” “birth defect,” and “birth defects.” A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers had been taking etanercept at some point during their pregnancy; 19 had been taking infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum.

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include children's defects as part of the VACTERL spectrum means that they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only one was diagnosed with the pattern of associated birth defects within the original study period, according to Dr. Chambers.

Dr. Carter said that he thinks women of child-bearing age taking anti-TNFs should be strongly encouraged to use contraception, as they are with known teratogenic drugs such as Accutane.

Dr. Carter did not declare any conflicts of interest with regard to his study. Dr. Chambers said she did not have any personal conflicts, but that OTIS receives grant funding from nine different pharmaceutical companies, two of which are manufacturers of anti-TNFs. Dr. Cush has served as a consultant or advisor to, or received grant money from, multiple pharmaceutical companies, including the makers of the three anti-TNFs looked at in these studies.

Data from a Food and Drug Administration registry suggesting an increase in birth defects among women treated with etanercept and infliximab have rekindled controversy over the use of tumor necrosis factor blockers in pregnancy.

Authors of a new review of FDA data advise clinicians against prescribing anti-TNF agents to pregnant women based on their findings that etanercept and infliximab may be responsible for a “seemingly high number” of congenital anomalies. “Clinicians should not prescribe TNF antagonists to women during pregnancy,” wrote the authors of the review.

However, conflicting preliminary data from an ongoing study by the Organization of Teratology Information Specialists (OTIS) argue that anti-tumor necrosis factor agents are safe for this population. Dr. Christina Chambers, a coinvestigator on the OTIS study, said it was alarmist to recommend avoiding anti-TNF agents in pregnancy, and said that reviews of the FDA adverse events database are “inherently biased.” Based on her group's results, she said, “We're not able to draw any conclusions that suggest that we are seeing any specific pattern of defects, whether major or minor, based on the children that have been evaluated so far.”

Dr. John J. Cush, who is not involved with either of these studies but who has conducted his own surveys on the issue, said in an interview that “the FDA database serves an important role in providing insight into what may be a potential hazard to those receiving these drugs.”

However, he added, “There are biases regarding underreporting, sources of reports, the lack of a denominator, and a grossly underestimated numerator.” Of course, all databases—including the OTIS database—have inherent biases, he cautioned.

“Nonetheless, there is no reason or convincing data to emphatically deny effective anti-TNF therapy to patients who need it to control their disease, either before or during pregnancy,” said Dr. Cush, director of the clinical rheumatology program at Baylor Research Institute in Dallas.

The review of the FDA adverse events database, led by Dr. John D. Carter, involved more than 120,000 adverse events for all entries between 1999 and 2005 found with the keywords “congenital anomaly,” “congenital anomalies,” “birth defect,” and “birth defects.” A total of 41 children with 61 congenital anomalies born to 40 different mothers who were taking a TNF antagonist during pregnancy were recorded (J. Rheumatol. 2008 Dec. 15 [doi:10.3899/jrheum.080545

Overall, 22 of these mothers had been taking etanercept at some point during their pregnancy; 19 had been taking infliximab. “In all 41 cases, the TNF-α antagonist was considered the 'primary suspect' as the cause of the birth defect,” wrote Dr. Carter of the division of rheumatology at the University of South Florida, Tampa.

A total of 34 different types of birth defects were seen, 19 of which were part of the VACTERL spectrum.

In an interview, Dr. Chambers took issue with the VACTERL findings, noting that to include children's defects as part of the VACTERL spectrum means that they must exhibit at least three of the seven defects in the spectrum—not just one. And though the authors emphasize that 24 of 41 children (59%) “had one or more congenital anomalies that are part of VACTERL,” only one was diagnosed with the pattern of associated birth defects within the original study period, according to Dr. Chambers.

Dr. Carter said that he thinks women of child-bearing age taking anti-TNFs should be strongly encouraged to use contraception, as they are with known teratogenic drugs such as Accutane.

Dr. Carter did not declare any conflicts of interest with regard to his study. Dr. Chambers said she did not have any personal conflicts, but that OTIS receives grant funding from nine different pharmaceutical companies, two of which are manufacturers of anti-TNFs. Dr. Cush has served as a consultant or advisor to, or received grant money from, multiple pharmaceutical companies, including the makers of the three anti-TNFs looked at in these studies.

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246–61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill.

Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care was 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor of the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008–2018 will be released sometime in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246–61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill.

Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care was 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor of the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008–2018 will be released sometime in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”

WASHINGTON — Growth in U.S. health care spending slowed in 2007 to 6.1%, the lowest annual growth rate since 1998.

But at $2.2 trillion, or $7,421 per person, health care spending still represented 16.2% of the nation's overall gross domestic product and was an increase from 16% in 2006, according to data published by a group of statisticians and economists from the Center for Medicare and Medicaid Services' Office of the Actuary.

“Do we feel glad that the cost growth overall in 2007 was the lowest in quite some time, since 1998?” asked Richard Foster, CMS chief actuary. “Sure, we're happy about that. But it was still 6.1%. How much did GDP grow that year? How much did your wages increase? We still have this affordability problem,” he said.

The data indicate most of the spending slowdown in 2007 was a result of the markedly lower 4.9% rate of growth in retail prescription drug spending, which amounted to $227.5 billion (10% of total spending) and represented the slowest rate since 1963. In 2006, by contrast, drug spending grew by 8.6% (Health Aff. 2009;28:246–61).

The slowing in retail prescription drug spending was deemed to be a result of three factors: the growth in generic prescription drugs (67% of filled prescriptions in 2007 were generic, up from 63% in 2006); a slower price growth in all drugs (thanks both to the increased use of generics and also the introduction of drug discount programs at national retailers such as Walmart); and increased safety concerns related to numerous black-box warnings issued this year (68 compared with 58 in 2006 and 21 in 2005).

Growth in spending on physician and clinical services remained stable from 2006 to 2007 with a 6.5% increase, accounting for $478.8 billion or 21% of the total health care bill.

Taken separately, the increase was mostly sustained by a growth in spending for clinics, which grew at an average annual rate of 8.5% from 2004 to 2007. (“Clinics” were defined as outpatient care centers and ambulatory service centers.) As a result of cuts in imaging reimbursement and flat or very small payment updates, payments to physicians grew at an average of 6.4% over the same period.

Hospital spending accounted for $696.5 billion or 31% of the total in 2007, with an increase of 7.3%. Nursing home care was 6% of the total, or $131.3 billion, with an increase of 4.8%, up slightly from 4.0% in 2006.

The nation's health care tab in 2007 was split nearly evenly between public and private payers, with 46% coming from the public side—about the same as in 2006, according to Anne Martin, an economist at the CMS Office of the Actuary and a coauthor of the report.

Medicare spending increased 7.2% in 2007, following an 18.5% increase in 2006 that resulted from the implementation of the Part D program that year. Meanwhile, private health insurance premiums grew at a more modest 6.0%.

Lead author and CMS statistician Micah Hartman said that although the current recession did not overlap enough with data reported in this study to have an effect—only 1 month—a set of health spending projections for 2008–2018 will be released sometime in February.

Mr. Foster predicted that the projections will have much less of an upside. “I wouldn't expect the 6.1% to stay that low,” he said. “I wouldn't expect the good news to continue.”