Timothy F. Kirn

SALT LAKE CITY — Fatty liver is found in almost one in five older adolescents, a prevalence not much different from that found in adults, Dr. Jeffrey B. Schwimmer said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

That is a problem, because many of those adolescents also have steatohepatitis, and there are no treatments proven to be of reliable benefit, he said.

It is hard to know how many children have steatosis or steatohepatitis because imaging techniques are not very sensitive. In addition, many patients—even those with steatohepatitis—do not have elevated liver enzymes, which might prompt a biopsy, said Dr. Schwimmer of the department of pediatrics at the University of California, San Diego.

Previous studies estimated the prevalence of fatty liver—which was checked for only in obese children—at anywhere from 10% to 77%, and case series have suggested that from 3% to 10% of children already have cirrhosis when they are biopsied.

So Dr. Schwimmer and his colleagues reviewed the liver slides from autopsies of every child autopsied by the medical examiner in San Diego County from 1993 to 2003. They excluded those children who might be likely to have liver toxicity, such as those with alcohol in their systems, and those who had a condition affecting the liver (Pediatrics 2006;118:1388–93).

In 743 children, most of whom died in accidents or shootings, 13% were found to have a fatty liver. A fatty liver was defined as a liver in which 5% or more of hepatocytes contained a droplet of fat bigger than the cell nucleus. The prevalence ranged from a little less than 1% in children aged 2–4 years up to 17% in those aged 15–19 years. In addition, 82% of the children with fatty liver were male.

Steatohepatitis was found in 23% of the children with fatty liver, or 3% of the total population, a percentage that, translated to the entire population, would suggest that 65 million children in the United States have a fatty liver.

And it was found not only in heavy children, but in 5% of the normal-weight children, compared with 16% of overweight children and 38% of obese children.

It was more common in Hispanic and Asian children (11% and 10%, respectively) than in white children (9%), and was almost nonexistent in black children (1%).

“Blacks seem to be incredibly protected from developing fatty liver disease, regardless of their obesity,” said Dr. Schwimmer.

The benefits of any kind of treatment have not been established, he added.

Three studies have shown that weight loss can improve an elevated ALT level. But close examination of one of those studies shows that the benefit might be limited. In that study, 84 patients with biopsy-proven nonalcoholic fatty liver disease were followed for 1 year, during which they received moderate-intensity weight management (Hepatology 2006;44:458–65).

In all, 77% of those children were overweight or obese at the start, but 35 children lost no significant amount of weight over the year, and only 5 lost weight and had a normalizing of their ALT, Dr. Schwimmer said.

Metformin also seems to be of limited benefit in these patients. Dr. Schwimmer conducted a study of 10 metformin-treated obese adolescents and found that after 24 weeks of treatment only 40% achieved a normal ALT level. Magnetic resonance spectroscopy showed some reduction in liver fat, but those livers did not become “normal,” he said (Aliment. Pharmacol. Ther. 2005;21:871–9).

“I know we all want to do something to help these children; unfortunately there is an awful lot we don't know yet about exactly what that entails,” he said.

A large ongoing study sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases may help provide an answer. That study is looking at either vitamin E or metformin treatment, versus placebo, in pediatric patients, he said.

Blacks seem to be protected from developing fatty liver disease, regardless oftheir obesity. DR. SCHWIMMER

SALT LAKE CITY — Fatty liver is found in almost one in five older adolescents, a prevalence not much different from that found in adults, Dr. Jeffrey B. Schwimmer said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

That is a problem, because many of those adolescents also have steatohepatitis, and there are no treatments proven to be of reliable benefit, he said.

It is hard to know how many children have steatosis or steatohepatitis because imaging techniques are not very sensitive. In addition, many patients—even those with steatohepatitis—do not have elevated liver enzymes, which might prompt a biopsy, said Dr. Schwimmer of the department of pediatrics at the University of California, San Diego.

Previous studies estimated the prevalence of fatty liver—which was checked for only in obese children—at anywhere from 10% to 77%, and case series have suggested that from 3% to 10% of children already have cirrhosis when they are biopsied.

So Dr. Schwimmer and his colleagues reviewed the liver slides from autopsies of every child autopsied by the medical examiner in San Diego County from 1993 to 2003. They excluded those children who might be likely to have liver toxicity, such as those with alcohol in their systems, and those who had a condition affecting the liver (Pediatrics 2006;118:1388–93).

In 743 children, most of whom died in accidents or shootings, 13% were found to have a fatty liver. A fatty liver was defined as a liver in which 5% or more of hepatocytes contained a droplet of fat bigger than the cell nucleus. The prevalence ranged from a little less than 1% in children aged 2–4 years up to 17% in those aged 15–19 years. In addition, 82% of the children with fatty liver were male.

Steatohepatitis was found in 23% of the children with fatty liver, or 3% of the total population, a percentage that, translated to the entire population, would suggest that 65 million children in the United States have a fatty liver.

And it was found not only in heavy children, but in 5% of the normal-weight children, compared with 16% of overweight children and 38% of obese children.

It was more common in Hispanic and Asian children (11% and 10%, respectively) than in white children (9%), and was almost nonexistent in black children (1%).

“Blacks seem to be incredibly protected from developing fatty liver disease, regardless of their obesity,” said Dr. Schwimmer.

The benefits of any kind of treatment have not been established, he added.

Three studies have shown that weight loss can improve an elevated ALT level. But close examination of one of those studies shows that the benefit might be limited. In that study, 84 patients with biopsy-proven nonalcoholic fatty liver disease were followed for 1 year, during which they received moderate-intensity weight management (Hepatology 2006;44:458–65).

In all, 77% of those children were overweight or obese at the start, but 35 children lost no significant amount of weight over the year, and only 5 lost weight and had a normalizing of their ALT, Dr. Schwimmer said.

Metformin also seems to be of limited benefit in these patients. Dr. Schwimmer conducted a study of 10 metformin-treated obese adolescents and found that after 24 weeks of treatment only 40% achieved a normal ALT level. Magnetic resonance spectroscopy showed some reduction in liver fat, but those livers did not become “normal,” he said (Aliment. Pharmacol. Ther. 2005;21:871–9).

“I know we all want to do something to help these children; unfortunately there is an awful lot we don't know yet about exactly what that entails,” he said.

A large ongoing study sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases may help provide an answer. That study is looking at either vitamin E or metformin treatment, versus placebo, in pediatric patients, he said.

Blacks seem to be protected from developing fatty liver disease, regardless oftheir obesity. DR. SCHWIMMER

SALT LAKE CITY — Fatty liver is found in almost one in five older adolescents, a prevalence not much different from that found in adults, Dr. Jeffrey B. Schwimmer said at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

That is a problem, because many of those adolescents also have steatohepatitis, and there are no treatments proven to be of reliable benefit, he said.

It is hard to know how many children have steatosis or steatohepatitis because imaging techniques are not very sensitive. In addition, many patients—even those with steatohepatitis—do not have elevated liver enzymes, which might prompt a biopsy, said Dr. Schwimmer of the department of pediatrics at the University of California, San Diego.

Previous studies estimated the prevalence of fatty liver—which was checked for only in obese children—at anywhere from 10% to 77%, and case series have suggested that from 3% to 10% of children already have cirrhosis when they are biopsied.

So Dr. Schwimmer and his colleagues reviewed the liver slides from autopsies of every child autopsied by the medical examiner in San Diego County from 1993 to 2003. They excluded those children who might be likely to have liver toxicity, such as those with alcohol in their systems, and those who had a condition affecting the liver (Pediatrics 2006;118:1388–93).

In 743 children, most of whom died in accidents or shootings, 13% were found to have a fatty liver. A fatty liver was defined as a liver in which 5% or more of hepatocytes contained a droplet of fat bigger than the cell nucleus. The prevalence ranged from a little less than 1% in children aged 2–4 years up to 17% in those aged 15–19 years. In addition, 82% of the children with fatty liver were male.

Steatohepatitis was found in 23% of the children with fatty liver, or 3% of the total population, a percentage that, translated to the entire population, would suggest that 65 million children in the United States have a fatty liver.

And it was found not only in heavy children, but in 5% of the normal-weight children, compared with 16% of overweight children and 38% of obese children.

It was more common in Hispanic and Asian children (11% and 10%, respectively) than in white children (9%), and was almost nonexistent in black children (1%).

“Blacks seem to be incredibly protected from developing fatty liver disease, regardless of their obesity,” said Dr. Schwimmer.

The benefits of any kind of treatment have not been established, he added.

Three studies have shown that weight loss can improve an elevated ALT level. But close examination of one of those studies shows that the benefit might be limited. In that study, 84 patients with biopsy-proven nonalcoholic fatty liver disease were followed for 1 year, during which they received moderate-intensity weight management (Hepatology 2006;44:458–65).

In all, 77% of those children were overweight or obese at the start, but 35 children lost no significant amount of weight over the year, and only 5 lost weight and had a normalizing of their ALT, Dr. Schwimmer said.

Metformin also seems to be of limited benefit in these patients. Dr. Schwimmer conducted a study of 10 metformin-treated obese adolescents and found that after 24 weeks of treatment only 40% achieved a normal ALT level. Magnetic resonance spectroscopy showed some reduction in liver fat, but those livers did not become “normal,” he said (Aliment. Pharmacol. Ther. 2005;21:871–9).

“I know we all want to do something to help these children; unfortunately there is an awful lot we don't know yet about exactly what that entails,” he said.

A large ongoing study sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases may help provide an answer. That study is looking at either vitamin E or metformin treatment, versus placebo, in pediatric patients, he said.

Blacks seem to be protected from developing fatty liver disease, regardless oftheir obesity. DR. SCHWIMMER

SALT LAKE CITY — Many physicians who see a patient with acute gastroenteritis suggest the patient go home and eat some yogurt, in Dr. Yoram Elitsur's experience. But, most commercial yogurt probably contains too little Lactobacillus species to be of any use, according to his testing of 10 popular brands.

“I am not saying they are cheating us,” Dr. Elitsur, director of pediatric gastroenterology at Marshall University, Huntington, W.Va., said in an interview. “All I am saying is that there is not enough Lactobacillus in there to treat acute gastroenteritis.”

Several studies have suggested that probiotics, such as Lactobacillus and Bifidobacterium species, may be of benefit in treating acute gastroenteritis, reducing the duration of diarrhea. Surprisingly, they may be more effective when the cause of the gastroenteritis is viral, rather than bacterial, Dr. Elitsur said in a poster presentation at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

But the concentration of live Lactobacillus species needed to be present is between 109 and 1011 colony-forming units (CFU) per day.

Dr. Elitsur tested 10 brands of yogurt that said on the label that they were live- and active-culture products. He cultured them on Lactobacillus-specific agar plates, and performed polymerase chain reaction (PCR) testing to see if indeed the strains of bacteria in the yogurt were Lactobacillus acidophilus and/or Bifidobacterium bifidum, the probiotics shown most often in other studies to be beneficial in gastroenteritis. He found that only the capsule probiotic (Culturelle) that he tested and used as a control had a concentration of live bacteria in the necessary, recommended amount, and that that product had barely the minimum of 7.7 x 109 CFU. Of the 10 yogurt brands, all but one met the National Yogurt Association's minimum concentration, but none had the concentration necessary to provide a benefit for acute gastroenteritis. The brand that did not meet the National Yogurt Association's minimum concentration of 108 CFU/g was YoBaby (Stonyfield Farm), which had 4.8 x 107 CFU/g.

The other brands tested included Dannon DanActive, Dannon Fruit on the Bottom, Dannon Activia, Yoplait, Breyers Light Probiotic Plus, Breyers Fruit on the Bottom, Kroger Blended, Kroger Fruit on the Bottom, and Great Value.

The PCR testing showed that only three brands had any live Bifidobacterium species.

According to his testing, a child would have to consume about 100 containers of these yogurts in order to get enough probiotic to treat gastroenteritis, Dr. Elitsur said in the interview.

“Anyway you look at it, these companies cannot claim that their yogurt is sufficient to treat gastroenteritis in children,” he said.

But then, none of them do make that specific claim, or they would be subject to drug regulation, he added.

Dr. Elitsur said he had no conflicts of interest with any of the products mentioned.

SALT LAKE CITY — Many physicians who see a patient with acute gastroenteritis suggest the patient go home and eat some yogurt, in Dr. Yoram Elitsur's experience. But, most commercial yogurt probably contains too little Lactobacillus species to be of any use, according to his testing of 10 popular brands.

“I am not saying they are cheating us,” Dr. Elitsur, director of pediatric gastroenterology at Marshall University, Huntington, W.Va., said in an interview. “All I am saying is that there is not enough Lactobacillus in there to treat acute gastroenteritis.”

Several studies have suggested that probiotics, such as Lactobacillus and Bifidobacterium species, may be of benefit in treating acute gastroenteritis, reducing the duration of diarrhea. Surprisingly, they may be more effective when the cause of the gastroenteritis is viral, rather than bacterial, Dr. Elitsur said in a poster presentation at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

But the concentration of live Lactobacillus species needed to be present is between 109 and 1011 colony-forming units (CFU) per day.

Dr. Elitsur tested 10 brands of yogurt that said on the label that they were live- and active-culture products. He cultured them on Lactobacillus-specific agar plates, and performed polymerase chain reaction (PCR) testing to see if indeed the strains of bacteria in the yogurt were Lactobacillus acidophilus and/or Bifidobacterium bifidum, the probiotics shown most often in other studies to be beneficial in gastroenteritis. He found that only the capsule probiotic (Culturelle) that he tested and used as a control had a concentration of live bacteria in the necessary, recommended amount, and that that product had barely the minimum of 7.7 x 109 CFU. Of the 10 yogurt brands, all but one met the National Yogurt Association's minimum concentration, but none had the concentration necessary to provide a benefit for acute gastroenteritis. The brand that did not meet the National Yogurt Association's minimum concentration of 108 CFU/g was YoBaby (Stonyfield Farm), which had 4.8 x 107 CFU/g.

The other brands tested included Dannon DanActive, Dannon Fruit on the Bottom, Dannon Activia, Yoplait, Breyers Light Probiotic Plus, Breyers Fruit on the Bottom, Kroger Blended, Kroger Fruit on the Bottom, and Great Value.

The PCR testing showed that only three brands had any live Bifidobacterium species.

According to his testing, a child would have to consume about 100 containers of these yogurts in order to get enough probiotic to treat gastroenteritis, Dr. Elitsur said in the interview.

“Anyway you look at it, these companies cannot claim that their yogurt is sufficient to treat gastroenteritis in children,” he said.

But then, none of them do make that specific claim, or they would be subject to drug regulation, he added.

Dr. Elitsur said he had no conflicts of interest with any of the products mentioned.

SALT LAKE CITY — Many physicians who see a patient with acute gastroenteritis suggest the patient go home and eat some yogurt, in Dr. Yoram Elitsur's experience. But, most commercial yogurt probably contains too little Lactobacillus species to be of any use, according to his testing of 10 popular brands.

“I am not saying they are cheating us,” Dr. Elitsur, director of pediatric gastroenterology at Marshall University, Huntington, W.Va., said in an interview. “All I am saying is that there is not enough Lactobacillus in there to treat acute gastroenteritis.”

Several studies have suggested that probiotics, such as Lactobacillus and Bifidobacterium species, may be of benefit in treating acute gastroenteritis, reducing the duration of diarrhea. Surprisingly, they may be more effective when the cause of the gastroenteritis is viral, rather than bacterial, Dr. Elitsur said in a poster presentation at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

But the concentration of live Lactobacillus species needed to be present is between 109 and 1011 colony-forming units (CFU) per day.

Dr. Elitsur tested 10 brands of yogurt that said on the label that they were live- and active-culture products. He cultured them on Lactobacillus-specific agar plates, and performed polymerase chain reaction (PCR) testing to see if indeed the strains of bacteria in the yogurt were Lactobacillus acidophilus and/or Bifidobacterium bifidum, the probiotics shown most often in other studies to be beneficial in gastroenteritis. He found that only the capsule probiotic (Culturelle) that he tested and used as a control had a concentration of live bacteria in the necessary, recommended amount, and that that product had barely the minimum of 7.7 x 109 CFU. Of the 10 yogurt brands, all but one met the National Yogurt Association's minimum concentration, but none had the concentration necessary to provide a benefit for acute gastroenteritis. The brand that did not meet the National Yogurt Association's minimum concentration of 108 CFU/g was YoBaby (Stonyfield Farm), which had 4.8 x 107 CFU/g.

The other brands tested included Dannon DanActive, Dannon Fruit on the Bottom, Dannon Activia, Yoplait, Breyers Light Probiotic Plus, Breyers Fruit on the Bottom, Kroger Blended, Kroger Fruit on the Bottom, and Great Value.

The PCR testing showed that only three brands had any live Bifidobacterium species.

According to his testing, a child would have to consume about 100 containers of these yogurts in order to get enough probiotic to treat gastroenteritis, Dr. Elitsur said in the interview.

“Anyway you look at it, these companies cannot claim that their yogurt is sufficient to treat gastroenteritis in children,” he said.

But then, none of them do make that specific claim, or they would be subject to drug regulation, he added.

Dr. Elitsur said he had no conflicts of interest with any of the products mentioned.

Many patients with diabetes might prefer to have some risk of minor complications from the disease than to live life saddled with the rigors of comprehensive diabetes management, according to a survey conducted by researchers at the University of Chicago.

In their 1-hour, face-to-face survey interviews with 701 patients with diabetes, investigators found that patients certainly preferred life with treatment to life with complications, Dr. Elbert S. Huang, of the section of general internal medicine at the University of Chicago, and his colleagues reported. But they also found that patients perceived comprehensive diabetes care as having many negative impacts on quality of life—impacts that they rated as about equal to a number of intermediate complications (Diabetes Care 2007;30:1–6).

The researchers described comprehensive care to the study subjects as management that entailed cholesterol-lowering drugs, aspirin, intensive blood pressure control (perhaps with more than one agent), intensive glucose control (perhaps with insulin and oral agents, and close monitoring), and diet and exercise.

The patients ranked intensive control and comprehensive control significantly lower than conventional control. And, the mean rating for comprehensive care was not statistically different from the ratings for angina, diabetic neuropathy, and diabetic nephropathy. The mean rating for intensive therapy, which was demanding but not quite as taxing as comprehensive care, was similar to that of diabetic neuropathy.

Despite those overall findings, Dr. Huang noted that there was much variation in the way the patients answered the questions. The majority actually rated life with treatments as being close to perfect health, and only 18% rated life with treatments as being a significant burden on quality of life.

The study was conducted, Dr. Huang said, because although numerous studies have shown that intensive diabetes control reduces complications and much effort and money is expended to encourage intensive management, at least 20% of patients continue to have poor glycemic control, 33% have suboptimal blood pressure, and 40% have high cholesterol.

The survey may give some insight into why patients with diabetes so often do not meet recommended treatment targets, he said.

The study used a quantitative scale to rate patient preferences, or “utilities,” so answers about treatments and complications could be compared.

The heterogeneity of responses indicates that doctors need to talk to their patients in the clinic and share decision making when making treatment plans, Dr. Huang said.

Many patients with diabetes might prefer to have some risk of minor complications from the disease than to live life saddled with the rigors of comprehensive diabetes management, according to a survey conducted by researchers at the University of Chicago.

In their 1-hour, face-to-face survey interviews with 701 patients with diabetes, investigators found that patients certainly preferred life with treatment to life with complications, Dr. Elbert S. Huang, of the section of general internal medicine at the University of Chicago, and his colleagues reported. But they also found that patients perceived comprehensive diabetes care as having many negative impacts on quality of life—impacts that they rated as about equal to a number of intermediate complications (Diabetes Care 2007;30:1–6).

The researchers described comprehensive care to the study subjects as management that entailed cholesterol-lowering drugs, aspirin, intensive blood pressure control (perhaps with more than one agent), intensive glucose control (perhaps with insulin and oral agents, and close monitoring), and diet and exercise.

The patients ranked intensive control and comprehensive control significantly lower than conventional control. And, the mean rating for comprehensive care was not statistically different from the ratings for angina, diabetic neuropathy, and diabetic nephropathy. The mean rating for intensive therapy, which was demanding but not quite as taxing as comprehensive care, was similar to that of diabetic neuropathy.

Despite those overall findings, Dr. Huang noted that there was much variation in the way the patients answered the questions. The majority actually rated life with treatments as being close to perfect health, and only 18% rated life with treatments as being a significant burden on quality of life.

The study was conducted, Dr. Huang said, because although numerous studies have shown that intensive diabetes control reduces complications and much effort and money is expended to encourage intensive management, at least 20% of patients continue to have poor glycemic control, 33% have suboptimal blood pressure, and 40% have high cholesterol.

The survey may give some insight into why patients with diabetes so often do not meet recommended treatment targets, he said.

The study used a quantitative scale to rate patient preferences, or “utilities,” so answers about treatments and complications could be compared.

The heterogeneity of responses indicates that doctors need to talk to their patients in the clinic and share decision making when making treatment plans, Dr. Huang said.

Many patients with diabetes might prefer to have some risk of minor complications from the disease than to live life saddled with the rigors of comprehensive diabetes management, according to a survey conducted by researchers at the University of Chicago.

In their 1-hour, face-to-face survey interviews with 701 patients with diabetes, investigators found that patients certainly preferred life with treatment to life with complications, Dr. Elbert S. Huang, of the section of general internal medicine at the University of Chicago, and his colleagues reported. But they also found that patients perceived comprehensive diabetes care as having many negative impacts on quality of life—impacts that they rated as about equal to a number of intermediate complications (Diabetes Care 2007;30:1–6).

The researchers described comprehensive care to the study subjects as management that entailed cholesterol-lowering drugs, aspirin, intensive blood pressure control (perhaps with more than one agent), intensive glucose control (perhaps with insulin and oral agents, and close monitoring), and diet and exercise.

The patients ranked intensive control and comprehensive control significantly lower than conventional control. And, the mean rating for comprehensive care was not statistically different from the ratings for angina, diabetic neuropathy, and diabetic nephropathy. The mean rating for intensive therapy, which was demanding but not quite as taxing as comprehensive care, was similar to that of diabetic neuropathy.

Despite those overall findings, Dr. Huang noted that there was much variation in the way the patients answered the questions. The majority actually rated life with treatments as being close to perfect health, and only 18% rated life with treatments as being a significant burden on quality of life.

The study was conducted, Dr. Huang said, because although numerous studies have shown that intensive diabetes control reduces complications and much effort and money is expended to encourage intensive management, at least 20% of patients continue to have poor glycemic control, 33% have suboptimal blood pressure, and 40% have high cholesterol.

The survey may give some insight into why patients with diabetes so often do not meet recommended treatment targets, he said.

The study used a quantitative scale to rate patient preferences, or “utilities,” so answers about treatments and complications could be compared.

The heterogeneity of responses indicates that doctors need to talk to their patients in the clinic and share decision making when making treatment plans, Dr. Huang said.

Both too much sleep and not enough sleep appear to be associated with increased mortality, according to a new longitudinal study.

Sleeping less than 6 hours per night or more than 9 hours per night was associated with almost twice the mortality risk of sleeping 6–8 hours per night, according to an analysis of sleep data from a prospective cohort study of more than 10,000 British civil servants.

The findings were recently presented at a meeting of the British Sleep Society, and the research article has been accepted for publication in the journal Sleep.

The investigators found that a decrease in the amount of time slept was associated with increased mortality from cardiovascular causes. An increase in sleep time was associated with an excess of mortality from all other causes, according to Jane Ferrie, Ph.D., of University College London, and her colleagues.

Previous studies have reported a U-shaped relationship between time spent sleeping and mortality, the investigators said. What has not been looked at by a sleep study before is the effect a change in sleep patterns might have.

The researchers examined sleep data collected from British civil service employees aged 35–55 years who were enrolled beginning in 1985 in a long-term study known as Whitehall II. Baseline sleep duration data were available for 9,781 subjects who were interviewed in 1985–1988, while follow-up data were available for 7,729 who were interviewed again in 1992–1993. Mortality data were available through September 2004.

After adjustment for factors such as age, sex, smoking status, body mass index, cholesterol, and physical activity, those Whitehall II participants who reported sleeping 5 hours or less a night at the first interview had a hazard ratio of death from all causes of 1.24, relative to those who slept 7 hours per night. Those who slept 9 hours or more had a fully adjusted hazard ratio of 1.54.

The fully adjusted hazard ratios of all-cause mortality were slightly higher for those who reported sleep for 5 hours or less and 9 hours or more at the second interview, 1.78 and 1.95, respectively. The risk of death due to cardiovascular causes was relatively greater for those who slept less after the baseline period than for those who slept more.

Participants whose sleep decreased from 6–8 hours a night at the first interview to less than 6 hours at the second interview had a fully adjusted hazard ratio of mortality from cardiovascular cause of 2.04, compared with 1.22 for those who slept more. Those whose sleep increased from 7–8 hours at the first interview to more than 8 hours at the second interview had a fully adjusted hazard ratio of mortality from noncardiovascular causes of 2.06, compared with 1.44 for those who slept less.

Investigators found a positive association between marital status and sleep duration. Married women were more likely to sleep longer, while married men were more likely to average 7–8 hours of sleep per night.

The connection between sleep duration and body mass index wasn't as clear cut. At the Whitehall II study's baseline, higher BMI was associated both with short and long sleep duration in women, but only with short sleep duration in men. By 1992–1993, BMI and sleep duration showed no association in women, but both short and long sleep durations were associated with higher BMI in men.

“Patients reporting a decrease in sleep should be regarded as higher risk populations for cardiovascular and all-cause mortality,” according to the investigators. Advising patients who may sleep too long to curtail their sleep should “at least be considered,” the investigators wrote.

Both too much sleep and not enough sleep appear to be associated with increased mortality, according to a new longitudinal study.

Sleeping less than 6 hours per night or more than 9 hours per night was associated with almost twice the mortality risk of sleeping 6–8 hours per night, according to an analysis of sleep data from a prospective cohort study of more than 10,000 British civil servants.

The findings were recently presented at a meeting of the British Sleep Society, and the research article has been accepted for publication in the journal Sleep.

The investigators found that a decrease in the amount of time slept was associated with increased mortality from cardiovascular causes. An increase in sleep time was associated with an excess of mortality from all other causes, according to Jane Ferrie, Ph.D., of University College London, and her colleagues.

Previous studies have reported a U-shaped relationship between time spent sleeping and mortality, the investigators said. What has not been looked at by a sleep study before is the effect a change in sleep patterns might have.

The researchers examined sleep data collected from British civil service employees aged 35–55 years who were enrolled beginning in 1985 in a long-term study known as Whitehall II. Baseline sleep duration data were available for 9,781 subjects who were interviewed in 1985–1988, while follow-up data were available for 7,729 who were interviewed again in 1992–1993. Mortality data were available through September 2004.

After adjustment for factors such as age, sex, smoking status, body mass index, cholesterol, and physical activity, those Whitehall II participants who reported sleeping 5 hours or less a night at the first interview had a hazard ratio of death from all causes of 1.24, relative to those who slept 7 hours per night. Those who slept 9 hours or more had a fully adjusted hazard ratio of 1.54.

The fully adjusted hazard ratios of all-cause mortality were slightly higher for those who reported sleep for 5 hours or less and 9 hours or more at the second interview, 1.78 and 1.95, respectively. The risk of death due to cardiovascular causes was relatively greater for those who slept less after the baseline period than for those who slept more.

Participants whose sleep decreased from 6–8 hours a night at the first interview to less than 6 hours at the second interview had a fully adjusted hazard ratio of mortality from cardiovascular cause of 2.04, compared with 1.22 for those who slept more. Those whose sleep increased from 7–8 hours at the first interview to more than 8 hours at the second interview had a fully adjusted hazard ratio of mortality from noncardiovascular causes of 2.06, compared with 1.44 for those who slept less.

Investigators found a positive association between marital status and sleep duration. Married women were more likely to sleep longer, while married men were more likely to average 7–8 hours of sleep per night.

The connection between sleep duration and body mass index wasn't as clear cut. At the Whitehall II study's baseline, higher BMI was associated both with short and long sleep duration in women, but only with short sleep duration in men. By 1992–1993, BMI and sleep duration showed no association in women, but both short and long sleep durations were associated with higher BMI in men.

“Patients reporting a decrease in sleep should be regarded as higher risk populations for cardiovascular and all-cause mortality,” according to the investigators. Advising patients who may sleep too long to curtail their sleep should “at least be considered,” the investigators wrote.

Both too much sleep and not enough sleep appear to be associated with increased mortality, according to a new longitudinal study.

Sleeping less than 6 hours per night or more than 9 hours per night was associated with almost twice the mortality risk of sleeping 6–8 hours per night, according to an analysis of sleep data from a prospective cohort study of more than 10,000 British civil servants.

The findings were recently presented at a meeting of the British Sleep Society, and the research article has been accepted for publication in the journal Sleep.

The investigators found that a decrease in the amount of time slept was associated with increased mortality from cardiovascular causes. An increase in sleep time was associated with an excess of mortality from all other causes, according to Jane Ferrie, Ph.D., of University College London, and her colleagues.

Previous studies have reported a U-shaped relationship between time spent sleeping and mortality, the investigators said. What has not been looked at by a sleep study before is the effect a change in sleep patterns might have.

The researchers examined sleep data collected from British civil service employees aged 35–55 years who were enrolled beginning in 1985 in a long-term study known as Whitehall II. Baseline sleep duration data were available for 9,781 subjects who were interviewed in 1985–1988, while follow-up data were available for 7,729 who were interviewed again in 1992–1993. Mortality data were available through September 2004.

After adjustment for factors such as age, sex, smoking status, body mass index, cholesterol, and physical activity, those Whitehall II participants who reported sleeping 5 hours or less a night at the first interview had a hazard ratio of death from all causes of 1.24, relative to those who slept 7 hours per night. Those who slept 9 hours or more had a fully adjusted hazard ratio of 1.54.

The fully adjusted hazard ratios of all-cause mortality were slightly higher for those who reported sleep for 5 hours or less and 9 hours or more at the second interview, 1.78 and 1.95, respectively. The risk of death due to cardiovascular causes was relatively greater for those who slept less after the baseline period than for those who slept more.

Participants whose sleep decreased from 6–8 hours a night at the first interview to less than 6 hours at the second interview had a fully adjusted hazard ratio of mortality from cardiovascular cause of 2.04, compared with 1.22 for those who slept more. Those whose sleep increased from 7–8 hours at the first interview to more than 8 hours at the second interview had a fully adjusted hazard ratio of mortality from noncardiovascular causes of 2.06, compared with 1.44 for those who slept less.

Investigators found a positive association between marital status and sleep duration. Married women were more likely to sleep longer, while married men were more likely to average 7–8 hours of sleep per night.

The connection between sleep duration and body mass index wasn't as clear cut. At the Whitehall II study's baseline, higher BMI was associated both with short and long sleep duration in women, but only with short sleep duration in men. By 1992–1993, BMI and sleep duration showed no association in women, but both short and long sleep durations were associated with higher BMI in men.

“Patients reporting a decrease in sleep should be regarded as higher risk populations for cardiovascular and all-cause mortality,” according to the investigators. Advising patients who may sleep too long to curtail their sleep should “at least be considered,” the investigators wrote.

A mother who smokes and breast-feeds appears to be giving her infant a dose of nicotine that significantly interferes with the baby's sleep, according to the results of a study.

Infants spent an average of about a third less time sleeping after their mothers smoked just prior to breast-feeding, compared with when the mothers refrained, wrote Julie A. Mennella, Ph.D., and her associates at the Monell Chemical Senses Center in Philadelphia.

Nicotine is not listed as a drug that is contraindicated during breast-feeding because the benefits of breast-feeding are considered to be so great, Dr. Mennella and her associates noted.

But the presence of nicotine in breast milk could have many adverse consequences.

Mothers who smoke are known to wean their children earlier than are mothers who do not. It might be that sleep-deprived infants tend to be fussier and, if the sleep deprivation occurs because of smoking, the fussiness may stop when the mother stops breast-feeding. That in turn may reinforce a smoking mother's decision to wean, they suggested.

Sleep also is known to be important for learning and development, and therefore disruption of sleep caused by smoking could have lasting consequences, they said.

Lastly, adolescents whose mothers smoked during their early life are more likely to smoke, and this may sometimes be because they recognize the tobacco-related flavors from breast milk, and come to appreciate them.

The study was conducted with 15 volunteer mother-infant pairs. The average age of the infants was 4 months.

The mothers were brought into a testing center twice, and told to refrain from smoking for 12 hours before each testing session, with the last breast-feeding done about 2.5 hours before the session.

During one testing session, they were allowed to smoke at least one cigarette, in a separate room from the infant, and during one session they were not (Pediatrics 2007;120:497-502).

Nicotine levels in breast milk were measured at baseline and after smoking. The infants' sleep and awake times were monitored using an ambulatory monitor for 3.5 hours.

During the session when the mothers smoked, the estimated dose of nicotine delivered to the infants was a mean of 549 ng/kg. That compared with a mean dose of 127 ng/kg during the nonsmoking sessions.

During the nonsmoking sessions, the infants slept a mean of 84.5 minutes. That compared with a mean of 53.4 minutes during the smoking sessions. All but two of the infants slept less during the smoking session.

Both active sleep and quiet sleep were reduced with smoking, and the duration of the longest bout of sleep declined from a mean of 60 minutes during the nonsmoking session to a mean of 37 minutes during the smoking session.

With greater doses of nicotine, the reduction in active sleep was greater, Dr. Mennella and her associates said.

Mothers often cut back on their smoking during pregnancy. But then they tend to relapse to more smoking once their infants are born, the investigators said. And, this information may give them an added incentive to continue to curb their smoking while breast-feeding.

Nicotine that is stored in breast milk reaches peak levels about 30-60 minutes after the mother's smoking and then declines fairly rapidly.

A mother who smokes and breast-feeds appears to be giving her infant a dose of nicotine that significantly interferes with the baby's sleep, according to the results of a study.

Infants spent an average of about a third less time sleeping after their mothers smoked just prior to breast-feeding, compared with when the mothers refrained, wrote Julie A. Mennella, Ph.D., and her associates at the Monell Chemical Senses Center in Philadelphia.

Nicotine is not listed as a drug that is contraindicated during breast-feeding because the benefits of breast-feeding are considered to be so great, Dr. Mennella and her associates noted.

But the presence of nicotine in breast milk could have many adverse consequences.

Mothers who smoke are known to wean their children earlier than are mothers who do not. It might be that sleep-deprived infants tend to be fussier and, if the sleep deprivation occurs because of smoking, the fussiness may stop when the mother stops breast-feeding. That in turn may reinforce a smoking mother's decision to wean, they suggested.

Sleep also is known to be important for learning and development, and therefore disruption of sleep caused by smoking could have lasting consequences, they said.

Lastly, adolescents whose mothers smoked during their early life are more likely to smoke, and this may sometimes be because they recognize the tobacco-related flavors from breast milk, and come to appreciate them.

The study was conducted with 15 volunteer mother-infant pairs. The average age of the infants was 4 months.

The mothers were brought into a testing center twice, and told to refrain from smoking for 12 hours before each testing session, with the last breast-feeding done about 2.5 hours before the session.

During one testing session, they were allowed to smoke at least one cigarette, in a separate room from the infant, and during one session they were not (Pediatrics 2007;120:497-502).

Nicotine levels in breast milk were measured at baseline and after smoking. The infants' sleep and awake times were monitored using an ambulatory monitor for 3.5 hours.

During the session when the mothers smoked, the estimated dose of nicotine delivered to the infants was a mean of 549 ng/kg. That compared with a mean dose of 127 ng/kg during the nonsmoking sessions.

During the nonsmoking sessions, the infants slept a mean of 84.5 minutes. That compared with a mean of 53.4 minutes during the smoking sessions. All but two of the infants slept less during the smoking session.

Both active sleep and quiet sleep were reduced with smoking, and the duration of the longest bout of sleep declined from a mean of 60 minutes during the nonsmoking session to a mean of 37 minutes during the smoking session.

With greater doses of nicotine, the reduction in active sleep was greater, Dr. Mennella and her associates said.

Mothers often cut back on their smoking during pregnancy. But then they tend to relapse to more smoking once their infants are born, the investigators said. And, this information may give them an added incentive to continue to curb their smoking while breast-feeding.

Nicotine that is stored in breast milk reaches peak levels about 30-60 minutes after the mother's smoking and then declines fairly rapidly.

A mother who smokes and breast-feeds appears to be giving her infant a dose of nicotine that significantly interferes with the baby's sleep, according to the results of a study.

Infants spent an average of about a third less time sleeping after their mothers smoked just prior to breast-feeding, compared with when the mothers refrained, wrote Julie A. Mennella, Ph.D., and her associates at the Monell Chemical Senses Center in Philadelphia.

Nicotine is not listed as a drug that is contraindicated during breast-feeding because the benefits of breast-feeding are considered to be so great, Dr. Mennella and her associates noted.

But the presence of nicotine in breast milk could have many adverse consequences.

Mothers who smoke are known to wean their children earlier than are mothers who do not. It might be that sleep-deprived infants tend to be fussier and, if the sleep deprivation occurs because of smoking, the fussiness may stop when the mother stops breast-feeding. That in turn may reinforce a smoking mother's decision to wean, they suggested.

Sleep also is known to be important for learning and development, and therefore disruption of sleep caused by smoking could have lasting consequences, they said.

Lastly, adolescents whose mothers smoked during their early life are more likely to smoke, and this may sometimes be because they recognize the tobacco-related flavors from breast milk, and come to appreciate them.

The study was conducted with 15 volunteer mother-infant pairs. The average age of the infants was 4 months.

The mothers were brought into a testing center twice, and told to refrain from smoking for 12 hours before each testing session, with the last breast-feeding done about 2.5 hours before the session.

During one testing session, they were allowed to smoke at least one cigarette, in a separate room from the infant, and during one session they were not (Pediatrics 2007;120:497-502).

Nicotine levels in breast milk were measured at baseline and after smoking. The infants' sleep and awake times were monitored using an ambulatory monitor for 3.5 hours.

During the session when the mothers smoked, the estimated dose of nicotine delivered to the infants was a mean of 549 ng/kg. That compared with a mean dose of 127 ng/kg during the nonsmoking sessions.

During the nonsmoking sessions, the infants slept a mean of 84.5 minutes. That compared with a mean of 53.4 minutes during the smoking sessions. All but two of the infants slept less during the smoking session.

Both active sleep and quiet sleep were reduced with smoking, and the duration of the longest bout of sleep declined from a mean of 60 minutes during the nonsmoking session to a mean of 37 minutes during the smoking session.

With greater doses of nicotine, the reduction in active sleep was greater, Dr. Mennella and her associates said.

Mothers often cut back on their smoking during pregnancy. But then they tend to relapse to more smoking once their infants are born, the investigators said. And, this information may give them an added incentive to continue to curb their smoking while breast-feeding.

Nicotine that is stored in breast milk reaches peak levels about 30-60 minutes after the mother's smoking and then declines fairly rapidly.

A group of seven of the largest drug manufacturers has formed a consortium to study the genetics of serious adverse drug reactions.

The Serious Adverse Events Consortium will work closely with the Food and Drug Administration on the projects that it will undertake.

This group is one of several consortiums that were recently organized, with encouragement from the FDA, to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarray Quality Control project.

In its first two projects, the Serious Adverse Events Consortium will investigate genetic susceptibility to Stevens-Johnson syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said Arthur L. Holden, the chairman of the new consortium. The two conditions targeted in the first two projects are so rare that it will probably be necessary to study tens of thousands of individuals.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. “They will greatly increase our knowledge.” All data from the consortium will be available for public use.

The Stevens-Johnson syndrome project will be based at Columbia University, New York. The consortium expects that some results could be forthcoming by next year, Mr. Holden said.

The drug-induced liver toxicity project will include many patients enrolled in two European research networks. Drug-induced liver injury is now the leading cause of acute liver failure in the United States.

For the drug companies involved in the consortium, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor of medicine at the University of North Carolina, Chapel Hill.

Although the initial goal of the new consortium is to develop ways to identify susceptible people, the information also could improve future drug design, noted Dr. Watkins, who is not involved in the new consortium.

The consortium members include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle [England] University and Columbia University.

A group of seven of the largest drug manufacturers has formed a consortium to study the genetics of serious adverse drug reactions.

The Serious Adverse Events Consortium will work closely with the Food and Drug Administration on the projects that it will undertake.

This group is one of several consortiums that were recently organized, with encouragement from the FDA, to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarray Quality Control project.

In its first two projects, the Serious Adverse Events Consortium will investigate genetic susceptibility to Stevens-Johnson syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said Arthur L. Holden, the chairman of the new consortium. The two conditions targeted in the first two projects are so rare that it will probably be necessary to study tens of thousands of individuals.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. “They will greatly increase our knowledge.” All data from the consortium will be available for public use.

The Stevens-Johnson syndrome project will be based at Columbia University, New York. The consortium expects that some results could be forthcoming by next year, Mr. Holden said.

The drug-induced liver toxicity project will include many patients enrolled in two European research networks. Drug-induced liver injury is now the leading cause of acute liver failure in the United States.

For the drug companies involved in the consortium, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor of medicine at the University of North Carolina, Chapel Hill.

Although the initial goal of the new consortium is to develop ways to identify susceptible people, the information also could improve future drug design, noted Dr. Watkins, who is not involved in the new consortium.

The consortium members include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle [England] University and Columbia University.

A group of seven of the largest drug manufacturers has formed a consortium to study the genetics of serious adverse drug reactions.

The Serious Adverse Events Consortium will work closely with the Food and Drug Administration on the projects that it will undertake.

This group is one of several consortiums that were recently organized, with encouragement from the FDA, to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarray Quality Control project.

In its first two projects, the Serious Adverse Events Consortium will investigate genetic susceptibility to Stevens-Johnson syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said Arthur L. Holden, the chairman of the new consortium. The two conditions targeted in the first two projects are so rare that it will probably be necessary to study tens of thousands of individuals.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. “They will greatly increase our knowledge.” All data from the consortium will be available for public use.

The Stevens-Johnson syndrome project will be based at Columbia University, New York. The consortium expects that some results could be forthcoming by next year, Mr. Holden said.

The drug-induced liver toxicity project will include many patients enrolled in two European research networks. Drug-induced liver injury is now the leading cause of acute liver failure in the United States.

For the drug companies involved in the consortium, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor of medicine at the University of North Carolina, Chapel Hill.

Although the initial goal of the new consortium is to develop ways to identify susceptible people, the information also could improve future drug design, noted Dr. Watkins, who is not involved in the new consortium.

The consortium members include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle [England] University and Columbia University.

Seven drug makers have formed the Serious Adverse Events Consortium to study the genetics of serious adverse drug reactions.

The group is one of several consortiums recently organized with encouragement from the FDA to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarrary Quality Control project.

In its two first projects, the Serious Adverse Events Consortium will investigate patients' genetic susceptibility to Stevens-Johnson Syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said consortium Chairman Arthur L. Holden.

The conditions to be studied in the first two projects are so rare, tens of thousands of patients will likely need to be studied.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. All data will be available for public use.

For the drug companies, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor at the University of North Carolina, Chapel Hill.

The data also could improve future drug design, noted Dr. Watkins, who is not involved in the consortium.

“It is great the pharmaceutical companies are starting to study this area,” said Howard Coleman, CEO of Genelex Corp., Seattle, a company that does enzyme-mediated testing of drug metabolism. “It's good to see, because even with the most common drug reactions, this kind of work needs extraordinary numbers of patients.”

The consortium includes Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle (England) University and Columbia University.

Seven drug makers have formed the Serious Adverse Events Consortium to study the genetics of serious adverse drug reactions.

The group is one of several consortiums recently organized with encouragement from the FDA to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarrary Quality Control project.

In its two first projects, the Serious Adverse Events Consortium will investigate patients' genetic susceptibility to Stevens-Johnson Syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said consortium Chairman Arthur L. Holden.

The conditions to be studied in the first two projects are so rare, tens of thousands of patients will likely need to be studied.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. All data will be available for public use.

For the drug companies, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor at the University of North Carolina, Chapel Hill.

The data also could improve future drug design, noted Dr. Watkins, who is not involved in the consortium.

“It is great the pharmaceutical companies are starting to study this area,” said Howard Coleman, CEO of Genelex Corp., Seattle, a company that does enzyme-mediated testing of drug metabolism. “It's good to see, because even with the most common drug reactions, this kind of work needs extraordinary numbers of patients.”

The consortium includes Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle (England) University and Columbia University.

Seven drug makers have formed the Serious Adverse Events Consortium to study the genetics of serious adverse drug reactions.

The group is one of several consortiums recently organized with encouragement from the FDA to support costly research initiatives. Others include the Predictive Safety Testing Consortium, the Biomarkers Consortium, and the Microarrary Quality Control project.

In its two first projects, the Serious Adverse Events Consortium will investigate patients' genetic susceptibility to Stevens-Johnson Syndrome and to drug-induced liver toxicity.

The scope of such projects would be beyond the capability of any one company or institution, said consortium Chairman Arthur L. Holden.

The conditions to be studied in the first two projects are so rare, tens of thousands of patients will likely need to be studied.

“We really look forward to the results of these two projects,” said Dr. Janet Woodcock, deputy commissioner of FDA, in a teleconference announcing the partnership. All data will be available for public use.

For the drug companies, the effort could help avoid scenarios in which a few adverse events prevent the approval of drugs that cost large sums to develop. Adverse-event susceptibility information also might prevent some drugs from being taken off the market unnecessarily, Mr. Holden said.

“It is a tragedy when a drug gets to late development, and then two or three patients develop a problem and its approval gets dropped,” said Dr. Paul Watkins, an investigator with the Drug-Induced Liver Injury Network and a professor at the University of North Carolina, Chapel Hill.

The data also could improve future drug design, noted Dr. Watkins, who is not involved in the consortium.

“It is great the pharmaceutical companies are starting to study this area,” said Howard Coleman, CEO of Genelex Corp., Seattle, a company that does enzyme-mediated testing of drug metabolism. “It's good to see, because even with the most common drug reactions, this kind of work needs extraordinary numbers of patients.”

The consortium includes Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research and Development, Pfizer, Roche, Sanofi-Aventis, Wyeth, Illumina Inc., and research groups at Newcastle (England) University and Columbia University.

Mumps outbreaks can occur even among highly vaccinated populations, according to a new report on an outbreak that took place at a summer camp in upstate New York in 2005.

The outbreak had a total of 31 confirmed cases of mumps and 55% of the cases were known to have had two doses of mumps vaccine.

An analysis of the outbreak indicated that vaccination with two doses of mumps vaccine was 92% effective in preventing mumps, and vaccination with a single dose of vaccine was 80% effective (Pediatrics 2007;120:doi:10.1542/peds.2006-3451).

Nine of the cases occurred in individuals who had never been vaccinated, said Dr. Joshua K. Schaffzin of the New York State Department of Health, Albany, and his colleagues.

According to a previous report on the outbreak, the index case was a 20-year-old male camp counselor who came from the United Kingdom and had never been vaccinated against mumps.

On June 30, 2005, about 11 days after his arrival, he was evaluated in the camp infirmary for a left-sided parotitis, sore throat, and a low-grade fever.

At the time, an epidemic of mumps was occurring in the United Kingdom, with 56,390 notified cases reported in England and Wales in 2005.

But mumps was not considered by the camp health care staff, and the counselor continued working.

During July 15-23, an additional 25 cases of parotitis were seen. On July 26, the New York State Department of Health became aware of the outbreak, cases were isolated, and the camp was quarantined.

According to the new report, 541 persons were at the camp that summer, including 368 campers, whose median age was 12 years, and 173 staff members, whose median age was 21 years.

Of the campers, all had received at least one mumps vaccination, and all but two had received two vaccinations. Of the staff, 21 were known to have never been vaccinated.

Thirty-one cases of mumps were identified in the camp, despite the high rate of vaccine coverage in the camp.

Twenty-six met case definitions for mumps, and six were tested for mumps IgG and IgM. Five of those six were positive for both.

Only one of the six had ever been vaccinated, and that individual had received two doses.

Twelve of the patients were campers and the rest were staff.

Of the 29 cases with certain vaccine history, 16 cases were individuals who had received two doses of mumps vaccine. Four cases had received one dose. And, nine had never been vaccinated.

The investigators determined that the attack rate for those who had never been vaccinated was 43%.

For those who had received vaccine once, it was 9%. And, among those who had been vaccinated twice, it was 4%.

The investigators also found that, among those who had been vaccinated twice, the attack rates were lowest for those who had been vaccinated within 6 years of the outbreak (none of 72 individuals), and those who had been vaccinated more than 15 years before the outbreak (none of 3).

Among those in the middle, the attack rate was 4% for those vaccinated 6-10 years before the outbreak, and 7% for those vaccinated 11-15 years before the outbreak.

While that finding might suggest that waning immunity was playing a role in who contracted mumps, a regression analysis did not demonstrate any linearity in the attack rates by the years since last vaccination, Dr. Schaffzin said.

There was no difference in the clinical manifestations or in the duration of illness between those who had been vaccinated and those who had not, he added.

Mumps outbreaks can occur even among highly vaccinated populations, according to a new report on an outbreak that took place at a summer camp in upstate New York in 2005.

The outbreak had a total of 31 confirmed cases of mumps and 55% of the cases were known to have had two doses of mumps vaccine.

An analysis of the outbreak indicated that vaccination with two doses of mumps vaccine was 92% effective in preventing mumps, and vaccination with a single dose of vaccine was 80% effective (Pediatrics 2007;120:doi:10.1542/peds.2006-3451).

Nine of the cases occurred in individuals who had never been vaccinated, said Dr. Joshua K. Schaffzin of the New York State Department of Health, Albany, and his colleagues.

According to a previous report on the outbreak, the index case was a 20-year-old male camp counselor who came from the United Kingdom and had never been vaccinated against mumps.

On June 30, 2005, about 11 days after his arrival, he was evaluated in the camp infirmary for a left-sided parotitis, sore throat, and a low-grade fever.

At the time, an epidemic of mumps was occurring in the United Kingdom, with 56,390 notified cases reported in England and Wales in 2005.

But mumps was not considered by the camp health care staff, and the counselor continued working.

During July 15-23, an additional 25 cases of parotitis were seen. On July 26, the New York State Department of Health became aware of the outbreak, cases were isolated, and the camp was quarantined.

According to the new report, 541 persons were at the camp that summer, including 368 campers, whose median age was 12 years, and 173 staff members, whose median age was 21 years.

Of the campers, all had received at least one mumps vaccination, and all but two had received two vaccinations. Of the staff, 21 were known to have never been vaccinated.

Thirty-one cases of mumps were identified in the camp, despite the high rate of vaccine coverage in the camp.

Twenty-six met case definitions for mumps, and six were tested for mumps IgG and IgM. Five of those six were positive for both.

Only one of the six had ever been vaccinated, and that individual had received two doses.

Twelve of the patients were campers and the rest were staff.

Of the 29 cases with certain vaccine history, 16 cases were individuals who had received two doses of mumps vaccine. Four cases had received one dose. And, nine had never been vaccinated.

The investigators determined that the attack rate for those who had never been vaccinated was 43%.

For those who had received vaccine once, it was 9%. And, among those who had been vaccinated twice, it was 4%.

The investigators also found that, among those who had been vaccinated twice, the attack rates were lowest for those who had been vaccinated within 6 years of the outbreak (none of 72 individuals), and those who had been vaccinated more than 15 years before the outbreak (none of 3).

Among those in the middle, the attack rate was 4% for those vaccinated 6-10 years before the outbreak, and 7% for those vaccinated 11-15 years before the outbreak.

While that finding might suggest that waning immunity was playing a role in who contracted mumps, a regression analysis did not demonstrate any linearity in the attack rates by the years since last vaccination, Dr. Schaffzin said.

There was no difference in the clinical manifestations or in the duration of illness between those who had been vaccinated and those who had not, he added.

Mumps outbreaks can occur even among highly vaccinated populations, according to a new report on an outbreak that took place at a summer camp in upstate New York in 2005.

The outbreak had a total of 31 confirmed cases of mumps and 55% of the cases were known to have had two doses of mumps vaccine.

An analysis of the outbreak indicated that vaccination with two doses of mumps vaccine was 92% effective in preventing mumps, and vaccination with a single dose of vaccine was 80% effective (Pediatrics 2007;120:doi:10.1542/peds.2006-3451).

Nine of the cases occurred in individuals who had never been vaccinated, said Dr. Joshua K. Schaffzin of the New York State Department of Health, Albany, and his colleagues.

According to a previous report on the outbreak, the index case was a 20-year-old male camp counselor who came from the United Kingdom and had never been vaccinated against mumps.

On June 30, 2005, about 11 days after his arrival, he was evaluated in the camp infirmary for a left-sided parotitis, sore throat, and a low-grade fever.

At the time, an epidemic of mumps was occurring in the United Kingdom, with 56,390 notified cases reported in England and Wales in 2005.

But mumps was not considered by the camp health care staff, and the counselor continued working.

During July 15-23, an additional 25 cases of parotitis were seen. On July 26, the New York State Department of Health became aware of the outbreak, cases were isolated, and the camp was quarantined.

According to the new report, 541 persons were at the camp that summer, including 368 campers, whose median age was 12 years, and 173 staff members, whose median age was 21 years.

Of the campers, all had received at least one mumps vaccination, and all but two had received two vaccinations. Of the staff, 21 were known to have never been vaccinated.

Thirty-one cases of mumps were identified in the camp, despite the high rate of vaccine coverage in the camp.

Twenty-six met case definitions for mumps, and six were tested for mumps IgG and IgM. Five of those six were positive for both.

Only one of the six had ever been vaccinated, and that individual had received two doses.

Twelve of the patients were campers and the rest were staff.

Of the 29 cases with certain vaccine history, 16 cases were individuals who had received two doses of mumps vaccine. Four cases had received one dose. And, nine had never been vaccinated.

The investigators determined that the attack rate for those who had never been vaccinated was 43%.

For those who had received vaccine once, it was 9%. And, among those who had been vaccinated twice, it was 4%.

The investigators also found that, among those who had been vaccinated twice, the attack rates were lowest for those who had been vaccinated within 6 years of the outbreak (none of 72 individuals), and those who had been vaccinated more than 15 years before the outbreak (none of 3).

Among those in the middle, the attack rate was 4% for those vaccinated 6-10 years before the outbreak, and 7% for those vaccinated 11-15 years before the outbreak.

While that finding might suggest that waning immunity was playing a role in who contracted mumps, a regression analysis did not demonstrate any linearity in the attack rates by the years since last vaccination, Dr. Schaffzin said.

There was no difference in the clinical manifestations or in the duration of illness between those who had been vaccinated and those who had not, he added.

A pneumatic brace was as effective as eccentric training in resolving chronic Achilles tendon pain in a study that randomized 100 patients.

The investigators hypothesized that the brace, a device known as the AirHeel, probably does work to help resolve tendinopathy, and that perhaps combining the AirHeel brace with eccentric training—one of the more common treatments for chronic Achilles tendon pain—could yield a synergistic effect.

Instead, they found that both the brace and the training were only moderately beneficial and that the combination was a only a little better than either the brace or training alone (Am. J. Sports Med. 2007;35:1659–67).

The investigators randomized 37 patients to eccentric, calf-muscle training, 35 patients to the brace, and 28 patients to both. Some patients had pain in both Achilles tendons.

Patients who were randomized to use the brace wore it for 12 weeks.

The AirHeel brace has two interconnected air bladders. One fits under the heel and the other just above the calcaneus. As a person walks in the brace, pressure alternates between the two bladders, applying pulsating compression to reduce swelling and discomfort, and massaging the areas to enhance circulation.

The massaging may help to move away metabolites, such as glutamate or lactate, or it may help break down adhesions between the tendon, the paratenon, and the surrounding tissue. But, the mechanism has never been studied, Dr. Wolf Petersen of the department of orthopedics at the University of Muenster (Germany) and his associates said.

Likewise, several mechanisms have been suggested for the effect of eccentric training. It may enhance collagen fibril alignment, or it may rid the aggravated area of neovascularization. Nevertheless, several studies have demonstrated that eccentric exercises improve pain and function, the authors noted.

Patients randomized to exercise were told to stand on the forefoot of the injured leg, with the ankle in plantar flexion, on a step or other elevation, and then lower down slowly. They were to exercise three times daily for 12 weeks, performing three sets of 15 repetitions, with the knee straight and the knee bent.

The patients in the brace-only treatment group were instructed not to perform strengthening exercises on their own.

The patient groups were all similar in age (a mean of 42 years), body mass index (a mean of about 25 kg/m

A total of 87 of the patients previously had been advised to rest the affected leg, and most had received other treatments as well, generally nonsteroidal anti-inflammatory drugs.

Of the 100 patients enrolled, 86 patients completed the active, treatment phase of the study, and 72 patients completed the 1-year follow-up. Patients dropped out of the study for a variety of reasons, including patients who found training painful and patients who found the brace too uncomfortable. One patient in the brace group and one patient in the training group had surgery after completing their assigned treatment.

At 54 weeks, 90% of the remaining patients reported returning to their preinjury sports activity level.

Pain during daily activities, as measured by the visual analogue scale, was reduced from pretreatment by 20% in the eccentric-training group at 6 weeks, by 41% in the brace-only group, and by 22% in the combination group. But, by week 12, there was no further reduction in pain in the AirHeel group, while the eccentric-training group had further improvement, to a 60% reduction, and the combination group had further improvement, to a 56% reduction.

At the 1-year follow-up, pain still was reduced by 30% in the eccentric-training group, 27% in the brace-only group, and 53% in the combination group.

Pain during sports at 1 year was reduced 51% in the training group, 47% in the brace-only group, and 74% in the combination group.

The braces were supplied for the study by the company (Aircast, Vista, Calif.). Dr. Petersen and his associates disclosed receiving funds for research from Aircast Europe.

A pneumatic brace was as effective as eccentric training in resolving chronic Achilles tendon pain in a study that randomized 100 patients.

The investigators hypothesized that the brace, a device known as the AirHeel, probably does work to help resolve tendinopathy, and that perhaps combining the AirHeel brace with eccentric training—one of the more common treatments for chronic Achilles tendon pain—could yield a synergistic effect.

Instead, they found that both the brace and the training were only moderately beneficial and that the combination was a only a little better than either the brace or training alone (Am. J. Sports Med. 2007;35:1659–67).

The investigators randomized 37 patients to eccentric, calf-muscle training, 35 patients to the brace, and 28 patients to both. Some patients had pain in both Achilles tendons.

Patients who were randomized to use the brace wore it for 12 weeks.

The AirHeel brace has two interconnected air bladders. One fits under the heel and the other just above the calcaneus. As a person walks in the brace, pressure alternates between the two bladders, applying pulsating compression to reduce swelling and discomfort, and massaging the areas to enhance circulation.

The massaging may help to move away metabolites, such as glutamate or lactate, or it may help break down adhesions between the tendon, the paratenon, and the surrounding tissue. But, the mechanism has never been studied, Dr. Wolf Petersen of the department of orthopedics at the University of Muenster (Germany) and his associates said.

Likewise, several mechanisms have been suggested for the effect of eccentric training. It may enhance collagen fibril alignment, or it may rid the aggravated area of neovascularization. Nevertheless, several studies have demonstrated that eccentric exercises improve pain and function, the authors noted.

Patients randomized to exercise were told to stand on the forefoot of the injured leg, with the ankle in plantar flexion, on a step or other elevation, and then lower down slowly. They were to exercise three times daily for 12 weeks, performing three sets of 15 repetitions, with the knee straight and the knee bent.

The patients in the brace-only treatment group were instructed not to perform strengthening exercises on their own.

The patient groups were all similar in age (a mean of 42 years), body mass index (a mean of about 25 kg/m

A total of 87 of the patients previously had been advised to rest the affected leg, and most had received other treatments as well, generally nonsteroidal anti-inflammatory drugs.

Of the 100 patients enrolled, 86 patients completed the active, treatment phase of the study, and 72 patients completed the 1-year follow-up. Patients dropped out of the study for a variety of reasons, including patients who found training painful and patients who found the brace too uncomfortable. One patient in the brace group and one patient in the training group had surgery after completing their assigned treatment.

At 54 weeks, 90% of the remaining patients reported returning to their preinjury sports activity level.

Pain during daily activities, as measured by the visual analogue scale, was reduced from pretreatment by 20% in the eccentric-training group at 6 weeks, by 41% in the brace-only group, and by 22% in the combination group. But, by week 12, there was no further reduction in pain in the AirHeel group, while the eccentric-training group had further improvement, to a 60% reduction, and the combination group had further improvement, to a 56% reduction.

At the 1-year follow-up, pain still was reduced by 30% in the eccentric-training group, 27% in the brace-only group, and 53% in the combination group.

Pain during sports at 1 year was reduced 51% in the training group, 47% in the brace-only group, and 74% in the combination group.

The braces were supplied for the study by the company (Aircast, Vista, Calif.). Dr. Petersen and his associates disclosed receiving funds for research from Aircast Europe.

A pneumatic brace was as effective as eccentric training in resolving chronic Achilles tendon pain in a study that randomized 100 patients.

The investigators hypothesized that the brace, a device known as the AirHeel, probably does work to help resolve tendinopathy, and that perhaps combining the AirHeel brace with eccentric training—one of the more common treatments for chronic Achilles tendon pain—could yield a synergistic effect.

Instead, they found that both the brace and the training were only moderately beneficial and that the combination was a only a little better than either the brace or training alone (Am. J. Sports Med. 2007;35:1659–67).

The investigators randomized 37 patients to eccentric, calf-muscle training, 35 patients to the brace, and 28 patients to both. Some patients had pain in both Achilles tendons.

Patients who were randomized to use the brace wore it for 12 weeks.

The AirHeel brace has two interconnected air bladders. One fits under the heel and the other just above the calcaneus. As a person walks in the brace, pressure alternates between the two bladders, applying pulsating compression to reduce swelling and discomfort, and massaging the areas to enhance circulation.

The massaging may help to move away metabolites, such as glutamate or lactate, or it may help break down adhesions between the tendon, the paratenon, and the surrounding tissue. But, the mechanism has never been studied, Dr. Wolf Petersen of the department of orthopedics at the University of Muenster (Germany) and his associates said.

Likewise, several mechanisms have been suggested for the effect of eccentric training. It may enhance collagen fibril alignment, or it may rid the aggravated area of neovascularization. Nevertheless, several studies have demonstrated that eccentric exercises improve pain and function, the authors noted.

Patients randomized to exercise were told to stand on the forefoot of the injured leg, with the ankle in plantar flexion, on a step or other elevation, and then lower down slowly. They were to exercise three times daily for 12 weeks, performing three sets of 15 repetitions, with the knee straight and the knee bent.

The patients in the brace-only treatment group were instructed not to perform strengthening exercises on their own.

The patient groups were all similar in age (a mean of 42 years), body mass index (a mean of about 25 kg/m

A total of 87 of the patients previously had been advised to rest the affected leg, and most had received other treatments as well, generally nonsteroidal anti-inflammatory drugs.

Of the 100 patients enrolled, 86 patients completed the active, treatment phase of the study, and 72 patients completed the 1-year follow-up. Patients dropped out of the study for a variety of reasons, including patients who found training painful and patients who found the brace too uncomfortable. One patient in the brace group and one patient in the training group had surgery after completing their assigned treatment.

At 54 weeks, 90% of the remaining patients reported returning to their preinjury sports activity level.

Pain during daily activities, as measured by the visual analogue scale, was reduced from pretreatment by 20% in the eccentric-training group at 6 weeks, by 41% in the brace-only group, and by 22% in the combination group. But, by week 12, there was no further reduction in pain in the AirHeel group, while the eccentric-training group had further improvement, to a 60% reduction, and the combination group had further improvement, to a 56% reduction.

At the 1-year follow-up, pain still was reduced by 30% in the eccentric-training group, 27% in the brace-only group, and 53% in the combination group.

Pain during sports at 1 year was reduced 51% in the training group, 47% in the brace-only group, and 74% in the combination group.

The braces were supplied for the study by the company (Aircast, Vista, Calif.). Dr. Petersen and his associates disclosed receiving funds for research from Aircast Europe.

A coalition that advocates for healthy pregnancies came under criticism after issuing an advisory urging pregnant women to eat more fish, based on an evidence review that received financial support from the fisheries industry.

In a statement issued Oct. 4, the National Healthy Mothers, Healthy Babies (HMHB) Coalition recommended that “women who want to become pregnant, are pregnant or are breast-feeding should eat a minimum of 12 ounces per week of fish like salmon, tuna, sardines, and mackerel, and can do so safely.”

According to the HMHB Coalition, this strategy of eating ocean fish rich in omega-3 fatty acids will ensure optimal neurologic development in children, as well as reduce the risk of preterm labor and postpartum depression in mothers.

That advice is at odds with the recommendation of the Food and Drug Administration and the Environmental Protection Agency, which in 2004 advised pregnant women and breast-feeding mothers to eat no more than 12 ounces of fish a week because of concerns about mercury exposure.

Within days after the HMHB Coalition issued its report, at least two organizations that had been listed on its Web site (www.hmhb.org

The AAP “was not pleased” to be associated with the advisory, said Dr. Frank R. Greer, chair of the AAP's nutrition committee. The academy was part of the coalition at its inception, but has not been actively involved in the organization in recent years. It “knew nothing about this statement until it was released,” said Dr. Greer, a professor of pediatrics at the University of Wisconsin, Madison.

The AAP continues to support the position that pregnant or lactating women should eat no more than 12 ounces of fish per week, he added.

The American College of Obstetricians and Gynecologists (ACOG) is a founding member of the Healthy Mothers, Healthy Babies Coalition. “However, ACOG was not involved in the development of the new recommendations. At this time, ACOG follows the FDA's recommendations on fish consumption for pregnant women,” said a spokesperson for the college.

At press time, the HMHB Coalition included more than 60 organizations, including ACOG, the Centers for Disease Control and Prevention, and the March of Dimes. The advisory and supporting documents were posted online at www.brainybabieshealthykids.org

Initial news reports about the advisory failed to mention that the coalition received funding from the National Fisheries Institute, including $14,000 for travel expenses for the Maternal Nutrition Group—a group of experts convened by the coalition—to meet and review evidence, and $60,000 to publicize the findings.

After the funding issue came to light, the coalition responded to criticism by placing a disclaimer on its Web site saying that “any statement that is supported by the HMHB Board in no way implies that it has been endorsed by our member organizations.”

The coalition maintains that the funding source did not influence the opinion of its expert group, which was led by Dr. James A. McGregor, a visiting professor of clinical obstetrics and gynecology at the University of Southern California, Los Angeles.

“If you read the articles [that the Maternal Nutrition Group reviewed], you would come to the same conclusion,” Dr. McGregor said in an interview. None of the supporting research studies were sponsored by the fisheries industry, he added.

Even before the potential conflict of interest came to light, some obstetricians said they weren't putting great stock in the suggestion.

“I would not use this recommendation to make any radical change in diet,” said Dr. E. Albert Reece, a specialist in maternal-fetal medicine who is Vice President for Medical Affairs at the University of Maryland, Distinguished Professor, and dean of the school of medicine in Baltimore.

The HMHB Coalition said that it made the recommendation because studies show that women in the United States do not consume enough fish, and that the FDA advisory warning women about mercury contamination has further discouraged consumption.

Data from the National Health and Nutrition Examination Survey show that 90% of women are eating less than the amount of fish recommended as an upper limit by the FDA, the group noted.

Further, a study by Dr. William Goodnight of the Medical University of South Carolina, Charleston, found that of the pregnant women who were aware of the FDA's advisory to limit fish intake during pregnancy, 56% reduced their fish intake well below beneficial amounts.

A survey conducted by the HMHB Coalition found that 53% of women pregnant for the first time ate less fish during pregnancy because of the warnings about mercury.

Oily ocean fish are the major source of long-chain omega-3 fatty acids, such as eicosapentaenoic acid and docosahexa- enoic acid, nutrients that are essential for fetal nervous system development. In rapid fetal growth, these fats are not synthesized by the human body in adequate amounts.

Inorganic mercury is a known neurotoxin that accumulates in fish, particularly large predator fish. In a well-documented incident in Minamata, Japan, which came to light in the 1950s, babies exposed to very high levels of mercury when their mothers ate contaminated fish developed brain damage and severe cerebral palsy.

But the question remains whether the benefits of long-chain omega-3 fatty acids might outweigh the risks of eating fish containing a lower level of mercury. (See box.)

Dr. Reece said it is possible for people who are worried about mercury or cannot eat fish to get omega-3 fatty acids from fish oil supplements. However, in its advisory, the HMHB Coalition said “consumption of ocean fish rather than ingestion of fish oil supplements is the best.”

Many pregnant women have reduced their fish intake well below beneficial amounts. Vivian E. Lee/Elsevier Global Medical News

Researchers Net Conflicting Evidence on Mercury Risks

The Maternal Nutrition Group considered evidence that includes a growing body of literature indicating that the selenium present in fish flesh may counteract the potential negative impact of mercury exposure, and that omega-3 fatty acids may help prevent preterm delivery and postpartum depression.

The group also took into account a recent study of about 8,000 British mothers and their children. That study asked the women about their fish intake while they were pregnant, and then followed the children until they were up to 8 years of age.

The study reported that children of mothers who ate less fish were more likely to have suboptimal cognitive and developmental outcomes (Lancet 2007;369:578–85). The largest difference was in the scores on a verbal intelligence test, with only 16% of the 1,330 children of mothers who ate more than 12 ounces of fish per week scoring in the lowest quartile, compared with 31% of the 584 children of mothers who ate none. About 24% of the children whose mothers ate between 0 and 12 ounces scored in the lowest quartile.

The study also found a positive impact from fish consumption in the areas of prosocial, social, and fine motor development.

In a recent article on pregnancy and lactation unrelated to the coalition's new recommendation, Dr. Gideon Koren, of the University of Toronto, reviewed some of the evidence regarding mercury exposure from fish. He noted two studies.

One was conducted in the Seychelles Islands, where the usual diet contains about 10 times more ocean fish than does the average U.S. diet. The researchers set out to see if mercury exposure hurt neurologic development. Contrary to their expectations, they found that when they measured mercury levels in hair samples from the mothers and subjected the children to sophisticated testing, children with the highest mercury exposure tended to have the best scores on many measures of development at 66 months of age.

They speculated that perhaps the beneficial effects of fish consumption exceeded the possible detrimental effects of being exposed to mercury (JAMA 1998;280:701–7).

Subsequent follow-up has not shown that any difference in development was sustained, however.

The second study was conducted in the Faroe Islands, where individuals eat pilot whale, a species with high mercury levels. Those investigators did not find any mercury-associated clinical or neurophysiologic abnormalities in about 900 children at 7 years of age. But they did find some subtle reductions in neurologic function in the children with the highest exposures (Neurotoxicol. Teratol. 1997;19:417–28).

Those investigators subsequently found that electrical signaling in the brains of those with more mercury exposure appears to be somewhat delayed at age 14 years, suggesting that the effect of mercury may be irreversible. They found delayed signaling even in children exposed to amounts of mercury lower than the FDA limits.

“This new statement [by the HMHB Coalition] only adds to the confusion,” said Dr. Philippe Grandjean, of the Harvard School of Public Health, Boston, who conducted the Faroe Islands study.

The coalition's advisory is too simple, he said. People should eat fish every week. But they probably should avoid the types of fish known to contain higher levels of mercury, such as tuna, swordfish, and shark. Safer fish are flounder, cod, mackerel, and salmon.

“Some people think that a pollution scare will prevent people from eating fish,” he said. “I don't think so. The problem, rather, is that the FDA does almost no mercury testing, and it is almost impossible for the average consumer to obtain information on which types of seafood are high in mercury.”

A coalition that advocates for healthy pregnancies came under criticism after issuing an advisory urging pregnant women to eat more fish, based on an evidence review that received financial support from the fisheries industry.

In a statement issued Oct. 4, the National Healthy Mothers, Healthy Babies (HMHB) Coalition recommended that “women who want to become pregnant, are pregnant or are breast-feeding should eat a minimum of 12 ounces per week of fish like salmon, tuna, sardines, and mackerel, and can do so safely.”

According to the HMHB Coalition, this strategy of eating ocean fish rich in omega-3 fatty acids will ensure optimal neurologic development in children, as well as reduce the risk of preterm labor and postpartum depression in mothers.

That advice is at odds with the recommendation of the Food and Drug Administration and the Environmental Protection Agency, which in 2004 advised pregnant women and breast-feeding mothers to eat no more than 12 ounces of fish a week because of concerns about mercury exposure.

Within days after the HMHB Coalition issued its report, at least two organizations that had been listed on its Web site (www.hmhb.org

The AAP “was not pleased” to be associated with the advisory, said Dr. Frank R. Greer, chair of the AAP's nutrition committee. The academy was part of the coalition at its inception, but has not been actively involved in the organization in recent years. It “knew nothing about this statement until it was released,” said Dr. Greer, a professor of pediatrics at the University of Wisconsin, Madison.

The AAP continues to support the position that pregnant or lactating women should eat no more than 12 ounces of fish per week, he added.

The American College of Obstetricians and Gynecologists (ACOG) is a founding member of the Healthy Mothers, Healthy Babies Coalition. “However, ACOG was not involved in the development of the new recommendations. At this time, ACOG follows the FDA's recommendations on fish consumption for pregnant women,” said a spokesperson for the college.

At press time, the HMHB Coalition included more than 60 organizations, including ACOG, the Centers for Disease Control and Prevention, and the March of Dimes. The advisory and supporting documents were posted online at www.brainybabieshealthykids.org

Initial news reports about the advisory failed to mention that the coalition received funding from the National Fisheries Institute, including $14,000 for travel expenses for the Maternal Nutrition Group—a group of experts convened by the coalition—to meet and review evidence, and $60,000 to publicize the findings.

After the funding issue came to light, the coalition responded to criticism by placing a disclaimer on its Web site saying that “any statement that is supported by the HMHB Board in no way implies that it has been endorsed by our member organizations.”

The coalition maintains that the funding source did not influence the opinion of its expert group, which was led by Dr. James A. McGregor, a visiting professor of clinical obstetrics and gynecology at the University of Southern California, Los Angeles.

“If you read the articles [that the Maternal Nutrition Group reviewed], you would come to the same conclusion,” Dr. McGregor said in an interview. None of the supporting research studies were sponsored by the fisheries industry, he added.

Even before the potential conflict of interest came to light, some obstetricians said they weren't putting great stock in the suggestion.

“I would not use this recommendation to make any radical change in diet,” said Dr. E. Albert Reece, a specialist in maternal-fetal medicine who is Vice President for Medical Affairs at the University of Maryland, Distinguished Professor, and dean of the school of medicine in Baltimore.

The HMHB Coalition said that it made the recommendation because studies show that women in the United States do not consume enough fish, and that the FDA advisory warning women about mercury contamination has further discouraged consumption.

Data from the National Health and Nutrition Examination Survey show that 90% of women are eating less than the amount of fish recommended as an upper limit by the FDA, the group noted.

Further, a study by Dr. William Goodnight of the Medical University of South Carolina, Charleston, found that of the pregnant women who were aware of the FDA's advisory to limit fish intake during pregnancy, 56% reduced their fish intake well below beneficial amounts.

A survey conducted by the HMHB Coalition found that 53% of women pregnant for the first time ate less fish during pregnancy because of the warnings about mercury.

Oily ocean fish are the major source of long-chain omega-3 fatty acids, such as eicosapentaenoic acid and docosahexa- enoic acid, nutrients that are essential for fetal nervous system development. In rapid fetal growth, these fats are not synthesized by the human body in adequate amounts.

Inorganic mercury is a known neurotoxin that accumulates in fish, particularly large predator fish. In a well-documented incident in Minamata, Japan, which came to light in the 1950s, babies exposed to very high levels of mercury when their mothers ate contaminated fish developed brain damage and severe cerebral palsy.

But the question remains whether the benefits of long-chain omega-3 fatty acids might outweigh the risks of eating fish containing a lower level of mercury. (See box.)

Dr. Reece said it is possible for people who are worried about mercury or cannot eat fish to get omega-3 fatty acids from fish oil supplements. However, in its advisory, the HMHB Coalition said “consumption of ocean fish rather than ingestion of fish oil supplements is the best.”

Many pregnant women have reduced their fish intake well below beneficial amounts. Vivian E. Lee/Elsevier Global Medical News

Researchers Net Conflicting Evidence on Mercury Risks

The Maternal Nutrition Group considered evidence that includes a growing body of literature indicating that the selenium present in fish flesh may counteract the potential negative impact of mercury exposure, and that omega-3 fatty acids may help prevent preterm delivery and postpartum depression.

The group also took into account a recent study of about 8,000 British mothers and their children. That study asked the women about their fish intake while they were pregnant, and then followed the children until they were up to 8 years of age.

The study reported that children of mothers who ate less fish were more likely to have suboptimal cognitive and developmental outcomes (Lancet 2007;369:578–85). The largest difference was in the scores on a verbal intelligence test, with only 16% of the 1,330 children of mothers who ate more than 12 ounces of fish per week scoring in the lowest quartile, compared with 31% of the 584 children of mothers who ate none. About 24% of the children whose mothers ate between 0 and 12 ounces scored in the lowest quartile.

The study also found a positive impact from fish consumption in the areas of prosocial, social, and fine motor development.

In a recent article on pregnancy and lactation unrelated to the coalition's new recommendation, Dr. Gideon Koren, of the University of Toronto, reviewed some of the evidence regarding mercury exposure from fish. He noted two studies.

One was conducted in the Seychelles Islands, where the usual diet contains about 10 times more ocean fish than does the average U.S. diet. The researchers set out to see if mercury exposure hurt neurologic development. Contrary to their expectations, they found that when they measured mercury levels in hair samples from the mothers and subjected the children to sophisticated testing, children with the highest mercury exposure tended to have the best scores on many measures of development at 66 months of age.

They speculated that perhaps the beneficial effects of fish consumption exceeded the possible detrimental effects of being exposed to mercury (JAMA 1998;280:701–7).

Subsequent follow-up has not shown that any difference in development was sustained, however.

The second study was conducted in the Faroe Islands, where individuals eat pilot whale, a species with high mercury levels. Those investigators did not find any mercury-associated clinical or neurophysiologic abnormalities in about 900 children at 7 years of age. But they did find some subtle reductions in neurologic function in the children with the highest exposures (Neurotoxicol. Teratol. 1997;19:417–28).

Those investigators subsequently found that electrical signaling in the brains of those with more mercury exposure appears to be somewhat delayed at age 14 years, suggesting that the effect of mercury may be irreversible. They found delayed signaling even in children exposed to amounts of mercury lower than the FDA limits.

“This new statement [by the HMHB Coalition] only adds to the confusion,” said Dr. Philippe Grandjean, of the Harvard School of Public Health, Boston, who conducted the Faroe Islands study.

The coalition's advisory is too simple, he said. People should eat fish every week. But they probably should avoid the types of fish known to contain higher levels of mercury, such as tuna, swordfish, and shark. Safer fish are flounder, cod, mackerel, and salmon.

“Some people think that a pollution scare will prevent people from eating fish,” he said. “I don't think so. The problem, rather, is that the FDA does almost no mercury testing, and it is almost impossible for the average consumer to obtain information on which types of seafood are high in mercury.”

A coalition that advocates for healthy pregnancies came under criticism after issuing an advisory urging pregnant women to eat more fish, based on an evidence review that received financial support from the fisheries industry.

In a statement issued Oct. 4, the National Healthy Mothers, Healthy Babies (HMHB) Coalition recommended that “women who want to become pregnant, are pregnant or are breast-feeding should eat a minimum of 12 ounces per week of fish like salmon, tuna, sardines, and mackerel, and can do so safely.”

According to the HMHB Coalition, this strategy of eating ocean fish rich in omega-3 fatty acids will ensure optimal neurologic development in children, as well as reduce the risk of preterm labor and postpartum depression in mothers.

That advice is at odds with the recommendation of the Food and Drug Administration and the Environmental Protection Agency, which in 2004 advised pregnant women and breast-feeding mothers to eat no more than 12 ounces of fish a week because of concerns about mercury exposure.

Within days after the HMHB Coalition issued its report, at least two organizations that had been listed on its Web site (www.hmhb.org

The AAP “was not pleased” to be associated with the advisory, said Dr. Frank R. Greer, chair of the AAP's nutrition committee. The academy was part of the coalition at its inception, but has not been actively involved in the organization in recent years. It “knew nothing about this statement until it was released,” said Dr. Greer, a professor of pediatrics at the University of Wisconsin, Madison.

The AAP continues to support the position that pregnant or lactating women should eat no more than 12 ounces of fish per week, he added.

The American College of Obstetricians and Gynecologists (ACOG) is a founding member of the Healthy Mothers, Healthy Babies Coalition. “However, ACOG was not involved in the development of the new recommendations. At this time, ACOG follows the FDA's recommendations on fish consumption for pregnant women,” said a spokesperson for the college.

At press time, the HMHB Coalition included more than 60 organizations, including ACOG, the Centers for Disease Control and Prevention, and the March of Dimes. The advisory and supporting documents were posted online at www.brainybabieshealthykids.org

Initial news reports about the advisory failed to mention that the coalition received funding from the National Fisheries Institute, including $14,000 for travel expenses for the Maternal Nutrition Group—a group of experts convened by the coalition—to meet and review evidence, and $60,000 to publicize the findings.

After the funding issue came to light, the coalition responded to criticism by placing a disclaimer on its Web site saying that “any statement that is supported by the HMHB Board in no way implies that it has been endorsed by our member organizations.”

The coalition maintains that the funding source did not influence the opinion of its expert group, which was led by Dr. James A. McGregor, a visiting professor of clinical obstetrics and gynecology at the University of Southern California, Los Angeles.

“If you read the articles [that the Maternal Nutrition Group reviewed], you would come to the same conclusion,” Dr. McGregor said in an interview. None of the supporting research studies were sponsored by the fisheries industry, he added.

Even before the potential conflict of interest came to light, some obstetricians said they weren't putting great stock in the suggestion.

“I would not use this recommendation to make any radical change in diet,” said Dr. E. Albert Reece, a specialist in maternal-fetal medicine who is Vice President for Medical Affairs at the University of Maryland, Distinguished Professor, and dean of the school of medicine in Baltimore.

The HMHB Coalition said that it made the recommendation because studies show that women in the United States do not consume enough fish, and that the FDA advisory warning women about mercury contamination has further discouraged consumption.

Data from the National Health and Nutrition Examination Survey show that 90% of women are eating less than the amount of fish recommended as an upper limit by the FDA, the group noted.

Further, a study by Dr. William Goodnight of the Medical University of South Carolina, Charleston, found that of the pregnant women who were aware of the FDA's advisory to limit fish intake during pregnancy, 56% reduced their fish intake well below beneficial amounts.

A survey conducted by the HMHB Coalition found that 53% of women pregnant for the first time ate less fish during pregnancy because of the warnings about mercury.

Oily ocean fish are the major source of long-chain omega-3 fatty acids, such as eicosapentaenoic acid and docosahexa- enoic acid, nutrients that are essential for fetal nervous system development. In rapid fetal growth, these fats are not synthesized by the human body in adequate amounts.

Inorganic mercury is a known neurotoxin that accumulates in fish, particularly large predator fish. In a well-documented incident in Minamata, Japan, which came to light in the 1950s, babies exposed to very high levels of mercury when their mothers ate contaminated fish developed brain damage and severe cerebral palsy.

But the question remains whether the benefits of long-chain omega-3 fatty acids might outweigh the risks of eating fish containing a lower level of mercury. (See box.)

Dr. Reece said it is possible for people who are worried about mercury or cannot eat fish to get omega-3 fatty acids from fish oil supplements. However, in its advisory, the HMHB Coalition said “consumption of ocean fish rather than ingestion of fish oil supplements is the best.”

Many pregnant women have reduced their fish intake well below beneficial amounts. Vivian E. Lee/Elsevier Global Medical News

Researchers Net Conflicting Evidence on Mercury Risks

The Maternal Nutrition Group considered evidence that includes a growing body of literature indicating that the selenium present in fish flesh may counteract the potential negative impact of mercury exposure, and that omega-3 fatty acids may help prevent preterm delivery and postpartum depression.

The group also took into account a recent study of about 8,000 British mothers and their children. That study asked the women about their fish intake while they were pregnant, and then followed the children until they were up to 8 years of age.

The study reported that children of mothers who ate less fish were more likely to have suboptimal cognitive and developmental outcomes (Lancet 2007;369:578–85). The largest difference was in the scores on a verbal intelligence test, with only 16% of the 1,330 children of mothers who ate more than 12 ounces of fish per week scoring in the lowest quartile, compared with 31% of the 584 children of mothers who ate none. About 24% of the children whose mothers ate between 0 and 12 ounces scored in the lowest quartile.

The study also found a positive impact from fish consumption in the areas of prosocial, social, and fine motor development.

In a recent article on pregnancy and lactation unrelated to the coalition's new recommendation, Dr. Gideon Koren, of the University of Toronto, reviewed some of the evidence regarding mercury exposure from fish. He noted two studies.

One was conducted in the Seychelles Islands, where the usual diet contains about 10 times more ocean fish than does the average U.S. diet. The researchers set out to see if mercury exposure hurt neurologic development. Contrary to their expectations, they found that when they measured mercury levels in hair samples from the mothers and subjected the children to sophisticated testing, children with the highest mercury exposure tended to have the best scores on many measures of development at 66 months of age.

They speculated that perhaps the beneficial effects of fish consumption exceeded the possible detrimental effects of being exposed to mercury (JAMA 1998;280:701–7).

Subsequent follow-up has not shown that any difference in development was sustained, however.

The second study was conducted in the Faroe Islands, where individuals eat pilot whale, a species with high mercury levels. Those investigators did not find any mercury-associated clinical or neurophysiologic abnormalities in about 900 children at 7 years of age. But they did find some subtle reductions in neurologic function in the children with the highest exposures (Neurotoxicol. Teratol. 1997;19:417–28).

Those investigators subsequently found that electrical signaling in the brains of those with more mercury exposure appears to be somewhat delayed at age 14 years, suggesting that the effect of mercury may be irreversible. They found delayed signaling even in children exposed to amounts of mercury lower than the FDA limits.

“This new statement [by the HMHB Coalition] only adds to the confusion,” said Dr. Philippe Grandjean, of the Harvard School of Public Health, Boston, who conducted the Faroe Islands study.

The coalition's advisory is too simple, he said. People should eat fish every week. But they probably should avoid the types of fish known to contain higher levels of mercury, such as tuna, swordfish, and shark. Safer fish are flounder, cod, mackerel, and salmon.

“Some people think that a pollution scare will prevent people from eating fish,” he said. “I don't think so. The problem, rather, is that the FDA does almost no mercury testing, and it is almost impossible for the average consumer to obtain information on which types of seafood are high in mercury.”