John R. Bell

Congenital hypothyroidism is associated with a smaller caudate nucleus, lower levels of attention, and lower behavior ratings, even in children who started treatment as infants, according to research presented at the annual meeting of the American Thyroid Association.

Santhosh Sekharan, a pharmacology research student at the Hospital for Sick Children, Toronto, analyzed brain scans and test scores of 15 children (aged 10-15 years) with congenital hypothyroidism. The hypothyroidism was caused by thyroid dysgenesis in 11 patients (including 4 with athyrotic dysgenesis and 7 with ectopic thyroid dysgenesis) and hormonal dysgenesis in 4 patients. Treatment for this cohort started at a mean age of 13 days, at a median starting dose of 19.4 mcg/kg of thyroxine (T4). There were 17 control children, for whom prematurity and head injury were exclusion criteria.

The participants and the control group underwent testing for intelligence, memory, and attention, as well as a 1-hour MRI scan, and each mother completed questionnaires assessing her child's behavior.

MR scans revealed that the left and right caudate volumes of the children with congenital hypothyroidism were significantly smaller than were those of the control children. However, among the hypothyroid participants, caudate volume did not vary according to the etiology of the hypothyroidism (athyrotic dysgenesis, ectopic thyroid dysgenesis, or hormonal dysgenesis). Nor did caudate volume differ by age at the inception of treatment, Mr. Sekharan reported.

Greater left-caudate volume predicted higher attention scores, whereas greater right-caudate volume was associated with better scores on parental ratings of behavior.

“Because thyroid hormone is so crucial for early brain development, children with [congenital hypothyroidism] often have severe brain damage and may suffer mental retardation,” he said. “Thankfully, with the advent of newborn screening, these kids can be diagnosed and, more importantly, treated right after birth.”

Congenital hypothyroidism affects 1 in 2,500 newborns in North America and can result from thyroid dysgenesis, hormonal dysgenesis, or abnormal regulation of thyroid hormone synthesis, he noted.

Congenital hypothyroidism is associated with a smaller caudate nucleus, lower levels of attention, and lower behavior ratings, even in children who started treatment as infants, according to research presented at the annual meeting of the American Thyroid Association.

Santhosh Sekharan, a pharmacology research student at the Hospital for Sick Children, Toronto, analyzed brain scans and test scores of 15 children (aged 10-15 years) with congenital hypothyroidism. The hypothyroidism was caused by thyroid dysgenesis in 11 patients (including 4 with athyrotic dysgenesis and 7 with ectopic thyroid dysgenesis) and hormonal dysgenesis in 4 patients. Treatment for this cohort started at a mean age of 13 days, at a median starting dose of 19.4 mcg/kg of thyroxine (T4). There were 17 control children, for whom prematurity and head injury were exclusion criteria.

The participants and the control group underwent testing for intelligence, memory, and attention, as well as a 1-hour MRI scan, and each mother completed questionnaires assessing her child's behavior.

MR scans revealed that the left and right caudate volumes of the children with congenital hypothyroidism were significantly smaller than were those of the control children. However, among the hypothyroid participants, caudate volume did not vary according to the etiology of the hypothyroidism (athyrotic dysgenesis, ectopic thyroid dysgenesis, or hormonal dysgenesis). Nor did caudate volume differ by age at the inception of treatment, Mr. Sekharan reported.

Greater left-caudate volume predicted higher attention scores, whereas greater right-caudate volume was associated with better scores on parental ratings of behavior.

“Because thyroid hormone is so crucial for early brain development, children with [congenital hypothyroidism] often have severe brain damage and may suffer mental retardation,” he said. “Thankfully, with the advent of newborn screening, these kids can be diagnosed and, more importantly, treated right after birth.”

Congenital hypothyroidism affects 1 in 2,500 newborns in North America and can result from thyroid dysgenesis, hormonal dysgenesis, or abnormal regulation of thyroid hormone synthesis, he noted.

Congenital hypothyroidism is associated with a smaller caudate nucleus, lower levels of attention, and lower behavior ratings, even in children who started treatment as infants, according to research presented at the annual meeting of the American Thyroid Association.

Santhosh Sekharan, a pharmacology research student at the Hospital for Sick Children, Toronto, analyzed brain scans and test scores of 15 children (aged 10-15 years) with congenital hypothyroidism. The hypothyroidism was caused by thyroid dysgenesis in 11 patients (including 4 with athyrotic dysgenesis and 7 with ectopic thyroid dysgenesis) and hormonal dysgenesis in 4 patients. Treatment for this cohort started at a mean age of 13 days, at a median starting dose of 19.4 mcg/kg of thyroxine (T4). There were 17 control children, for whom prematurity and head injury were exclusion criteria.

The participants and the control group underwent testing for intelligence, memory, and attention, as well as a 1-hour MRI scan, and each mother completed questionnaires assessing her child's behavior.

MR scans revealed that the left and right caudate volumes of the children with congenital hypothyroidism were significantly smaller than were those of the control children. However, among the hypothyroid participants, caudate volume did not vary according to the etiology of the hypothyroidism (athyrotic dysgenesis, ectopic thyroid dysgenesis, or hormonal dysgenesis). Nor did caudate volume differ by age at the inception of treatment, Mr. Sekharan reported.

Greater left-caudate volume predicted higher attention scores, whereas greater right-caudate volume was associated with better scores on parental ratings of behavior.

“Because thyroid hormone is so crucial for early brain development, children with [congenital hypothyroidism] often have severe brain damage and may suffer mental retardation,” he said. “Thankfully, with the advent of newborn screening, these kids can be diagnosed and, more importantly, treated right after birth.”

Congenital hypothyroidism affects 1 in 2,500 newborns in North America and can result from thyroid dysgenesis, hormonal dysgenesis, or abnormal regulation of thyroid hormone synthesis, he noted.

NEW YORK — Maternal hypothyroidism during pregnancy appears to negatively affect the visual processing centers of the infant brain, according to research presented at the annual meeting of the American Thyroid Association.

Dr. Joanne Rovet of the Hospital for Sick Children, Toronto, reported findings from a study of 36 children of women diagnosed with hypothyroidism before or during pregnancy who were currently being treated with levothyroxine. Of the mothers, 78% were diagnosed before pregnancy and 22% during pregnancy. Infants were a mean age of 8 months when tested. In all, 55% of the infants were male; all were tested by an ophthalmologist to ensure they had normal refraction. A group of 26 control infants (mean age 7 months; 54% male) were born to mothers whose euthyroid status was confirmed at the time of testing and during follow-up.

Thyroid stimulating hormone (TSH) levels were not taken from all mothers in all trimesters. However, mean TSH levels for the study mothers were 12.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester. In the first trimester, TSH ranged from 0.01 to 100, and 16% of mothers had low TSH in the first trimester.

Mean maternal levels of free thyroxin (free T4) were 13.4, 13.9, and 15.9 pmol/L in each successive trimester. Overall, 20% of women had low thyroid hormone levels in the first trimester, as did 18% in the second trimester.

Among women whose data were available, maternal TSH levels were 13.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester.

Visual acuity and contrast sensitivity were tested via application of visual stimuli, with brain activity measured at 6 Hz, 10 Hz, and 15 Hz using the Power Diva system. This system measures the neuroelectric signal in relation to the amount of contrast to produce a visual evoked potential (VEP).

Although there was no difference in visual acuity between the study infants and the control infants, there was reduced contrast sensitivity among the study infants, primarily in those whose mothers had low TSH levels. In particular, offspring of mothers who had low TSH in the second half of pregnancy had significantly lower contrast sensitivity.

In addition, free T4 was not linked with reduced contrast sensitivity in the first half of pregnancy, when levels of free T4 were relatively uniform; in the second half, however, children of the mothers who now had lower free T4 levels had significantly reduced contrast sensitivity.

Thus, although maternal hypothyroidism was not seen to affect neonatal visual acuity, it was linked with reduced contrast sensitivity, Dr. Rovet concluded. This might be a factor in the association found in previous studies between high maternal TSH and offspring reading disability. She noted that the effect is specific to the magno pathway.

Dr. Rovet and colleagues also found visual-spatial and visual-motor disabilities in offspring of women with low free T4 levels. Children of mothers with a free T4 level below 11.2 pmol/L in the first trimester or in the third trimester had significantly poorer visual-spatial and visual-motor abilities, she said.

This research echoes the findings of a study of 42 preterm infants by Dr. Rovet and colleagues that was presented as a poster at the meeting. In that study, early preterm infants had both lower TSH levels and longer VEP measures than did infants born less prematurely.

NEW YORK — Maternal hypothyroidism during pregnancy appears to negatively affect the visual processing centers of the infant brain, according to research presented at the annual meeting of the American Thyroid Association.

Dr. Joanne Rovet of the Hospital for Sick Children, Toronto, reported findings from a study of 36 children of women diagnosed with hypothyroidism before or during pregnancy who were currently being treated with levothyroxine. Of the mothers, 78% were diagnosed before pregnancy and 22% during pregnancy. Infants were a mean age of 8 months when tested. In all, 55% of the infants were male; all were tested by an ophthalmologist to ensure they had normal refraction. A group of 26 control infants (mean age 7 months; 54% male) were born to mothers whose euthyroid status was confirmed at the time of testing and during follow-up.

Thyroid stimulating hormone (TSH) levels were not taken from all mothers in all trimesters. However, mean TSH levels for the study mothers were 12.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester. In the first trimester, TSH ranged from 0.01 to 100, and 16% of mothers had low TSH in the first trimester.

Mean maternal levels of free thyroxin (free T4) were 13.4, 13.9, and 15.9 pmol/L in each successive trimester. Overall, 20% of women had low thyroid hormone levels in the first trimester, as did 18% in the second trimester.

Among women whose data were available, maternal TSH levels were 13.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester.

Visual acuity and contrast sensitivity were tested via application of visual stimuli, with brain activity measured at 6 Hz, 10 Hz, and 15 Hz using the Power Diva system. This system measures the neuroelectric signal in relation to the amount of contrast to produce a visual evoked potential (VEP).

Although there was no difference in visual acuity between the study infants and the control infants, there was reduced contrast sensitivity among the study infants, primarily in those whose mothers had low TSH levels. In particular, offspring of mothers who had low TSH in the second half of pregnancy had significantly lower contrast sensitivity.

In addition, free T4 was not linked with reduced contrast sensitivity in the first half of pregnancy, when levels of free T4 were relatively uniform; in the second half, however, children of the mothers who now had lower free T4 levels had significantly reduced contrast sensitivity.

Thus, although maternal hypothyroidism was not seen to affect neonatal visual acuity, it was linked with reduced contrast sensitivity, Dr. Rovet concluded. This might be a factor in the association found in previous studies between high maternal TSH and offspring reading disability. She noted that the effect is specific to the magno pathway.

Dr. Rovet and colleagues also found visual-spatial and visual-motor disabilities in offspring of women with low free T4 levels. Children of mothers with a free T4 level below 11.2 pmol/L in the first trimester or in the third trimester had significantly poorer visual-spatial and visual-motor abilities, she said.

This research echoes the findings of a study of 42 preterm infants by Dr. Rovet and colleagues that was presented as a poster at the meeting. In that study, early preterm infants had both lower TSH levels and longer VEP measures than did infants born less prematurely.

NEW YORK — Maternal hypothyroidism during pregnancy appears to negatively affect the visual processing centers of the infant brain, according to research presented at the annual meeting of the American Thyroid Association.

Dr. Joanne Rovet of the Hospital for Sick Children, Toronto, reported findings from a study of 36 children of women diagnosed with hypothyroidism before or during pregnancy who were currently being treated with levothyroxine. Of the mothers, 78% were diagnosed before pregnancy and 22% during pregnancy. Infants were a mean age of 8 months when tested. In all, 55% of the infants were male; all were tested by an ophthalmologist to ensure they had normal refraction. A group of 26 control infants (mean age 7 months; 54% male) were born to mothers whose euthyroid status was confirmed at the time of testing and during follow-up.

Thyroid stimulating hormone (TSH) levels were not taken from all mothers in all trimesters. However, mean TSH levels for the study mothers were 12.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester. In the first trimester, TSH ranged from 0.01 to 100, and 16% of mothers had low TSH in the first trimester.

Mean maternal levels of free thyroxin (free T4) were 13.4, 13.9, and 15.9 pmol/L in each successive trimester. Overall, 20% of women had low thyroid hormone levels in the first trimester, as did 18% in the second trimester.

Among women whose data were available, maternal TSH levels were 13.07 mIU/L in the first trimester, 2.87 mIU/L in the second trimester, and 1.92 mIU/L in the third trimester.

Visual acuity and contrast sensitivity were tested via application of visual stimuli, with brain activity measured at 6 Hz, 10 Hz, and 15 Hz using the Power Diva system. This system measures the neuroelectric signal in relation to the amount of contrast to produce a visual evoked potential (VEP).

Although there was no difference in visual acuity between the study infants and the control infants, there was reduced contrast sensitivity among the study infants, primarily in those whose mothers had low TSH levels. In particular, offspring of mothers who had low TSH in the second half of pregnancy had significantly lower contrast sensitivity.

In addition, free T4 was not linked with reduced contrast sensitivity in the first half of pregnancy, when levels of free T4 were relatively uniform; in the second half, however, children of the mothers who now had lower free T4 levels had significantly reduced contrast sensitivity.

Thus, although maternal hypothyroidism was not seen to affect neonatal visual acuity, it was linked with reduced contrast sensitivity, Dr. Rovet concluded. This might be a factor in the association found in previous studies between high maternal TSH and offspring reading disability. She noted that the effect is specific to the magno pathway.

Dr. Rovet and colleagues also found visual-spatial and visual-motor disabilities in offspring of women with low free T4 levels. Children of mothers with a free T4 level below 11.2 pmol/L in the first trimester or in the third trimester had significantly poorer visual-spatial and visual-motor abilities, she said.

This research echoes the findings of a study of 42 preterm infants by Dr. Rovet and colleagues that was presented as a poster at the meeting. In that study, early preterm infants had both lower TSH levels and longer VEP measures than did infants born less prematurely.

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the payments will help offset the higher cost of private insurance.

To encourage preventive care, participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.”

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, Dr. Krotowski added.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, Dr. Racine said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat,” he said. Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1.

“We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

Opportunity NYC, which grew out of Mayor Bloomberg's antipoverty Center for Economic Opportunity, is not the first conditional cash transfer program. The government of Mexico offered the first such program to its citizens in 1997, and nearly one-fourth of the population is enrolled, according to a recent New York Times report. Approximately 20 countries now have such programs in place.

Dr. Mark Krotowski, who practices in the Canarsie area of Brooklyn, nearthe target neighborhood of Brownsville, was sanguine about the program's potential. John R. Bell/Elsevier Global Medical News

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the payments will help offset the higher cost of private insurance.

To encourage preventive care, participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.”

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, Dr. Krotowski added.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, Dr. Racine said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat,” he said. Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1.

“We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

Opportunity NYC, which grew out of Mayor Bloomberg's antipoverty Center for Economic Opportunity, is not the first conditional cash transfer program. The government of Mexico offered the first such program to its citizens in 1997, and nearly one-fourth of the population is enrolled, according to a recent New York Times report. Approximately 20 countries now have such programs in place.

Dr. Mark Krotowski, who practices in the Canarsie area of Brooklyn, nearthe target neighborhood of Brownsville, was sanguine about the program's potential. John R. Bell/Elsevier Global Medical News

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the payments will help offset the higher cost of private insurance.

To encourage preventive care, participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.”

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, Dr. Krotowski added.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20-$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, Dr. Racine said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat,” he said. Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1.

“We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the fourth, seventh, or ninth grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

Opportunity NYC, which grew out of Mayor Bloomberg's antipoverty Center for Economic Opportunity, is not the first conditional cash transfer program. The government of Mexico offered the first such program to its citizens in 1997, and nearly one-fourth of the population is enrolled, according to a recent New York Times report. Approximately 20 countries now have such programs in place.

Dr. Mark Krotowski, who practices in the Canarsie area of Brooklyn, nearthe target neighborhood of Brownsville, was sanguine about the program's potential. John R. Bell/Elsevier Global Medical News

WASHINGTON — Antioxidant supplementation was effective in curbing pain in patients with chronic pancreatitis in a double-blinded, randomized controlled trial.

Measures of pain and oxidative stress were significantly lower in patients who took a daily antioxidant supplement for 6 months, compared with those who took a placebo pill, investigators reported at the annual Digestive Disease Week.

“It's very difficult to treat pain, so antioxidants are a simple treatment and a dietary constituent, and if it can reduce the pain, this is of immense benefit to these patients,” study investigator Dr. Payal Bhardwaj of the All India Institute of Medical Sciences, New Delhi, said at a press conference during the meeting.

About 90% of patients who have chronic pancreatitis have abdominal pain, conventionally treated by surgery, nerve blocks, or endoscopic treatment. “These three procedures are very invasive,” she said. “What we have seen is a totally noninvasive dietary modulation.”

The study included 127 consecutive patients (mean age 31 years) with chronic pancreatitis and abdominal pain who were randomly assigned to receive a daily antioxidant supplement (71 patients) or placebo (56 patients) for 6 months.

The supplement contained 600 mcg of selenium, 0.54 g of vitamin C, 9,000 IU of beta-carotene, 270 IU of vitamin E, and 2 g of methionine.

Pain relief was the primary outcome. Regression analysis at 6 months showed significantly decreased measures of pain in the supplement compared with the placebo group: mean number of painful days monthly (1.7 vs. 3.4), mean number of oral analgesics taken monthly (4.4 vs. 10.5), and patients who reported that they were pain free (33% vs. 13%).

Secondary outcomes included levels of two markers of oxidative stress, both of which were significantly lower in the supplement group vs. placebo after 6 months: thiobarbituric acid reactive substances (3.6 vs. 5.4 nmol/mL) and serum superoxide dismutase (1.9 vs. 3.5 U/mL).

Dr. Bhardwaj noted that prior studies have also shown a benefit from antioxidants but that they were hindered by small sample sizes, shorter follow-up, subjective pain measures, or a crossover design.

Dr. Bhardwaj reported no potential conflicts of interest.

WASHINGTON — Antioxidant supplementation was effective in curbing pain in patients with chronic pancreatitis in a double-blinded, randomized controlled trial.

Measures of pain and oxidative stress were significantly lower in patients who took a daily antioxidant supplement for 6 months, compared with those who took a placebo pill, investigators reported at the annual Digestive Disease Week.

“It's very difficult to treat pain, so antioxidants are a simple treatment and a dietary constituent, and if it can reduce the pain, this is of immense benefit to these patients,” study investigator Dr. Payal Bhardwaj of the All India Institute of Medical Sciences, New Delhi, said at a press conference during the meeting.

About 90% of patients who have chronic pancreatitis have abdominal pain, conventionally treated by surgery, nerve blocks, or endoscopic treatment. “These three procedures are very invasive,” she said. “What we have seen is a totally noninvasive dietary modulation.”

The study included 127 consecutive patients (mean age 31 years) with chronic pancreatitis and abdominal pain who were randomly assigned to receive a daily antioxidant supplement (71 patients) or placebo (56 patients) for 6 months.

The supplement contained 600 mcg of selenium, 0.54 g of vitamin C, 9,000 IU of beta-carotene, 270 IU of vitamin E, and 2 g of methionine.

Pain relief was the primary outcome. Regression analysis at 6 months showed significantly decreased measures of pain in the supplement compared with the placebo group: mean number of painful days monthly (1.7 vs. 3.4), mean number of oral analgesics taken monthly (4.4 vs. 10.5), and patients who reported that they were pain free (33% vs. 13%).

Secondary outcomes included levels of two markers of oxidative stress, both of which were significantly lower in the supplement group vs. placebo after 6 months: thiobarbituric acid reactive substances (3.6 vs. 5.4 nmol/mL) and serum superoxide dismutase (1.9 vs. 3.5 U/mL).

Dr. Bhardwaj noted that prior studies have also shown a benefit from antioxidants but that they were hindered by small sample sizes, shorter follow-up, subjective pain measures, or a crossover design.

Dr. Bhardwaj reported no potential conflicts of interest.

WASHINGTON — Antioxidant supplementation was effective in curbing pain in patients with chronic pancreatitis in a double-blinded, randomized controlled trial.

Measures of pain and oxidative stress were significantly lower in patients who took a daily antioxidant supplement for 6 months, compared with those who took a placebo pill, investigators reported at the annual Digestive Disease Week.

“It's very difficult to treat pain, so antioxidants are a simple treatment and a dietary constituent, and if it can reduce the pain, this is of immense benefit to these patients,” study investigator Dr. Payal Bhardwaj of the All India Institute of Medical Sciences, New Delhi, said at a press conference during the meeting.

About 90% of patients who have chronic pancreatitis have abdominal pain, conventionally treated by surgery, nerve blocks, or endoscopic treatment. “These three procedures are very invasive,” she said. “What we have seen is a totally noninvasive dietary modulation.”

The study included 127 consecutive patients (mean age 31 years) with chronic pancreatitis and abdominal pain who were randomly assigned to receive a daily antioxidant supplement (71 patients) or placebo (56 patients) for 6 months.

The supplement contained 600 mcg of selenium, 0.54 g of vitamin C, 9,000 IU of beta-carotene, 270 IU of vitamin E, and 2 g of methionine.

Pain relief was the primary outcome. Regression analysis at 6 months showed significantly decreased measures of pain in the supplement compared with the placebo group: mean number of painful days monthly (1.7 vs. 3.4), mean number of oral analgesics taken monthly (4.4 vs. 10.5), and patients who reported that they were pain free (33% vs. 13%).

Secondary outcomes included levels of two markers of oxidative stress, both of which were significantly lower in the supplement group vs. placebo after 6 months: thiobarbituric acid reactive substances (3.6 vs. 5.4 nmol/mL) and serum superoxide dismutase (1.9 vs. 3.5 U/mL).

Dr. Bhardwaj noted that prior studies have also shown a benefit from antioxidants but that they were hindered by small sample sizes, shorter follow-up, subjective pain measures, or a crossover design.

Dr. Bhardwaj reported no potential conflicts of interest.

WASHINGTON — Positron emission tomography findings significantly altered the course of disease management in more than one-third of a group of patients with potentially curable esophageal and gastroesophageal cancers, according to findings from a prospective, multicenter, single-arm study presented at the annual meeting of the Society of Nuclear Medicine.

Dr. Barry E. Chatterton of Royal Adelaide Hospital, South Australia, and his colleagues reported that PET influenced the management of 38% of 129 patients with confirmed esophageal cancers (squamous cell carcinoma or adenocarcinoma) whose disease had already been diagnosed with conventional imaging (barium study, endoscopy, or CT).

Patients were referred from five hospitals, and all had undergone endoscopy and biopsy, with proven histology. Most patients were male (104 patients), and the mean age was 67 years (range 36–87). Most tumors were in the distal esophagus.

To participate in the study, patients were required to have documented esophageal cancer and no unequivocal distant metastatic disease seen with other imaging modalities. Patients who were pregnant or had uncontrolled diabetes were excluded.

Referring physicians were asked for their management plans before and after receiving the PET results and were asked whether the treatment goal was cure or palliation. Impact of the PET results on disease management was classified as none, low, medium, or high.

The investigators found that PET revealed 148 additional lesions in 53 (41%) of the 129 patients. For an additional 22% of the total population, disease was upstaged from M0 to M1.

PET also detected local metastasis in 70% of patients and distant metastasis in 44% of patients, compared with 67% and 33%, respectively, in a subset of 20 patients who also underwent endoscopic ultrasound.

The impact on disease management was considered medium to high in 38% of cases. Curative intent was changed to palliative intent in 20% based on PET results, and from palliative to curative in 3%.

Surprisingly, Dr. Chatterton said, there was no difference in progression-free survival between patients with high and low standardized uptake values.

Dr. Chatterton cautioned that these results do not in his view warrant replacement of CT or ultrasound by PET, “because a lot of the patients with widespread disease were excluded by diagnostic CT beforehand. I think that with the relative costs of diagnostic CT and PET-CT in Australia … most patients will continue to have diagnostic CT with contrast before they come to [get] PET, because at least half of them will be found to have inoperable disease. So I don't think it will be regarded as the initial imaging study after biopsy.”

The study was funded by the Australian government as part of the Australian PET Data Collection Project.

Shown are FDG-PET maximum intensity projection (left) and orthogonal coronal, transverse, and sagittal PET/CT images of a patient with a primary esophageal cancer, with spread to the liver and lumbar vertebra. Images courtesy Dr. Barry E. Chatterton

PET influenced the management of 38% of 129 patients with confirmed esophageal cancers. DR. CHATTERTON

WASHINGTON — Positron emission tomography findings significantly altered the course of disease management in more than one-third of a group of patients with potentially curable esophageal and gastroesophageal cancers, according to findings from a prospective, multicenter, single-arm study presented at the annual meeting of the Society of Nuclear Medicine.

Dr. Barry E. Chatterton of Royal Adelaide Hospital, South Australia, and his colleagues reported that PET influenced the management of 38% of 129 patients with confirmed esophageal cancers (squamous cell carcinoma or adenocarcinoma) whose disease had already been diagnosed with conventional imaging (barium study, endoscopy, or CT).

Patients were referred from five hospitals, and all had undergone endoscopy and biopsy, with proven histology. Most patients were male (104 patients), and the mean age was 67 years (range 36–87). Most tumors were in the distal esophagus.

To participate in the study, patients were required to have documented esophageal cancer and no unequivocal distant metastatic disease seen with other imaging modalities. Patients who were pregnant or had uncontrolled diabetes were excluded.

Referring physicians were asked for their management plans before and after receiving the PET results and were asked whether the treatment goal was cure or palliation. Impact of the PET results on disease management was classified as none, low, medium, or high.

The investigators found that PET revealed 148 additional lesions in 53 (41%) of the 129 patients. For an additional 22% of the total population, disease was upstaged from M0 to M1.

PET also detected local metastasis in 70% of patients and distant metastasis in 44% of patients, compared with 67% and 33%, respectively, in a subset of 20 patients who also underwent endoscopic ultrasound.

The impact on disease management was considered medium to high in 38% of cases. Curative intent was changed to palliative intent in 20% based on PET results, and from palliative to curative in 3%.

Surprisingly, Dr. Chatterton said, there was no difference in progression-free survival between patients with high and low standardized uptake values.

Dr. Chatterton cautioned that these results do not in his view warrant replacement of CT or ultrasound by PET, “because a lot of the patients with widespread disease were excluded by diagnostic CT beforehand. I think that with the relative costs of diagnostic CT and PET-CT in Australia … most patients will continue to have diagnostic CT with contrast before they come to [get] PET, because at least half of them will be found to have inoperable disease. So I don't think it will be regarded as the initial imaging study after biopsy.”

The study was funded by the Australian government as part of the Australian PET Data Collection Project.

Shown are FDG-PET maximum intensity projection (left) and orthogonal coronal, transverse, and sagittal PET/CT images of a patient with a primary esophageal cancer, with spread to the liver and lumbar vertebra. Images courtesy Dr. Barry E. Chatterton

PET influenced the management of 38% of 129 patients with confirmed esophageal cancers. DR. CHATTERTON

WASHINGTON — Positron emission tomography findings significantly altered the course of disease management in more than one-third of a group of patients with potentially curable esophageal and gastroesophageal cancers, according to findings from a prospective, multicenter, single-arm study presented at the annual meeting of the Society of Nuclear Medicine.

Dr. Barry E. Chatterton of Royal Adelaide Hospital, South Australia, and his colleagues reported that PET influenced the management of 38% of 129 patients with confirmed esophageal cancers (squamous cell carcinoma or adenocarcinoma) whose disease had already been diagnosed with conventional imaging (barium study, endoscopy, or CT).

Patients were referred from five hospitals, and all had undergone endoscopy and biopsy, with proven histology. Most patients were male (104 patients), and the mean age was 67 years (range 36–87). Most tumors were in the distal esophagus.

To participate in the study, patients were required to have documented esophageal cancer and no unequivocal distant metastatic disease seen with other imaging modalities. Patients who were pregnant or had uncontrolled diabetes were excluded.

Referring physicians were asked for their management plans before and after receiving the PET results and were asked whether the treatment goal was cure or palliation. Impact of the PET results on disease management was classified as none, low, medium, or high.

The investigators found that PET revealed 148 additional lesions in 53 (41%) of the 129 patients. For an additional 22% of the total population, disease was upstaged from M0 to M1.

PET also detected local metastasis in 70% of patients and distant metastasis in 44% of patients, compared with 67% and 33%, respectively, in a subset of 20 patients who also underwent endoscopic ultrasound.

The impact on disease management was considered medium to high in 38% of cases. Curative intent was changed to palliative intent in 20% based on PET results, and from palliative to curative in 3%.

Surprisingly, Dr. Chatterton said, there was no difference in progression-free survival between patients with high and low standardized uptake values.

Dr. Chatterton cautioned that these results do not in his view warrant replacement of CT or ultrasound by PET, “because a lot of the patients with widespread disease were excluded by diagnostic CT beforehand. I think that with the relative costs of diagnostic CT and PET-CT in Australia … most patients will continue to have diagnostic CT with contrast before they come to [get] PET, because at least half of them will be found to have inoperable disease. So I don't think it will be regarded as the initial imaging study after biopsy.”

The study was funded by the Australian government as part of the Australian PET Data Collection Project.

Shown are FDG-PET maximum intensity projection (left) and orthogonal coronal, transverse, and sagittal PET/CT images of a patient with a primary esophageal cancer, with spread to the liver and lumbar vertebra. Images courtesy Dr. Barry E. Chatterton

PET influenced the management of 38% of 129 patients with confirmed esophageal cancers. DR. CHATTERTON

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20–$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.”

Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the 4th, 7th, or 9th grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550 per group) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

The AAP is delighted with any sort of rethinking of how we can improve the health status of children. DR. RACINE

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20–$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.”

Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the 4th, 7th, or 9th grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550 per group) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

The AAP is delighted with any sort of rethinking of how we can improve the health status of children. DR. RACINE

NEW YORK — A new program in New York City that pays low-income families for obtaining preventive medical care and for maintaining health insurance is garnering its share of praise and skepticism among physicians who practice there.

Under the pilot program, Opportunity NYC, which began in September, families will receive $20 per parent or guardian per month via wire transfer for maintaining public health insurance or $50 for maintaining private health insurance, and the same amount for maintaining insurance for all children in the family. Funding is being provided through corporations as well as from Mayor Michael Bloomberg, who conceived the idea.

The program also pays enrolled parents when their children attend school regularly, get a library card, or do well on tests. Other payments reward preventive dental care and continued parental employment.

Although the payment amount is relatively low, the hope is that it will serve as an incentive for families who already have public health insurance to actively maintain that coverage by making sure it is not disrupted when the time comes to recertify their eligibility, Linda I. Gibbs, New York's deputy mayor for health and human services, said in an interview. For the small number of participants who don't qualify for public health insurance because they are employed, the idea will help them offset the higher cost of private insurance.

The encouragement of preventive care is another component. Participants are paid $200 for each annual preventive visit to any physician in their plan. Physicians are required to provide age-appropriate preventive care. “We know that many families, even with public health insurance, are not going to those annual preventive visits.” And even when they do go, “doctors are not always providing all of the [preventive care] that the child or the adult should be getting during that visit.” So the program is building in an attempt to achieve quality standards.

Childhood vaccinations would fall under required preventive care services, she said. When the preventive visit indicates a follow-up visit or treatment is necessary for any family member, the family receives a $100 payment for that visit as well.

Dr. Mark Krotowski, who practices family medicine in the Canarsie area of Brooklyn, near the target neighborhood of Brownsville, was sanguine about the program's potential. “It's a good thing. … With the cash incentives, it'll certainly encourage the parents to bring in the kids,” said Dr. Krotowski, who is chairman of family medicine at the borough's Brookdale Hospital.

Dr. Krotowski noted that the incentives may help primary care physicians combat childhood obesity, which he says is “probably the biggest medical challenge in New York City. If we can get the kids early, we can refer them to specialists who deal with obesity and try to take care of them.”

The state of New York already has a fairly efficient system for providing medical care to its low-income residents via the HMO Medicaid or HMO Child Health Plus programs, added Dr. Krotowski, who is also vice chair of the New York state chapter of the American Academy of Family Physicians.

Dr. Linda Prine, a family physician at Sidney Hillman Health Center in New York, said that she is underwhelmed by the program's ability to have any real impact. “This program is a drop in the bucket and does not begin to address the problem of lack of affordable health care for the uninsured. People at this level of poverty cannot afford the monthly premiums to buy health insurance, even with a rebate of $20–$50,” said Dr. Prine, chair of the Public Health Commission of the New York State Academy of Family Physicians.

The cost of the program, which so far is operating solely from private funding, makes its long-term viability uncertain, according to Dr. Andrew D. Racine, vice president of the American Academy of Pediatrics chapter that covers the Bronx, Manhattan, and Staten Island.

“Obviously, the American Academy of Pediatrics is delighted with any sort of rethinking of how we can improve the health status of children,” but the opportunity costs have to be addressed, he said in an interview.

“If you decide you're going to spend X amount of money to induce people to maintain health insurance, there are a lot of ways to skin that cat.”

Direct cash for medicine is one option; another is to extend Medicaid enrollment to automatically last for 2 years instead of 1. “We know that there are things that we could be doing to maintain health insurance in children that we're not already doing,” said Dr. Racine, who also is director of general pediatrics at the Children's Hospital at Montefiore, in New York.

That said, Dr. Racine expressed full support for the aspects of the program that encourage preventive care. “The principle of actually using cash incentives to get people to do things is great. It's sort of the opposite of taxing. You tax things that you don't want people to do, and this is sort of an inverse tax,” he said.

Currently, 5,100 families are being recruited via the schools' free-lunch program in six city neighborhoods in which the poverty rates exceed 40%. Candidates must have children in the 4th, 7th, or 9th grades and must be documented legal residents or U.S. citizens.

An equal number of families (2,550 per group) will be randomly assigned to a study group and to a control group in order to study the program's efficacy, Ms. Gibbs explained.

Because many low-income families do not have bank accounts, the mayor's office recruited four banks and four credit unions to provide free checking accounts for program participants.

The AAP is delighted with any sort of rethinking of how we can improve the health status of children. DR. RACINE

WASHINGTON — Children and adolescents with functional abdominal pain or irritable bowel syndrome who were treated with hypnotherapy were cured of their illness in significantly greater numbers than were children given standard medical treatment in a randomized, controlled trial presented at the annual Digestive Disease Week.

Dr. Arine M. Vlieger of St. Antonius Hospital, Nieuwegein, the Netherlands and her colleagues randomly assigned 53 patients (mean age 13 years) with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) to either hypnotherapy or standard medical therapy (SMT).

Hypnotherapy consisted of six half-hour sessions based on the Manchester protocol of gut-directed hypnotherapy, conducted over 3 months (27 patients). The hypnotherapy sessions started with relaxation and abdominal breathing exercises. Other sessions dealt with control of gut function, pain control, and thinking relaxing thoughts. The children in this arm were asked to practice the techniques twice daily. SMT comprised pain medication and avoidance of pain triggers, plus six half-hour sessions of supportive therapy (25 patients); 1 patient did not complete therapy.

Three-fourths of the patients were female, and the mean duration of the abdominal complaints was 3.4 years.

The investigators found that immediately after therapy, 59% of patients given hypnotherapy were cured (defined as having a greater than 80% improvement in pain scores), compared with 12% of patients given SMT. At 1 year, the difference remained, with 85% and 25% classified as cured, respectively.

The proportions of patients who reported no effect of treatment (defined as less than 30% improvement in pain scores) were 56% of the SMT group and 15% of the hypnosis group after therapy; at 1 year, the figures were 46% for SMT patients and 4% for those given hypnotherapy.

Hypnotherapy has been used successfully in adults with IBS, and “the quality of life in these children [pretreatment] is comparable to [that of] those with Crohn's disease or ulcerative colitis,” Dr. Vlieger said at a press conference.

WASHINGTON — Children and adolescents with functional abdominal pain or irritable bowel syndrome who were treated with hypnotherapy were cured of their illness in significantly greater numbers than were children given standard medical treatment in a randomized, controlled trial presented at the annual Digestive Disease Week.

Dr. Arine M. Vlieger of St. Antonius Hospital, Nieuwegein, the Netherlands and her colleagues randomly assigned 53 patients (mean age 13 years) with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) to either hypnotherapy or standard medical therapy (SMT).

Hypnotherapy consisted of six half-hour sessions based on the Manchester protocol of gut-directed hypnotherapy, conducted over 3 months (27 patients). The hypnotherapy sessions started with relaxation and abdominal breathing exercises. Other sessions dealt with control of gut function, pain control, and thinking relaxing thoughts. The children in this arm were asked to practice the techniques twice daily. SMT comprised pain medication and avoidance of pain triggers, plus six half-hour sessions of supportive therapy (25 patients); 1 patient did not complete therapy.

Three-fourths of the patients were female, and the mean duration of the abdominal complaints was 3.4 years.

The investigators found that immediately after therapy, 59% of patients given hypnotherapy were cured (defined as having a greater than 80% improvement in pain scores), compared with 12% of patients given SMT. At 1 year, the difference remained, with 85% and 25% classified as cured, respectively.

The proportions of patients who reported no effect of treatment (defined as less than 30% improvement in pain scores) were 56% of the SMT group and 15% of the hypnosis group after therapy; at 1 year, the figures were 46% for SMT patients and 4% for those given hypnotherapy.

Hypnotherapy has been used successfully in adults with IBS, and “the quality of life in these children [pretreatment] is comparable to [that of] those with Crohn's disease or ulcerative colitis,” Dr. Vlieger said at a press conference.

WASHINGTON — Children and adolescents with functional abdominal pain or irritable bowel syndrome who were treated with hypnotherapy were cured of their illness in significantly greater numbers than were children given standard medical treatment in a randomized, controlled trial presented at the annual Digestive Disease Week.

Dr. Arine M. Vlieger of St. Antonius Hospital, Nieuwegein, the Netherlands and her colleagues randomly assigned 53 patients (mean age 13 years) with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) to either hypnotherapy or standard medical therapy (SMT).

Hypnotherapy consisted of six half-hour sessions based on the Manchester protocol of gut-directed hypnotherapy, conducted over 3 months (27 patients). The hypnotherapy sessions started with relaxation and abdominal breathing exercises. Other sessions dealt with control of gut function, pain control, and thinking relaxing thoughts. The children in this arm were asked to practice the techniques twice daily. SMT comprised pain medication and avoidance of pain triggers, plus six half-hour sessions of supportive therapy (25 patients); 1 patient did not complete therapy.

Three-fourths of the patients were female, and the mean duration of the abdominal complaints was 3.4 years.

The investigators found that immediately after therapy, 59% of patients given hypnotherapy were cured (defined as having a greater than 80% improvement in pain scores), compared with 12% of patients given SMT. At 1 year, the difference remained, with 85% and 25% classified as cured, respectively.

The proportions of patients who reported no effect of treatment (defined as less than 30% improvement in pain scores) were 56% of the SMT group and 15% of the hypnosis group after therapy; at 1 year, the figures were 46% for SMT patients and 4% for those given hypnotherapy.

Hypnotherapy has been used successfully in adults with IBS, and “the quality of life in these children [pretreatment] is comparable to [that of] those with Crohn's disease or ulcerative colitis,” Dr. Vlieger said at a press conference.

NEW YORK — Long-term use of tacrolimus ointment was effective in managing atopic dermatitis and preventing disease flares in a group of adults and children, Dr. Alan B. Fleischer said in a poster presented at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and his colleagues enrolled 383 patients with at least moderate atopic dermatitis in a study sponsored by Astellas Pharma Inc., manufacturer of tacrolimus (Protopic).

Patients first went through a 16-week, randomized, double-blinded disease-stabilization phase. In the first 4 days, 190 patients received twice-daily doses of tacrolimus ointment (0.1% for adult patients and 0.03% for pediatric patients) and 193 patients received a corticosteroid twice a day. For the remaining portion of the stabilization phase, they received twice-daily open-label tacrolimus ointment until clear or almost clear of disease for at least 2 weeks, up to 16 weeks.

For the maintenance phase of the trial, patients with clear or nearly clear skin were randomly assigned to either tacrolimus ointment (125 patients) or a placebo vehicle (72 patients) in a double-blind fashion. Both were applied three times a week for up to 40 weeks. Patients who relapsed were given up to 8 weeks of open-label tacrolimus twice a day until clear or almost clear of their atopic dermatitis, at which point they returned to the study regimen. Patients whose disease did not achieve this response dropped out of the study.

Use of corticosteroids was permitted only in the initial portion of the stabilization phase.

At the end of 40 weeks, patients receiving tacrolimus ointment had 177 flare-free treatment days (the primary end point) versus 134 for those in the placebo group—a difference that reached statistical significance. Moreover, the time to first relapse was 169 days for patients who received tacrolimus and 43 days in the placebo group, and tacrolimus was associated with fewer total relapse days (45.5 days) than the placebo vehicle (64.5 days). Among patients in the tacrolimus group, 6% experienced disease relapse, compared with 17% in the vehicle group.

Adverse events primarily involved itching and burning and occurred predominantly in the stabilization phase of the study. The only significant difference in adverse events was seen at day 4 of the stabilization phase, with 18% (33 patients) in the tacrolimus group reporting any adverse event versus 9% (17 patients) in the corticosteroid group, Dr. Fleischer said.

Although tacrolimus was effective in this study population, efficacy might vary in other groups, given the widely divergent presentation possible with atopic dermatitis.

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Long-term use of tacrolimus ointment was effective in managing atopic dermatitis and preventing disease flares in a group of adults and children, Dr. Alan B. Fleischer said in a poster presented at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and his colleagues enrolled 383 patients with at least moderate atopic dermatitis in a study sponsored by Astellas Pharma Inc., manufacturer of tacrolimus (Protopic).

Patients first went through a 16-week, randomized, double-blinded disease-stabilization phase. In the first 4 days, 190 patients received twice-daily doses of tacrolimus ointment (0.1% for adult patients and 0.03% for pediatric patients) and 193 patients received a corticosteroid twice a day. For the remaining portion of the stabilization phase, they received twice-daily open-label tacrolimus ointment until clear or almost clear of disease for at least 2 weeks, up to 16 weeks.

For the maintenance phase of the trial, patients with clear or nearly clear skin were randomly assigned to either tacrolimus ointment (125 patients) or a placebo vehicle (72 patients) in a double-blind fashion. Both were applied three times a week for up to 40 weeks. Patients who relapsed were given up to 8 weeks of open-label tacrolimus twice a day until clear or almost clear of their atopic dermatitis, at which point they returned to the study regimen. Patients whose disease did not achieve this response dropped out of the study.

Use of corticosteroids was permitted only in the initial portion of the stabilization phase.

At the end of 40 weeks, patients receiving tacrolimus ointment had 177 flare-free treatment days (the primary end point) versus 134 for those in the placebo group—a difference that reached statistical significance. Moreover, the time to first relapse was 169 days for patients who received tacrolimus and 43 days in the placebo group, and tacrolimus was associated with fewer total relapse days (45.5 days) than the placebo vehicle (64.5 days). Among patients in the tacrolimus group, 6% experienced disease relapse, compared with 17% in the vehicle group.

Adverse events primarily involved itching and burning and occurred predominantly in the stabilization phase of the study. The only significant difference in adverse events was seen at day 4 of the stabilization phase, with 18% (33 patients) in the tacrolimus group reporting any adverse event versus 9% (17 patients) in the corticosteroid group, Dr. Fleischer said.

Although tacrolimus was effective in this study population, efficacy might vary in other groups, given the widely divergent presentation possible with atopic dermatitis.

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Long-term use of tacrolimus ointment was effective in managing atopic dermatitis and preventing disease flares in a group of adults and children, Dr. Alan B. Fleischer said in a poster presented at the American Academy of Dermatology's Academy 2007 meeting.

Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and his colleagues enrolled 383 patients with at least moderate atopic dermatitis in a study sponsored by Astellas Pharma Inc., manufacturer of tacrolimus (Protopic).

Patients first went through a 16-week, randomized, double-blinded disease-stabilization phase. In the first 4 days, 190 patients received twice-daily doses of tacrolimus ointment (0.1% for adult patients and 0.03% for pediatric patients) and 193 patients received a corticosteroid twice a day. For the remaining portion of the stabilization phase, they received twice-daily open-label tacrolimus ointment until clear or almost clear of disease for at least 2 weeks, up to 16 weeks.

For the maintenance phase of the trial, patients with clear or nearly clear skin were randomly assigned to either tacrolimus ointment (125 patients) or a placebo vehicle (72 patients) in a double-blind fashion. Both were applied three times a week for up to 40 weeks. Patients who relapsed were given up to 8 weeks of open-label tacrolimus twice a day until clear or almost clear of their atopic dermatitis, at which point they returned to the study regimen. Patients whose disease did not achieve this response dropped out of the study.

Use of corticosteroids was permitted only in the initial portion of the stabilization phase.

At the end of 40 weeks, patients receiving tacrolimus ointment had 177 flare-free treatment days (the primary end point) versus 134 for those in the placebo group—a difference that reached statistical significance. Moreover, the time to first relapse was 169 days for patients who received tacrolimus and 43 days in the placebo group, and tacrolimus was associated with fewer total relapse days (45.5 days) than the placebo vehicle (64.5 days). Among patients in the tacrolimus group, 6% experienced disease relapse, compared with 17% in the vehicle group.

Adverse events primarily involved itching and burning and occurred predominantly in the stabilization phase of the study. The only significant difference in adverse events was seen at day 4 of the stabilization phase, with 18% (33 patients) in the tacrolimus group reporting any adverse event versus 9% (17 patients) in the corticosteroid group, Dr. Fleischer said.

Although tacrolimus was effective in this study population, efficacy might vary in other groups, given the widely divergent presentation possible with atopic dermatitis.

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK —Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.

A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.

Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.

In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:151–7). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.

EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.

The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.

The difference became greater with time and achieved significance at week 3. DR. FLEISCHER

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK —Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.

A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.

Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.

In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:151–7). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.

EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.

The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.

The difference became greater with time and achieved significance at week 3. DR. FLEISCHER

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK —Tacrolimus ointment is more effective than pimecrolimus cream in treating adults with moderate to severe atopic dermatitis, results from a randomized, blinded, multicenter trial indicate.

A total of 281 study patients were randomly assigned to receive tacrolimus 0.1% ointment or pimecrolimus 1% cream (141 and 140 patients, respectively), Dr. Alan B. Fleischer Jr. reported at the American Academy of Dermatology's Academy 2007 meeting.

Patient characteristics were similar in the two groups. Patients were at least 16 years old, and the mean age of each group was 40 years and 39 years, respectively, noted Dr. Fleischer of Wake Forest University, Winston-Salem, N.C., and colleagues. The study, which was sponsored by Astellas Pharma US Inc., was presented and discussed in a poster session at the meeting. Dr. Fleischer disclosed that he has received funding from Astellas as well as from Novartis.

In both groups, patients applied the medication twice daily for up to 6 weeks, until the disease cleared. The primary end point was change in disease severity between baseline and week 6 using Eczema Area Severity Index (EASI) scoring (J. Dermatol. Treat. 2007;18:151–7). Secondary end points were treatment success as measured by the Investigators' Global Atopic Dermatitis Assessment (IGADA); reduction in affected body surface area (BSA); change in the patient's self-assessment of itching; and the incidence of adverse events.

EASI scores improved by a mean of 57% from baseline in the tacrolimus patients, versus 39% in the pimecrolimus patients. This difference became greater with time and achieved statistical significance at week 3. At 6 months, the tacrolimus group had more favorable results on some secondary outcomes, compared with the pimecrolimus group: 40% vs. 22% rated as "clear" or "almost clear" on IGADA; 49% vs. 34% improvement in BSA, respectively.

The improvement in mean itch rating via the visual analog scale was more favorable for tacrolimus but did not reach significance. Both groups began with a mean score of 6.7. In the tacrolimus group, it fell to 3.2 by week 6, and in the pimecrolimus group, it dropped to 3.8. Adverse events occurring in both groups included application-site burning and application-site pruritus. The pimecrolimus group alone had one report each of skin infection, impetigo, infected dermatitis, and herpes simplex.

The difference became greater with time and achieved significance at week 3. DR. FLEISCHER

ELSEVIER GLOBAL MEDICAL NEWS

New data supplied by AstraZeneca, maker of the prescription proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), do not suggest that either drug increases cardiovascular event risks in patients with severe gastroesophageal reflux disease, according a preliminary conclusion announced by the Food and Drug Administration.

Physicians and other providers should not change their prescribing practices for either drug, the agency said.

The new information contradicts earlier data from two small, ongoing studies that the company provided to the FDA earlier this year. These data suggested that patients who took either drug were at increased risk for cardiovascular events, including myocardial infarction and heart failure. The agency did not issue a safety warning at that time.

In a teleconference and in the FDA's first-ever “early communication” statement, the agency noted that the increased cardiovascular risk seen in AstraZeneca's two initial trials was likely caused by older patient age and more extensive history of heart problems in patients who received either drug for treatment of GERD, compared with patients who instead underwent surgery for their disease.

Dr. Paul Seligman, associate director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER), said, “The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, or heart-related sudden death in those patients taking either one of the drugs, compared to patients who received surgery.”

The company has since provided the agency with additional follow-up data from the original two studies, as well as data from 14 additional studies, 4 of which were placebo controlled. Despite the agency's earlier concerns, the new data indicate that many patients who had been randomly assigned to undergo surgery dropped out before the planned procedure, leaving a younger, healthier group of patients in the surgery group. “Upon initial examination and review of all available data that we have to date, the FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products.”

The FDA has been in contact with its counterparts in the United Kingdom, Australia, New Zealand, and Canada, where similar reviews are taking place. Data from these independent reviews support the FDA's preliminary findings, he said.

He added that the new announcement will not result in any changes to direct-to-consumer advertising for either drug. As to whether manufacturers of other PPIs would be asked for additional data on their products, the agency is “in the process of accumulating as much data as we can about all of these products,” he said.

Dr. Seligman also noted that the communication does not apply to the over-the-counter version of omeprazole, Prilosec OTC, manufactured by Procter & Gamble.

Dr. Julie Beitz, director of CDER's Office of Drug Evaluation III, said that specific information on what conditions were controlled for and what type of statistical analysis was conducted for any of the studies will be available upon completion of the agency's safety review of both drugs. That should occur in early November, Dr. Seligman said.

The early communication statement is available at www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole-htm

New data supplied by AstraZeneca, maker of the prescription proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), do not suggest that either drug increases cardiovascular event risks in patients with severe gastroesophageal reflux disease, according a preliminary conclusion announced by the Food and Drug Administration.

Physicians and other providers should not change their prescribing practices for either drug, the agency said.

The new information contradicts earlier data from two small, ongoing studies that the company provided to the FDA earlier this year. These data suggested that patients who took either drug were at increased risk for cardiovascular events, including myocardial infarction and heart failure. The agency did not issue a safety warning at that time.

In a teleconference and in the FDA's first-ever “early communication” statement, the agency noted that the increased cardiovascular risk seen in AstraZeneca's two initial trials was likely caused by older patient age and more extensive history of heart problems in patients who received either drug for treatment of GERD, compared with patients who instead underwent surgery for their disease.

Dr. Paul Seligman, associate director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER), said, “The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, or heart-related sudden death in those patients taking either one of the drugs, compared to patients who received surgery.”

The company has since provided the agency with additional follow-up data from the original two studies, as well as data from 14 additional studies, 4 of which were placebo controlled. Despite the agency's earlier concerns, the new data indicate that many patients who had been randomly assigned to undergo surgery dropped out before the planned procedure, leaving a younger, healthier group of patients in the surgery group. “Upon initial examination and review of all available data that we have to date, the FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products.”

The FDA has been in contact with its counterparts in the United Kingdom, Australia, New Zealand, and Canada, where similar reviews are taking place. Data from these independent reviews support the FDA's preliminary findings, he said.

He added that the new announcement will not result in any changes to direct-to-consumer advertising for either drug. As to whether manufacturers of other PPIs would be asked for additional data on their products, the agency is “in the process of accumulating as much data as we can about all of these products,” he said.

Dr. Seligman also noted that the communication does not apply to the over-the-counter version of omeprazole, Prilosec OTC, manufactured by Procter & Gamble.

Dr. Julie Beitz, director of CDER's Office of Drug Evaluation III, said that specific information on what conditions were controlled for and what type of statistical analysis was conducted for any of the studies will be available upon completion of the agency's safety review of both drugs. That should occur in early November, Dr. Seligman said.

The early communication statement is available at www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole-htm

New data supplied by AstraZeneca, maker of the prescription proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), do not suggest that either drug increases cardiovascular event risks in patients with severe gastroesophageal reflux disease, according a preliminary conclusion announced by the Food and Drug Administration.

Physicians and other providers should not change their prescribing practices for either drug, the agency said.

The new information contradicts earlier data from two small, ongoing studies that the company provided to the FDA earlier this year. These data suggested that patients who took either drug were at increased risk for cardiovascular events, including myocardial infarction and heart failure. The agency did not issue a safety warning at that time.

In a teleconference and in the FDA's first-ever “early communication” statement, the agency noted that the increased cardiovascular risk seen in AstraZeneca's two initial trials was likely caused by older patient age and more extensive history of heart problems in patients who received either drug for treatment of GERD, compared with patients who instead underwent surgery for their disease.

Dr. Paul Seligman, associate director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER), said, “The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, or heart-related sudden death in those patients taking either one of the drugs, compared to patients who received surgery.”

The company has since provided the agency with additional follow-up data from the original two studies, as well as data from 14 additional studies, 4 of which were placebo controlled. Despite the agency's earlier concerns, the new data indicate that many patients who had been randomly assigned to undergo surgery dropped out before the planned procedure, leaving a younger, healthier group of patients in the surgery group. “Upon initial examination and review of all available data that we have to date, the FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products.”

The FDA has been in contact with its counterparts in the United Kingdom, Australia, New Zealand, and Canada, where similar reviews are taking place. Data from these independent reviews support the FDA's preliminary findings, he said.

He added that the new announcement will not result in any changes to direct-to-consumer advertising for either drug. As to whether manufacturers of other PPIs would be asked for additional data on their products, the agency is “in the process of accumulating as much data as we can about all of these products,” he said.

Dr. Seligman also noted that the communication does not apply to the over-the-counter version of omeprazole, Prilosec OTC, manufactured by Procter & Gamble.

Dr. Julie Beitz, director of CDER's Office of Drug Evaluation III, said that specific information on what conditions were controlled for and what type of statistical analysis was conducted for any of the studies will be available upon completion of the agency's safety review of both drugs. That should occur in early November, Dr. Seligman said.

The early communication statement is available at www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole-htm