Mary Ellen Schneider

RENO, NEV. — Efforts to prevent childhood obesity should start before children enter school, Leann Birch, Ph.D., said at the annual meeting of the American College of Nutrition.

“If we wait until kids start school, we miss our best chance to prevent obesity,” said Dr. Birch, director of the Center for Childhood Obesity Research at the Pennsylvania State University, University Park.

A recent review of a number of obesity interventions conducted in school settings showed that only about half produced any type of change in eating behaviors, physical activity, or body mass index, and that the effect sizes were too small to keep up with projected and current population increases in childhood obesity. In addition, the largest and most rigorous studies were not successful.

“It suggests that we really need some other kinds of approaches,” Dr. Birch said.

The school setting is a logical place to conduct an obesity intervention, Dr. Birch said, because that's where the children are and there's an opportunity to teach them about nutrition and physical activity. However, the successful implementation of a program can be challenging because schools have other priorities and institutional change there is often difficult.

Current figures show that by the time children start school, about 20% are already overweight, and that number is even higher among high-risk groups, Dr. Birch said. By the time children are 5 years old, they have already learned an enormous amount about food and eating. They've eaten more than 10,000 meals and snacks, watched thousands of hours of television, and have seen thousands of food commercials, she said.

There are a number of environmental influences that contribute to childhood obesity, but parents can have a substantial effect on their young children, Dr. Birch said. The literature on the risk factors for childhood obesity indicates that parental choices play a significant role. For example, risk factors for childhood obesity include formula feeding; the early introduction of solid foods; too much time spent watching television; and parental overweight and activity levels.

One promising area for intervention is increasing the exclusive practice of breast-feeding, Dr. Birch said. Her own research suggests that breast-feeding could help to improve a child's acceptance of foods later on. In an experiment that looked at the effects of repeated exposures to food, Dr. Birch and her colleagues found that infants were more accepting of food after repeated exposures and that breast-fed infants were more accepting than were formula-fed infants (Pediatrics 1994;93:271–7).

It's possible that the early exposure to flavors in the mother's breast milk helps infants in accepting new flavors in their diets as they move on to solid foods, she said.

Parental perceptions about weight are another area in which work is needed, she said. Studies in general have shown that about one-third of obese children (those above the 95th percentile for their age and gender) are classified as normal weight by their parents. This misclassification is more common among less-educated and low-income mothers. “These kinds of perceptions are real barriers to pediatricians' broaching the topic and having a meaningful discussion with parents,” Dr. Birch said.

New approaches are needed to help parents understand that the provision of too much food and childhood overweight are threats to a child's healthy development, she said. In a study designed to see how much children would eat when given double the age-appropriate portion size, Dr. Birch and her colleagues found that children ate about 25% more when they were given larger portions compared with age-appropriate amounts (Am. J. Clin. Nutr. 2003;77:1164–70).

But food restriction won't work to curb this problem, Dr. Birch said, because it makes the food even more attractive to children. Research shows that mothers who used restrictive feeding practices had daughters who ate more in the absence of hunger (Am. J. Clin. Nutr. 2003;78:215–20).

Instead, Dr. Birch suggests parents start early and give children a chance to try healthy foods repeatedly. Healthy food should also be presented in a positive context and children shouldn't be coerced into eating those foods. Parents can also serve as models in their own eating and activity choices, she said.

RENO, NEV. — Efforts to prevent childhood obesity should start before children enter school, Leann Birch, Ph.D., said at the annual meeting of the American College of Nutrition.

“If we wait until kids start school, we miss our best chance to prevent obesity,” said Dr. Birch, director of the Center for Childhood Obesity Research at the Pennsylvania State University, University Park.

A recent review of a number of obesity interventions conducted in school settings showed that only about half produced any type of change in eating behaviors, physical activity, or body mass index, and that the effect sizes were too small to keep up with projected and current population increases in childhood obesity. In addition, the largest and most rigorous studies were not successful.

“It suggests that we really need some other kinds of approaches,” Dr. Birch said.

The school setting is a logical place to conduct an obesity intervention, Dr. Birch said, because that's where the children are and there's an opportunity to teach them about nutrition and physical activity. However, the successful implementation of a program can be challenging because schools have other priorities and institutional change there is often difficult.

Current figures show that by the time children start school, about 20% are already overweight, and that number is even higher among high-risk groups, Dr. Birch said. By the time children are 5 years old, they have already learned an enormous amount about food and eating. They've eaten more than 10,000 meals and snacks, watched thousands of hours of television, and have seen thousands of food commercials, she said.

There are a number of environmental influences that contribute to childhood obesity, but parents can have a substantial effect on their young children, Dr. Birch said. The literature on the risk factors for childhood obesity indicates that parental choices play a significant role. For example, risk factors for childhood obesity include formula feeding; the early introduction of solid foods; too much time spent watching television; and parental overweight and activity levels.

One promising area for intervention is increasing the exclusive practice of breast-feeding, Dr. Birch said. Her own research suggests that breast-feeding could help to improve a child's acceptance of foods later on. In an experiment that looked at the effects of repeated exposures to food, Dr. Birch and her colleagues found that infants were more accepting of food after repeated exposures and that breast-fed infants were more accepting than were formula-fed infants (Pediatrics 1994;93:271–7).

It's possible that the early exposure to flavors in the mother's breast milk helps infants in accepting new flavors in their diets as they move on to solid foods, she said.

Parental perceptions about weight are another area in which work is needed, she said. Studies in general have shown that about one-third of obese children (those above the 95th percentile for their age and gender) are classified as normal weight by their parents. This misclassification is more common among less-educated and low-income mothers. “These kinds of perceptions are real barriers to pediatricians' broaching the topic and having a meaningful discussion with parents,” Dr. Birch said.

New approaches are needed to help parents understand that the provision of too much food and childhood overweight are threats to a child's healthy development, she said. In a study designed to see how much children would eat when given double the age-appropriate portion size, Dr. Birch and her colleagues found that children ate about 25% more when they were given larger portions compared with age-appropriate amounts (Am. J. Clin. Nutr. 2003;77:1164–70).

But food restriction won't work to curb this problem, Dr. Birch said, because it makes the food even more attractive to children. Research shows that mothers who used restrictive feeding practices had daughters who ate more in the absence of hunger (Am. J. Clin. Nutr. 2003;78:215–20).

Instead, Dr. Birch suggests parents start early and give children a chance to try healthy foods repeatedly. Healthy food should also be presented in a positive context and children shouldn't be coerced into eating those foods. Parents can also serve as models in their own eating and activity choices, she said.

RENO, NEV. — Efforts to prevent childhood obesity should start before children enter school, Leann Birch, Ph.D., said at the annual meeting of the American College of Nutrition.

“If we wait until kids start school, we miss our best chance to prevent obesity,” said Dr. Birch, director of the Center for Childhood Obesity Research at the Pennsylvania State University, University Park.

A recent review of a number of obesity interventions conducted in school settings showed that only about half produced any type of change in eating behaviors, physical activity, or body mass index, and that the effect sizes were too small to keep up with projected and current population increases in childhood obesity. In addition, the largest and most rigorous studies were not successful.

“It suggests that we really need some other kinds of approaches,” Dr. Birch said.

The school setting is a logical place to conduct an obesity intervention, Dr. Birch said, because that's where the children are and there's an opportunity to teach them about nutrition and physical activity. However, the successful implementation of a program can be challenging because schools have other priorities and institutional change there is often difficult.

Current figures show that by the time children start school, about 20% are already overweight, and that number is even higher among high-risk groups, Dr. Birch said. By the time children are 5 years old, they have already learned an enormous amount about food and eating. They've eaten more than 10,000 meals and snacks, watched thousands of hours of television, and have seen thousands of food commercials, she said.

There are a number of environmental influences that contribute to childhood obesity, but parents can have a substantial effect on their young children, Dr. Birch said. The literature on the risk factors for childhood obesity indicates that parental choices play a significant role. For example, risk factors for childhood obesity include formula feeding; the early introduction of solid foods; too much time spent watching television; and parental overweight and activity levels.

One promising area for intervention is increasing the exclusive practice of breast-feeding, Dr. Birch said. Her own research suggests that breast-feeding could help to improve a child's acceptance of foods later on. In an experiment that looked at the effects of repeated exposures to food, Dr. Birch and her colleagues found that infants were more accepting of food after repeated exposures and that breast-fed infants were more accepting than were formula-fed infants (Pediatrics 1994;93:271–7).

It's possible that the early exposure to flavors in the mother's breast milk helps infants in accepting new flavors in their diets as they move on to solid foods, she said.

Parental perceptions about weight are another area in which work is needed, she said. Studies in general have shown that about one-third of obese children (those above the 95th percentile for their age and gender) are classified as normal weight by their parents. This misclassification is more common among less-educated and low-income mothers. “These kinds of perceptions are real barriers to pediatricians' broaching the topic and having a meaningful discussion with parents,” Dr. Birch said.

New approaches are needed to help parents understand that the provision of too much food and childhood overweight are threats to a child's healthy development, she said. In a study designed to see how much children would eat when given double the age-appropriate portion size, Dr. Birch and her colleagues found that children ate about 25% more when they were given larger portions compared with age-appropriate amounts (Am. J. Clin. Nutr. 2003;77:1164–70).

But food restriction won't work to curb this problem, Dr. Birch said, because it makes the food even more attractive to children. Research shows that mothers who used restrictive feeding practices had daughters who ate more in the absence of hunger (Am. J. Clin. Nutr. 2003;78:215–20).

Instead, Dr. Birch suggests parents start early and give children a chance to try healthy foods repeatedly. Healthy food should also be presented in a positive context and children shouldn't be coerced into eating those foods. Parents can also serve as models in their own eating and activity choices, she said.

PHILADELPHIA — Autism-specific screening conducted at critical intervals is more effective in the early identification of autism than is using a general developmental instrument as a first-line screening technique, Dr. Susan E. Levy said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

In an investigation of 152 children aged 15–30 months, a general pediatric developmental screening tool did not adequately examine certain “red flag” characteristics or behaviors of autism that are included in autism-specific screening tools, she said.

For example, some of these red flags include when children do not babble or point, do not make meaningful gestures by age 1 year, have poor eye contact, or are losing language or social skills.

Dr. Levy, of Children's Hospital of Philadelphia, and her colleagues at the University of Pennsylvania School of Nursing, Philadelphia, compared the effectiveness of a general screening tool, the Parents' Evaluation of Developmental Status (PEDS), to an autism-specific tool, the Modified Checklist for Autism in Toddlers (M-CHAT), in screening for autism spectrum disorders in the primary care setting.

The study involved administering a general developmental screening tool first, and then an autism-specific screening of children who failed the general developmental screening tool.

The researchers enrolled 152 children with a mean age of 21 months at the Children's Hospital of Philadelphia urban pediatric primary care center and first administered the PEDS and then the M-CHAT instruments.

The results were then analyzed taking into account the two screening strategies.

The PEDS found that in 75% of the children, parents had nonsignificant concerns or no developmental or behavioral concerns.

Parents reported one or more concerns for 25% of the children. In contrast, about 14% of children in the sample scored as at risk for autism spectrum disorders through the M-CHAT, and 86% were considered not at risk.

Of the 114 children who did not have significant concerns after the PEDS, 98 (86%) passed the M-CHAT and 16 (14%) were scored as at risk for autism spectrum disorders after the M-CHAT screening tool.

Of the 38 children who had concerns noted with the PEDS, 32 (84%) passed the M-CHAT and 6 (16%) were scored as at risk with the M-CHAT.

“Children who screen negative for general developmental concerns may score positive on the M-CHAT and vice versa,” Dr. Levy said.

In this study, the Parents' Evaluation of Developmental Status screening tool did not appear to be a good substitute for the M-CHAT when screening specifically for autism spectrum disorders in a general pediatric practice in an urban setting, Dr. Levy said.

Instead, the data seems to support using an autism-specific screening tool for all children at critical ages (18 months, 24 months, and 30 months).

The children who score as having concerns on the Parents' Evaluation of Developmental Status but not on the M-CHAT may be at risk for other delays or disabilities.

These interim results are part of an ongoing study conducted by the Pennsylvania Center for Autism and Developmental Disability and Research and Epidemiology (PA-CADDRE), which is funded by the Centers for Disease Control and Prevention.

The Pennsylvania site is one of six centers around the country collaborating on projects to establish the prevalence, etiology, and risk factors of children with autism spectrum disorders, Dr. Levy said at the meeting.

PHILADELPHIA — Autism-specific screening conducted at critical intervals is more effective in the early identification of autism than is using a general developmental instrument as a first-line screening technique, Dr. Susan E. Levy said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

In an investigation of 152 children aged 15–30 months, a general pediatric developmental screening tool did not adequately examine certain “red flag” characteristics or behaviors of autism that are included in autism-specific screening tools, she said.

For example, some of these red flags include when children do not babble or point, do not make meaningful gestures by age 1 year, have poor eye contact, or are losing language or social skills.

Dr. Levy, of Children's Hospital of Philadelphia, and her colleagues at the University of Pennsylvania School of Nursing, Philadelphia, compared the effectiveness of a general screening tool, the Parents' Evaluation of Developmental Status (PEDS), to an autism-specific tool, the Modified Checklist for Autism in Toddlers (M-CHAT), in screening for autism spectrum disorders in the primary care setting.

The study involved administering a general developmental screening tool first, and then an autism-specific screening of children who failed the general developmental screening tool.

The researchers enrolled 152 children with a mean age of 21 months at the Children's Hospital of Philadelphia urban pediatric primary care center and first administered the PEDS and then the M-CHAT instruments.

The results were then analyzed taking into account the two screening strategies.

The PEDS found that in 75% of the children, parents had nonsignificant concerns or no developmental or behavioral concerns.

Parents reported one or more concerns for 25% of the children. In contrast, about 14% of children in the sample scored as at risk for autism spectrum disorders through the M-CHAT, and 86% were considered not at risk.

Of the 114 children who did not have significant concerns after the PEDS, 98 (86%) passed the M-CHAT and 16 (14%) were scored as at risk for autism spectrum disorders after the M-CHAT screening tool.

Of the 38 children who had concerns noted with the PEDS, 32 (84%) passed the M-CHAT and 6 (16%) were scored as at risk with the M-CHAT.

“Children who screen negative for general developmental concerns may score positive on the M-CHAT and vice versa,” Dr. Levy said.

In this study, the Parents' Evaluation of Developmental Status screening tool did not appear to be a good substitute for the M-CHAT when screening specifically for autism spectrum disorders in a general pediatric practice in an urban setting, Dr. Levy said.

Instead, the data seems to support using an autism-specific screening tool for all children at critical ages (18 months, 24 months, and 30 months).

The children who score as having concerns on the Parents' Evaluation of Developmental Status but not on the M-CHAT may be at risk for other delays or disabilities.

These interim results are part of an ongoing study conducted by the Pennsylvania Center for Autism and Developmental Disability and Research and Epidemiology (PA-CADDRE), which is funded by the Centers for Disease Control and Prevention.

The Pennsylvania site is one of six centers around the country collaborating on projects to establish the prevalence, etiology, and risk factors of children with autism spectrum disorders, Dr. Levy said at the meeting.

PHILADELPHIA — Autism-specific screening conducted at critical intervals is more effective in the early identification of autism than is using a general developmental instrument as a first-line screening technique, Dr. Susan E. Levy said at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

In an investigation of 152 children aged 15–30 months, a general pediatric developmental screening tool did not adequately examine certain “red flag” characteristics or behaviors of autism that are included in autism-specific screening tools, she said.

For example, some of these red flags include when children do not babble or point, do not make meaningful gestures by age 1 year, have poor eye contact, or are losing language or social skills.

Dr. Levy, of Children's Hospital of Philadelphia, and her colleagues at the University of Pennsylvania School of Nursing, Philadelphia, compared the effectiveness of a general screening tool, the Parents' Evaluation of Developmental Status (PEDS), to an autism-specific tool, the Modified Checklist for Autism in Toddlers (M-CHAT), in screening for autism spectrum disorders in the primary care setting.

The study involved administering a general developmental screening tool first, and then an autism-specific screening of children who failed the general developmental screening tool.

The researchers enrolled 152 children with a mean age of 21 months at the Children's Hospital of Philadelphia urban pediatric primary care center and first administered the PEDS and then the M-CHAT instruments.

The results were then analyzed taking into account the two screening strategies.

The PEDS found that in 75% of the children, parents had nonsignificant concerns or no developmental or behavioral concerns.

Parents reported one or more concerns for 25% of the children. In contrast, about 14% of children in the sample scored as at risk for autism spectrum disorders through the M-CHAT, and 86% were considered not at risk.

Of the 114 children who did not have significant concerns after the PEDS, 98 (86%) passed the M-CHAT and 16 (14%) were scored as at risk for autism spectrum disorders after the M-CHAT screening tool.

Of the 38 children who had concerns noted with the PEDS, 32 (84%) passed the M-CHAT and 6 (16%) were scored as at risk with the M-CHAT.

“Children who screen negative for general developmental concerns may score positive on the M-CHAT and vice versa,” Dr. Levy said.

In this study, the Parents' Evaluation of Developmental Status screening tool did not appear to be a good substitute for the M-CHAT when screening specifically for autism spectrum disorders in a general pediatric practice in an urban setting, Dr. Levy said.

Instead, the data seems to support using an autism-specific screening tool for all children at critical ages (18 months, 24 months, and 30 months).

The children who score as having concerns on the Parents' Evaluation of Developmental Status but not on the M-CHAT may be at risk for other delays or disabilities.

These interim results are part of an ongoing study conducted by the Pennsylvania Center for Autism and Developmental Disability and Research and Epidemiology (PA-CADDRE), which is funded by the Centers for Disease Control and Prevention.

The Pennsylvania site is one of six centers around the country collaborating on projects to establish the prevalence, etiology, and risk factors of children with autism spectrum disorders, Dr. Levy said at the meeting.

BOSTON — In the fall of 2005, the Tennessee Department of Health launched a campaign to vaccinate students in one county school system with a live attenuated intranasal influenza virus vaccine.

About 46% of the students were vaccinated, and the campaign had widespread support from physicians in the area. However, some physicians may have been overly cautious in their advice to patients, according to the results of a survey of more than 300 physicians in the county.

Rand Carpenter, D.V.M., of the Tennessee Department of Health, presented an analysis of the vaccination campaign at the annual meeting of the American Public Health Association.

As part of the campaign, donated live attenuated intranasal influenza virus vaccine was offered free to kindergarten through 12th -grade students and staff in the Knox County school system, which includes Knoxville, Tenn. The program lasted from October through December 2005. The live influenza virus vaccine was licensed in 2003 for use among healthy individuals aged 5–49 years.

Information packets about the program and consent forms were sent to parents, and health officials also set up an influenza virus vaccine hotline to answer questions from parents and physicians.

Across the county, 24,281 students (46%) were vaccinated as part of the campaign. Among school staff members, 3,626 (62%) were vaccinated, although about 60% were vaccinated with inactivated injectable influenza virus vaccine because they were older than the 49-year age limit. Students did not have the option of receiving the inactivated virus vaccine.

The highest level of vaccination was among elementary school students (56%). The vaccination levels dropped among older students, with about 45% of middle school students receiving vaccination with the live virus vaccine and 30% of high school students being vaccinated.

Health officials also designed and administered a survey for physicians in an effort to gauge physician knowledge and the type of advice being given to patients.

All 598 pediatric and adult physicians in the county received surveys and about 56% responded (337 physicians). About 80% of those who responded were aware of the campaign (268 physicians). Of those who were aware of the campaign, 73% (196 physicians) gave advice to patients regarding the live influenza virus vaccine. Of those giving advice, about 94% (185 physicians) recommended participation for eligible patients. “These results indicated that physicians were supportive of this vaccination campaign,” he said.

However, state health officials noticed that some patients were confused by their physician's advice and that some of the information given by providers potentially limited the campaign's success, Dr. Carpenter said.

Physicians gave several reasons for advising patients against participating in the vaccination program.

The most frequent reasons included having asthma, being immunocompromised or living with an immunocompromised household contact, having a chronic disease, egg allergy, or Guillain-Barré syndrome, or being pregnant or lactating or having a household contact who is pregnant or nursing, he said.

Having an immunocompromised close contact is only a consideration among caregivers for people with bone marrow transplant in the hospital settings, Dr. Carpenter said. “This category was seemingly overused.”

In addition, the live virus vaccine is not contraindicated in nursing patients and pregnant or nursing household contacts, he said.

BOSTON — In the fall of 2005, the Tennessee Department of Health launched a campaign to vaccinate students in one county school system with a live attenuated intranasal influenza virus vaccine.

About 46% of the students were vaccinated, and the campaign had widespread support from physicians in the area. However, some physicians may have been overly cautious in their advice to patients, according to the results of a survey of more than 300 physicians in the county.

Rand Carpenter, D.V.M., of the Tennessee Department of Health, presented an analysis of the vaccination campaign at the annual meeting of the American Public Health Association.

As part of the campaign, donated live attenuated intranasal influenza virus vaccine was offered free to kindergarten through 12th -grade students and staff in the Knox County school system, which includes Knoxville, Tenn. The program lasted from October through December 2005. The live influenza virus vaccine was licensed in 2003 for use among healthy individuals aged 5–49 years.

Information packets about the program and consent forms were sent to parents, and health officials also set up an influenza virus vaccine hotline to answer questions from parents and physicians.

Across the county, 24,281 students (46%) were vaccinated as part of the campaign. Among school staff members, 3,626 (62%) were vaccinated, although about 60% were vaccinated with inactivated injectable influenza virus vaccine because they were older than the 49-year age limit. Students did not have the option of receiving the inactivated virus vaccine.

The highest level of vaccination was among elementary school students (56%). The vaccination levels dropped among older students, with about 45% of middle school students receiving vaccination with the live virus vaccine and 30% of high school students being vaccinated.

Health officials also designed and administered a survey for physicians in an effort to gauge physician knowledge and the type of advice being given to patients.

All 598 pediatric and adult physicians in the county received surveys and about 56% responded (337 physicians). About 80% of those who responded were aware of the campaign (268 physicians). Of those who were aware of the campaign, 73% (196 physicians) gave advice to patients regarding the live influenza virus vaccine. Of those giving advice, about 94% (185 physicians) recommended participation for eligible patients. “These results indicated that physicians were supportive of this vaccination campaign,” he said.

However, state health officials noticed that some patients were confused by their physician's advice and that some of the information given by providers potentially limited the campaign's success, Dr. Carpenter said.

Physicians gave several reasons for advising patients against participating in the vaccination program.

The most frequent reasons included having asthma, being immunocompromised or living with an immunocompromised household contact, having a chronic disease, egg allergy, or Guillain-Barré syndrome, or being pregnant or lactating or having a household contact who is pregnant or nursing, he said.

Having an immunocompromised close contact is only a consideration among caregivers for people with bone marrow transplant in the hospital settings, Dr. Carpenter said. “This category was seemingly overused.”

In addition, the live virus vaccine is not contraindicated in nursing patients and pregnant or nursing household contacts, he said.

BOSTON — In the fall of 2005, the Tennessee Department of Health launched a campaign to vaccinate students in one county school system with a live attenuated intranasal influenza virus vaccine.

About 46% of the students were vaccinated, and the campaign had widespread support from physicians in the area. However, some physicians may have been overly cautious in their advice to patients, according to the results of a survey of more than 300 physicians in the county.

Rand Carpenter, D.V.M., of the Tennessee Department of Health, presented an analysis of the vaccination campaign at the annual meeting of the American Public Health Association.

As part of the campaign, donated live attenuated intranasal influenza virus vaccine was offered free to kindergarten through 12th -grade students and staff in the Knox County school system, which includes Knoxville, Tenn. The program lasted from October through December 2005. The live influenza virus vaccine was licensed in 2003 for use among healthy individuals aged 5–49 years.

Information packets about the program and consent forms were sent to parents, and health officials also set up an influenza virus vaccine hotline to answer questions from parents and physicians.

Across the county, 24,281 students (46%) were vaccinated as part of the campaign. Among school staff members, 3,626 (62%) were vaccinated, although about 60% were vaccinated with inactivated injectable influenza virus vaccine because they were older than the 49-year age limit. Students did not have the option of receiving the inactivated virus vaccine.

The highest level of vaccination was among elementary school students (56%). The vaccination levels dropped among older students, with about 45% of middle school students receiving vaccination with the live virus vaccine and 30% of high school students being vaccinated.

Health officials also designed and administered a survey for physicians in an effort to gauge physician knowledge and the type of advice being given to patients.

All 598 pediatric and adult physicians in the county received surveys and about 56% responded (337 physicians). About 80% of those who responded were aware of the campaign (268 physicians). Of those who were aware of the campaign, 73% (196 physicians) gave advice to patients regarding the live influenza virus vaccine. Of those giving advice, about 94% (185 physicians) recommended participation for eligible patients. “These results indicated that physicians were supportive of this vaccination campaign,” he said.

However, state health officials noticed that some patients were confused by their physician's advice and that some of the information given by providers potentially limited the campaign's success, Dr. Carpenter said.

Physicians gave several reasons for advising patients against participating in the vaccination program.

The most frequent reasons included having asthma, being immunocompromised or living with an immunocompromised household contact, having a chronic disease, egg allergy, or Guillain-Barré syndrome, or being pregnant or lactating or having a household contact who is pregnant or nursing, he said.

Having an immunocompromised close contact is only a consideration among caregivers for people with bone marrow transplant in the hospital settings, Dr. Carpenter said. “This category was seemingly overused.”

In addition, the live virus vaccine is not contraindicated in nursing patients and pregnant or nursing household contacts, he said.

Over the last decade, health care in the Department of Veterans Affairs has transformed itself from a notorious near-failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

The award was given to seven government programs that each took a unique approach to meeting community needs. All recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, the VA is clearly doing something right when it comes to health information technology (IT). Dr. Turner, who is chief of general surgery for the VA Maryland Health Care System at the Baltimore VA Medical Center and is on the surgery faculty at the University of Maryland, Baltimore, has a foot in both the VA system and the private sector.

At the University of Maryland Medical Center, he works with at least two different computer systems for reporting patient variables, as well as consulting with electronic and paper sources to get information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier. “Everything is in the computer,” he said.

The VA computerized patient record system, which sits atop the VistA platform, includes the physician's notes, lab results, and results of consults and surgical procedures. It also generally includes information from visits made outside the system. A hard copy of the clinical record from an outside visit can be scanned into the VA system and made available within a day.

Quality of care has improved since the implementation of VistA, Dr. Turner said. The system includes a check for drug-drug interactions plus several other alerts that let the physician know what's been going on with the patient since the last visit. “Hands down, I would take the VA computer [system] anywhere,” Dr. Turner concluded.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

And the move to an electronic system was driven largely by clinicians who said they needed better tools. “We had clinicians actively saying, 'We need this, we need this, we need this,'” Ms. Fischetti said.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it. But she noted that the VA, as both the payer and provider of health care services, distinguishes itself from most U.S. care providers. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

Although the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society. For example, successful adoption of a health IT system requires buy-in from clinician leadership. Although clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are applicable as well to the small practice, Mr. Leary said, where the return may be an improvement not only in quality of care for patients, but also in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, Dr. Weaver said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

Over the last decade, health care in the Department of Veterans Affairs has transformed itself from a notorious near-failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

The award was given to seven government programs that each took a unique approach to meeting community needs. All recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, the VA is clearly doing something right when it comes to health information technology (IT). Dr. Turner, who is chief of general surgery for the VA Maryland Health Care System at the Baltimore VA Medical Center and is on the surgery faculty at the University of Maryland, Baltimore, has a foot in both the VA system and the private sector.

At the University of Maryland Medical Center, he works with at least two different computer systems for reporting patient variables, as well as consulting with electronic and paper sources to get information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier. “Everything is in the computer,” he said.

The VA computerized patient record system, which sits atop the VistA platform, includes the physician's notes, lab results, and results of consults and surgical procedures. It also generally includes information from visits made outside the system. A hard copy of the clinical record from an outside visit can be scanned into the VA system and made available within a day.

Quality of care has improved since the implementation of VistA, Dr. Turner said. The system includes a check for drug-drug interactions plus several other alerts that let the physician know what's been going on with the patient since the last visit. “Hands down, I would take the VA computer [system] anywhere,” Dr. Turner concluded.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

And the move to an electronic system was driven largely by clinicians who said they needed better tools. “We had clinicians actively saying, 'We need this, we need this, we need this,'” Ms. Fischetti said.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it. But she noted that the VA, as both the payer and provider of health care services, distinguishes itself from most U.S. care providers. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

Although the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society. For example, successful adoption of a health IT system requires buy-in from clinician leadership. Although clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are applicable as well to the small practice, Mr. Leary said, where the return may be an improvement not only in quality of care for patients, but also in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, Dr. Weaver said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

Over the last decade, health care in the Department of Veterans Affairs has transformed itself from a notorious near-failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

The award was given to seven government programs that each took a unique approach to meeting community needs. All recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, the VA is clearly doing something right when it comes to health information technology (IT). Dr. Turner, who is chief of general surgery for the VA Maryland Health Care System at the Baltimore VA Medical Center and is on the surgery faculty at the University of Maryland, Baltimore, has a foot in both the VA system and the private sector.

At the University of Maryland Medical Center, he works with at least two different computer systems for reporting patient variables, as well as consulting with electronic and paper sources to get information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier. “Everything is in the computer,” he said.

The VA computerized patient record system, which sits atop the VistA platform, includes the physician's notes, lab results, and results of consults and surgical procedures. It also generally includes information from visits made outside the system. A hard copy of the clinical record from an outside visit can be scanned into the VA system and made available within a day.

Quality of care has improved since the implementation of VistA, Dr. Turner said. The system includes a check for drug-drug interactions plus several other alerts that let the physician know what's been going on with the patient since the last visit. “Hands down, I would take the VA computer [system] anywhere,” Dr. Turner concluded.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

And the move to an electronic system was driven largely by clinicians who said they needed better tools. “We had clinicians actively saying, 'We need this, we need this, we need this,'” Ms. Fischetti said.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it. But she noted that the VA, as both the payer and provider of health care services, distinguishes itself from most U.S. care providers. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

Although the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society. For example, successful adoption of a health IT system requires buy-in from clinician leadership. Although clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are applicable as well to the small practice, Mr. Leary said, where the return may be an improvement not only in quality of care for patients, but also in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, Dr. Weaver said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

Over the last decade, health care within the Department of Veterans Affairs has transformed itself from a notorious near failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

The move was driven largely by clinicians who said they needed better tools.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation, and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it.

She noted, however, that the VA, as both the payer and provider of health care services, distinguishes itself from most of the care providers in the United States. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

While the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society.

For example, successful adoption of a health IT system requires buy-in from clinician leadership. While clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost effectiveness of care—as seen in VistA.

These ideas also are applicable in the small practice, Mr. Leary said, where the return also may be in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

Over the last decade, health care within the Department of Veterans Affairs has transformed itself from a notorious near failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

The move was driven largely by clinicians who said they needed better tools.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation, and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it.

She noted, however, that the VA, as both the payer and provider of health care services, distinguishes itself from most of the care providers in the United States. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

While the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society.

For example, successful adoption of a health IT system requires buy-in from clinician leadership. While clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost effectiveness of care—as seen in VistA.

These ideas also are applicable in the small practice, Mr. Leary said, where the return also may be in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

Over the last decade, health care within the Department of Veterans Affairs has transformed itself from a notorious near failure to a national model for quality improvement, leaving many asking how they can incorporate those lessons.

The answer may lie in part with the department's electronic health record system. Known as VistA (Veterans Health Information Systems and Technology Architecture), the system recently received the Innovations in American Government Award—a top honor from Harvard University's Kennedy School of Government.

VA officials began building the first generation of the computerized patient record system in the late 1980s out of a need to deal with the increasing number of veterans coming into the system, while resources remained tight, said Linda Fischetti, R.N., acting chief health informatics officer at the Veterans Health Administration's Office of Information. “We had to find ways that we could reduce redundancies and care for more patients.”

The move was driven largely by clinicians who said they needed better tools.

The idea was to create a single system with robust functionality in every health care environment—the inpatient hospital, the outpatient hospital, the long-term care facility, and clinics within the community. The current system is the second generation, and VA officials continue to modernize it, Ms. Fischetti said. Today the system allows VA clinicians access to complete historical information on their patients, as well as real-time clinical reminders and real-time decision support.

The No. 1 lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. The system also needs to do more than just replace the paper chart. If the health IT product does not add value for physicians, she said, they might not adopt it.

She noted, however, that the VA, as both the payer and provider of health care services, distinguishes itself from most of the care providers in the United States. “We are definitely different because we have the alignment of the payer and provider within our own enterprise.”

While the VA is a unique system, there are lessons that can be applied in large hospital systems and even in solo physician practices, said Tom Leary, director of federal affairs at the Healthcare Information and Management Systems Society.

For example, successful adoption of a health IT system requires buy-in from clinician leadership. While clinician use of a system can be mandated to some extent in any organization, it does not produce the same results unless physicians and nurses want to use the technology, Mr. Leary said. Success also depends on getting a return on investment—improvement in quality and cost effectiveness of care—as seen in VistA.

These ideas also are applicable in the small practice, Mr. Leary said, where the return also may be in quality of life for providers. Physicians have the opportunity to provide better care, without, for example, having to drive back to the office on the weekend to answer a call about a patient, he said.

Other systems can also learn from the VA's approach to designing the system with the needs of its clinicians in mind, said Dr. Dennis Weaver, acting chief medical officer for the National Alliance for Health Information Technology. “You've got to build it for the clinicians,” he said.

But that doesn't mean just automating patient charts, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system need to resist the urge to “pave the cow path.” They must let clinicians know up front that the work flow is going to change.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials. The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

However, the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. “The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

Nevertheless, the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard. “The researchers are treated like hired hands.”

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said. “That's the combination we're getting.”

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials. The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

However, the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. “The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

Nevertheless, the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard. “The researchers are treated like hired hands.”

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said. “That's the combination we're getting.”

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials. The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said in an interview.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions. And the agency has a long to-do list of reforms aimed at promoting early detection of safety problems and improving communication with physicians and patients.

However, the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later. “The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

Nevertheless, the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard. “The researchers are treated like hired hands.”

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said. “That's the combination we're getting.”

Birth-Control Education Drops

From 1995 to 2002, there was a shift in sex education programs away from providing instruction about contraceptive methods, according to a study published in the December issue of Perspectives on Sexual and Reproductive Health. The number of adolescent males who received any formal instruction about contraceptive methods dropped from 81.2% in 1995 to 66.2% in 2002. Among adolescent females, the proportion receiving any instruction in contraceptive methods fell from 87.1% to 69.9%. In the meantime, the proportion of adolescents who reported receiving only information about abstinence as part of formal sex education programs increased between 1995 and 2002. Among males, abstinence-only education increased from 9.3% to 23.8%, and it increased from 7.6% to 20.7% among females. Researchers from the Guttmacher Institute and Columbia University analyzed changes in adolescent reports of sex education from formal sources such as schools, churches, and community groups. The findings are based on data from the 1995 National Survey of Adolescent Males and the 1995 and 2002 National Survey of Family Growth.

New Hampshire Has Free HPV Vaccine

New Hampshire is the first state to offer the human papillomavirus (HPV) vaccine free as part of its universal vaccine program. The vaccine, Gardasil, will be available at no cost to girls aged 11–18 years. The vaccine was licensed by the Food and Drug Administration last June and the same month the Advisory Committee on Immunization Practices recommended vaccination with Gardasil. “The HPV vaccine represents a significant step forward in protecting the health and lives of the women and girls of New Hampshire,” John Stephen, commissioner of the New Hampshire Department of Health and Human Services, said in a statement. “This represents a small victory in the battle against cancer, and we are thrilled to be able to offer this vaccine. We strongly recommend that all parents consider getting their daughters vaccinated.”

Examining Risks for Preterm Birth

Researchers at the University of Pittsburgh-affiliated Magee-Women's Research Institute are beginning a study to examine how factors such as nutrition and inflammation affect preterm birth. The study also is expected to shed light on racial disparities in preterm births. The 5-year, $2.8 million study is funded by the National Institute of Child Health and Human Development, one of the National Institutes of Health. The researchers plan to enroll 1,200 women early in their pregnancies and collect information on diet, body mass index, and weight gain during pregnancy, as well as samples of blood and nails. “Preterm birth is a complex condition and this in-depth study of nutritional status and genetics is unique,” Dr. Hyagriv Simhan, the study's principal investigator, said in a statement. “Nutrition is something that lends itself to interventions to improve health.”

Equal Access to Fertility Treatments

Physicians have an ethical obligation to provide fertility treatment to all patients, regardless of their marital status or sexual preference, according to a report from the Ethics Committee of the American Society for Reproductive Medicine. The report was published in the November issue of the journal Fertility and Sterility. The committee determined that unless the individual or individuals would be unfit parents or the clinic does not provide the desired service, there is “no sound ethical basis for licensed professionals to deny reproductive services to unmarried or homosexual persons.” Committee members examined evidence on the welfare of children raised by unmarried parents or homosexual parents and did not find evidence of harm. “Children thrive in families where they are loved and cared for; and happy families don't need to conform to any one model,” Dr. Steven Ory, ASRM president, said in a statement. “This report from the Ethics Committee emphasizes how important it is for all people to have equal access to the help they need to have children.”

Poll Split on Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Birth-Control Education Drops

From 1995 to 2002, there was a shift in sex education programs away from providing instruction about contraceptive methods, according to a study published in the December issue of Perspectives on Sexual and Reproductive Health. The number of adolescent males who received any formal instruction about contraceptive methods dropped from 81.2% in 1995 to 66.2% in 2002. Among adolescent females, the proportion receiving any instruction in contraceptive methods fell from 87.1% to 69.9%. In the meantime, the proportion of adolescents who reported receiving only information about abstinence as part of formal sex education programs increased between 1995 and 2002. Among males, abstinence-only education increased from 9.3% to 23.8%, and it increased from 7.6% to 20.7% among females. Researchers from the Guttmacher Institute and Columbia University analyzed changes in adolescent reports of sex education from formal sources such as schools, churches, and community groups. The findings are based on data from the 1995 National Survey of Adolescent Males and the 1995 and 2002 National Survey of Family Growth.

New Hampshire Has Free HPV Vaccine

New Hampshire is the first state to offer the human papillomavirus (HPV) vaccine free as part of its universal vaccine program. The vaccine, Gardasil, will be available at no cost to girls aged 11–18 years. The vaccine was licensed by the Food and Drug Administration last June and the same month the Advisory Committee on Immunization Practices recommended vaccination with Gardasil. “The HPV vaccine represents a significant step forward in protecting the health and lives of the women and girls of New Hampshire,” John Stephen, commissioner of the New Hampshire Department of Health and Human Services, said in a statement. “This represents a small victory in the battle against cancer, and we are thrilled to be able to offer this vaccine. We strongly recommend that all parents consider getting their daughters vaccinated.”

Examining Risks for Preterm Birth

Researchers at the University of Pittsburgh-affiliated Magee-Women's Research Institute are beginning a study to examine how factors such as nutrition and inflammation affect preterm birth. The study also is expected to shed light on racial disparities in preterm births. The 5-year, $2.8 million study is funded by the National Institute of Child Health and Human Development, one of the National Institutes of Health. The researchers plan to enroll 1,200 women early in their pregnancies and collect information on diet, body mass index, and weight gain during pregnancy, as well as samples of blood and nails. “Preterm birth is a complex condition and this in-depth study of nutritional status and genetics is unique,” Dr. Hyagriv Simhan, the study's principal investigator, said in a statement. “Nutrition is something that lends itself to interventions to improve health.”

Equal Access to Fertility Treatments

Physicians have an ethical obligation to provide fertility treatment to all patients, regardless of their marital status or sexual preference, according to a report from the Ethics Committee of the American Society for Reproductive Medicine. The report was published in the November issue of the journal Fertility and Sterility. The committee determined that unless the individual or individuals would be unfit parents or the clinic does not provide the desired service, there is “no sound ethical basis for licensed professionals to deny reproductive services to unmarried or homosexual persons.” Committee members examined evidence on the welfare of children raised by unmarried parents or homosexual parents and did not find evidence of harm. “Children thrive in families where they are loved and cared for; and happy families don't need to conform to any one model,” Dr. Steven Ory, ASRM president, said in a statement. “This report from the Ethics Committee emphasizes how important it is for all people to have equal access to the help they need to have children.”

Poll Split on Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Birth-Control Education Drops

From 1995 to 2002, there was a shift in sex education programs away from providing instruction about contraceptive methods, according to a study published in the December issue of Perspectives on Sexual and Reproductive Health. The number of adolescent males who received any formal instruction about contraceptive methods dropped from 81.2% in 1995 to 66.2% in 2002. Among adolescent females, the proportion receiving any instruction in contraceptive methods fell from 87.1% to 69.9%. In the meantime, the proportion of adolescents who reported receiving only information about abstinence as part of formal sex education programs increased between 1995 and 2002. Among males, abstinence-only education increased from 9.3% to 23.8%, and it increased from 7.6% to 20.7% among females. Researchers from the Guttmacher Institute and Columbia University analyzed changes in adolescent reports of sex education from formal sources such as schools, churches, and community groups. The findings are based on data from the 1995 National Survey of Adolescent Males and the 1995 and 2002 National Survey of Family Growth.

New Hampshire Has Free HPV Vaccine

New Hampshire is the first state to offer the human papillomavirus (HPV) vaccine free as part of its universal vaccine program. The vaccine, Gardasil, will be available at no cost to girls aged 11–18 years. The vaccine was licensed by the Food and Drug Administration last June and the same month the Advisory Committee on Immunization Practices recommended vaccination with Gardasil. “The HPV vaccine represents a significant step forward in protecting the health and lives of the women and girls of New Hampshire,” John Stephen, commissioner of the New Hampshire Department of Health and Human Services, said in a statement. “This represents a small victory in the battle against cancer, and we are thrilled to be able to offer this vaccine. We strongly recommend that all parents consider getting their daughters vaccinated.”

Examining Risks for Preterm Birth

Researchers at the University of Pittsburgh-affiliated Magee-Women's Research Institute are beginning a study to examine how factors such as nutrition and inflammation affect preterm birth. The study also is expected to shed light on racial disparities in preterm births. The 5-year, $2.8 million study is funded by the National Institute of Child Health and Human Development, one of the National Institutes of Health. The researchers plan to enroll 1,200 women early in their pregnancies and collect information on diet, body mass index, and weight gain during pregnancy, as well as samples of blood and nails. “Preterm birth is a complex condition and this in-depth study of nutritional status and genetics is unique,” Dr. Hyagriv Simhan, the study's principal investigator, said in a statement. “Nutrition is something that lends itself to interventions to improve health.”

Equal Access to Fertility Treatments

Physicians have an ethical obligation to provide fertility treatment to all patients, regardless of their marital status or sexual preference, according to a report from the Ethics Committee of the American Society for Reproductive Medicine. The report was published in the November issue of the journal Fertility and Sterility. The committee determined that unless the individual or individuals would be unfit parents or the clinic does not provide the desired service, there is “no sound ethical basis for licensed professionals to deny reproductive services to unmarried or homosexual persons.” Committee members examined evidence on the welfare of children raised by unmarried parents or homosexual parents and did not find evidence of harm. “Children thrive in families where they are loved and cared for; and happy families don't need to conform to any one model,” Dr. Steven Ory, ASRM president, said in a statement. “This report from the Ethics Committee emphasizes how important it is for all people to have equal access to the help they need to have children.”

Poll Split on Off-Label Use

About half of Americans said physicians should not be allowed to prescribe pharmaceuticals for unapproved uses, according to a recent

WSJ.com/Harris

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll. How people feel about stem cell research may also depend on their political affiliation. A recent survey by the Kaiser Family Foundation and the Harvard School of Public Health found that many more Democrats and Independents favor federal funding for embryonic stem cell research than do Republicans. In a national poll of 1,867 adults, the researchers found that 67% of Democrats and 61% of Independents favor broadening federal funding for stem cell research, compared with 37% of Republicans.

Expanding Autism Research

President Bush signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Conviction in ALS Fraud Case

A federal jury recently convicted a New Jersey physician and her coconspirator of defrauding patients with amyotrophic lateral sclerosis. Dr. Charlene C. DeMarco was convicted of one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering. Over the course of the trial, the prosecutors presented evidence that Dr. DeMarco, who specialized in the treatment of Lyme disease, offered treatment to ALS patients that used stem cell therapy, and that she charged families up to $35,000 for treatments that were never performed. Dr. DeMarco told four patients and their families, all of whom lived in Louisiana, that she was running an ongoing study of stem cell treatment of ALS and required an up-front fee. Dr. DeMarco is scheduled to be sentenced in April.

Alzheimer's Research Funding

Alzheimer's disease research got a boost recently when Weill Cornell Medical College in New York announced that it will establish the Appel Institute for Alzheimer's Research. The institute is funded by a donation of $15 million from Helen and Robert Appel. The new institute will focus on novel and cross-disciplinary approaches to research into Alzheimer's disease and other neurodegenerative conditions. “By employing an interdisciplinary approach to the study of this condition, researchers at the Appel Institute will be able to obtain groundbreaking insights into the physiology of the disease,” Dr. David Hajjar, vice provost and dean of the Weill Cornell Graduate School of Medical Sciences, said in a statement. “Instead of simply following existing clinical protocols, these diverse research collaborations will offer a 360-degree view of Alzheimer's—hopefully exposing its cause and eventually its cure.”

New Approaches to Epilepsy

The Epilepsy Research Foundation, a collaboration of nonprofit organizations, recently announced a total of $400,000 in grants to fund translational research for three potential epilepsy treatment approaches. One grantee will work on developing adenosine-releasing brain implants to treat temporal lobe epilepsy in rat models. Another will evaluate the benefit of huperzine A, which is derived from a Chinese herb, as an add-on therapy for patients with refractory epilepsy. The phase IIA dose-escalation study will consider the safety and tolerability of the compound and provide initial information on its effectiveness in treating seizures. The final grant will be used to fund research into the development of a galanin-based therapy for the treatment of refractory epilepsy.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published last month, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll. How people feel about stem cell research may also depend on their political affiliation. A recent survey by the Kaiser Family Foundation and the Harvard School of Public Health found that many more Democrats and Independents favor federal funding for embryonic stem cell research than do Republicans. In a national poll of 1,867 adults, the researchers found that 67% of Democrats and 61% of Independents favor broadening federal funding for stem cell research, compared with 37% of Republicans.

Expanding Autism Research

President Bush signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Conviction in ALS Fraud Case

A federal jury recently convicted a New Jersey physician and her coconspirator of defrauding patients with amyotrophic lateral sclerosis. Dr. Charlene C. DeMarco was convicted of one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering. Over the course of the trial, the prosecutors presented evidence that Dr. DeMarco, who specialized in the treatment of Lyme disease, offered treatment to ALS patients that used stem cell therapy, and that she charged families up to $35,000 for treatments that were never performed. Dr. DeMarco told four patients and their families, all of whom lived in Louisiana, that she was running an ongoing study of stem cell treatment of ALS and required an up-front fee. Dr. DeMarco is scheduled to be sentenced in April.

Alzheimer's Research Funding

Alzheimer's disease research got a boost recently when Weill Cornell Medical College in New York announced that it will establish the Appel Institute for Alzheimer's Research. The institute is funded by a donation of $15 million from Helen and Robert Appel. The new institute will focus on novel and cross-disciplinary approaches to research into Alzheimer's disease and other neurodegenerative conditions. “By employing an interdisciplinary approach to the study of this condition, researchers at the Appel Institute will be able to obtain groundbreaking insights into the physiology of the disease,” Dr. David Hajjar, vice provost and dean of the Weill Cornell Graduate School of Medical Sciences, said in a statement. “Instead of simply following existing clinical protocols, these diverse research collaborations will offer a 360-degree view of Alzheimer's—hopefully exposing its cause and eventually its cure.”

New Approaches to Epilepsy

The Epilepsy Research Foundation, a collaboration of nonprofit organizations, recently announced a total of $400,000 in grants to fund translational research for three potential epilepsy treatment approaches. One grantee will work on developing adenosine-releasing brain implants to treat temporal lobe epilepsy in rat models. Another will evaluate the benefit of huperzine A, which is derived from a Chinese herb, as an add-on therapy for patients with refractory epilepsy. The phase IIA dose-escalation study will consider the safety and tolerability of the compound and provide initial information on its effectiveness in treating seizures. The final grant will be used to fund research into the development of a galanin-based therapy for the treatment of refractory epilepsy.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published last month, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

Stem Cell Support Drops Slightly

Most of the public supports the use of human embryonic stem cells for medical research, but that support may be faltering slightly, according to a new poll from Virginia Commonwealth University. The survey, which included 1,000 adults, found that 54% of respondents favored stem cell research in 2006, down from 58% in a similar VCU poll in 2005. The number of respondents who opposed stem cell research climbed from 32% in 2005 to 37% in the recent 2006 survey. However, when asked if they would support the use of embryonic stem cells to find a treatment for themselves or a family member with Parkinson's disease or spinal cord injury, 70% of respondents said yes. Only 21% would not support the use of stem cells in that situation, according to the 2006 poll. How people feel about stem cell research may also depend on their political affiliation. A recent survey by the Kaiser Family Foundation and the Harvard School of Public Health found that many more Democrats and Independents favor federal funding for embryonic stem cell research than do Republicans. In a national poll of 1,867 adults, the researchers found that 67% of Democrats and 61% of Independents favor broadening federal funding for stem cell research, compared with 37% of Republicans.

Expanding Autism Research

President Bush signed legislation that authorizes a major expansion of autism research, education, and early detection efforts. The Combating Autism Act of 2006 (S. 843) calls for spending nearly $1 billion on activities and research related to autism spectrum disorders over the next 5 years. The new law also calls for research that would aid in developing and validating screening tools for autism spectrum disorders. “As the prevalence of autism grows, the odds are that every American will know a family who will directly benefit from the programs and research made possible by this legislation,” Jon Shestack, cofounder of Cure Autism Now, said in a statement.

Conviction in ALS Fraud Case

A federal jury recently convicted a New Jersey physician and her coconspirator of defrauding patients with amyotrophic lateral sclerosis. Dr. Charlene C. DeMarco was convicted of one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering. Over the course of the trial, the prosecutors presented evidence that Dr. DeMarco, who specialized in the treatment of Lyme disease, offered treatment to ALS patients that used stem cell therapy, and that she charged families up to $35,000 for treatments that were never performed. Dr. DeMarco told four patients and their families, all of whom lived in Louisiana, that she was running an ongoing study of stem cell treatment of ALS and required an up-front fee. Dr. DeMarco is scheduled to be sentenced in April.

Alzheimer's Research Funding

Alzheimer's disease research got a boost recently when Weill Cornell Medical College in New York announced that it will establish the Appel Institute for Alzheimer's Research. The institute is funded by a donation of $15 million from Helen and Robert Appel. The new institute will focus on novel and cross-disciplinary approaches to research into Alzheimer's disease and other neurodegenerative conditions. “By employing an interdisciplinary approach to the study of this condition, researchers at the Appel Institute will be able to obtain groundbreaking insights into the physiology of the disease,” Dr. David Hajjar, vice provost and dean of the Weill Cornell Graduate School of Medical Sciences, said in a statement. “Instead of simply following existing clinical protocols, these diverse research collaborations will offer a 360-degree view of Alzheimer's—hopefully exposing its cause and eventually its cure.”

New Approaches to Epilepsy

The Epilepsy Research Foundation, a collaboration of nonprofit organizations, recently announced a total of $400,000 in grants to fund translational research for three potential epilepsy treatment approaches. One grantee will work on developing adenosine-releasing brain implants to treat temporal lobe epilepsy in rat models. Another will evaluate the benefit of huperzine A, which is derived from a Chinese herb, as an add-on therapy for patients with refractory epilepsy. The phase IIA dose-escalation study will consider the safety and tolerability of the compound and provide initial information on its effectiveness in treating seizures. The final grant will be used to fund research into the development of a galanin-based therapy for the treatment of refractory epilepsy.

Easing Use of Experimental Drugs

The Food and Drug Administration is proposing to widen access to experimental drugs. The agency has been accused by patient advocates and some drug makers of obfuscating the criteria physicians need to seek to use investigational drugs in their patients. In 2003, an Arlington, Va.-based advocacy group, the Abigail Alliance, sued the FDA to get unfettered access to unapproved therapies. The plaintiffs were backed by a federal appeals court in May 2006, and a rehearing of the case is expected to begin in March. In the meantime, the FDA's proposed rule, published last month, said the agency was going to make it easier for physicians to access experimental therapies, and for manufacturers to make them available. In a statement, the Abigail Alliance said the FDA proposals “merely clarify their existing policies.”

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition.

In an interview, CDER's Dr. Galson agreed that there needs to be more innovation coming from pharmaceutical companies, but said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition.

In an interview, CDER's Dr. Galson agreed that there needs to be more innovation coming from pharmaceutical companies, but said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.

BOSTON — Any proposals to reform the Food and Drug Administration should meet the test that the changes would have prevented the arthritis drug Vioxx from getting to the market, Dr. David J. Graham said at the annual meeting of the American Public Health Association.

Dr. Graham, an FDA scientist who testified before Congress in 2004 about the unwillingness of FDA officials to recognize safety problems with Vioxx (rofecoxib), was among a panel of experts who called for changes at the FDA and reforms in the way that pharmaceutical companies design clinical trials.

The criticism comes on the heels of a report from the Institute of Medicine that recommends significant reforms at the FDA, including the establishment of performance goals for safety.

The FDA has been “captured” by the industry and has taken on the value system of the pharmaceutical companies, said Dr. Graham, of the FDA Office of Surveillance and Epidemiology, who was speaking as an individual and not on behalf of the agency.

FDA officials now see their jobs as getting drugs on the market as fast as possible, Dr. Graham said. “We have at FDA a lack of checks and balances.”

FDA leadership was quick to rebut those charges. The vast majority of physicians, scientists, and staff members at the FDA reject the concept that the agency is beholden to the drug industry, Dr. Steven Galson, director of the Center for Drug Evaluation and Research (CDER), said.

In light of calls for reform, FDA officials have already taken a series of steps over the last 2 years to try to improve the processes within the agency, Dr. Galson said. For example, the agency has created a new drug safety oversight board that includes individuals from the FDA and other government agencies to provide advice on drug safety issues, and it has increased the number of staff working in the postmarketing safety area. FDA officials have also redesigned the drug label so that physicians can quickly see the key information they need to make prescribing decisions.

But the biggest advances in drug safety are more likely to come from basic science advances, he said. These advances, which the FDA is trying to foster through its Critical Path Initiative, will help scientists better predict which drugs in development will run into safety problems later.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson, a clinical instructor in the department of ambulatory care and prevention at Harvard Medical School, Boston. The current system—in which physicians voluntarily report drug-related adverse events—does not work, because it's passive, he said. The FDA could instead be doing epidemiologic studies to monitor side effects in the entire population taking a drug.

Panelists also took aim at how the pharmaceutical industry designs clinical trials. Drug trials are conducted primarily to maximize return on investment to shareholders by emphasizing benefits of the drug and minimizing risks, Dr. Abramson said.

Drug companies used to simply provide financial support for studies, but they now also design the study and keep the research, said panelist Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a senior lecturer on social medicine at Harvard.

One possible way to limit the influence of pharmaceutical companies in study design would be to create an arm of the National Institutes of Health that would oversee the design of trials, Dr. Angell said, adding that such a body could be wholly or partially funded by industry. Registration of clinical trials at their inception should be a requirement to enroll human subjects, she said.

The panel also criticized the FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require a new drug to be better than existing medications on the market. This leads to approval of drugs with limited benefits and unknown risks, Dr. Angell said.

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs to treat the same condition. In Dr. Angell's opinion, any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition.

In an interview, CDER's Dr. Galson agreed that there needs to be more innovation coming from pharmaceutical companies, but said that Congress must be careful to ensure that any additional regulatory authority doesn't hamper innovation.