Mary Ellen Schneider

Over the last decade, health care within the Department of Veterans Affairs has transformed itself from a near failure to a national model for quality improvement, leaving many to ask how they could learn from 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 of the recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, it's clear that the VA is 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, straddles 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 several different electronic and paper sources to get the information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier.

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, Dr. Turner said.

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.

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 in which 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 main lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. It must also do more than replace the conventional 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.”

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.

The system's success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are also applicable 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, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system 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 near failure to a national model for quality improvement, leaving many to ask how they could learn from 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 of the recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, it's clear that the VA is 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, straddles 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 several different electronic and paper sources to get the information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier.

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, Dr. Turner said.

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.

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 in which 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 main lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. It must also do more than replace the conventional 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.”

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.

The system's success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are also applicable 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, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system 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 near failure to a national model for quality improvement, leaving many to ask how they could learn from 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 of the recipients were given a $100,000 grant to share the factors behind their success.

For Dr. Douglas J. Turner, it's clear that the VA is 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, straddles 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 several different electronic and paper sources to get the information he needs to see patients. In contrast, at the VA, every clinic is connected in the VistA system with a single patient identifier.

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, Dr. Turner said.

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.

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 in which 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 main lesson from the VA experience is that the system must be driven by the needs of the clinician, Ms. Fischetti said. It must also do more than replace the conventional 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.”

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.

The system's success also depends on getting a return on investment—improvement in quality and cost-effectiveness of care—as seen in VistA.

These ideas are also applicable 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, he said, because recreating paper processes doesn't work. Physicians and administrators who are selecting an electronic health record system 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 a lack of checks and balances.” But FDA leadership was quick to rebut those charges. The 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 had 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 better enabling the early detection of safety problems and improving communication with physicians and patients.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

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—doesn't work because it's passive, said Dr. Abramson. The FDA could instead be doing epidemiologic studies to follow the entire population of people who are taking a drug, to monitor side effects.

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 provide only 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 way to limit the influence of pharmaceutical companies in study design might 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. The registration of clinical trials at their inception should also be a requirement to enroll human subjects, she said.

The panel also was critical of a FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require the new drug to be better than existing medications on the market. This leads to the 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. Any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition, she said, adding that such a change would force companies to spend more time on innovative drugs and less time developing “me too” products.

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

Congress will also have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The law, originally passed in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

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 a lack of checks and balances.” But FDA leadership was quick to rebut those charges. The 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 had 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 better enabling the early detection of safety problems and improving communication with physicians and patients.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

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—doesn't work because it's passive, said Dr. Abramson. The FDA could instead be doing epidemiologic studies to follow the entire population of people who are taking a drug, to monitor side effects.

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 provide only 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 way to limit the influence of pharmaceutical companies in study design might 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. The registration of clinical trials at their inception should also be a requirement to enroll human subjects, she said.

The panel also was critical of a FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require the new drug to be better than existing medications on the market. This leads to the 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. Any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition, she said, adding that such a change would force companies to spend more time on innovative drugs and less time developing “me too” products.

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

Congress will also have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The law, originally passed in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

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 a lack of checks and balances.” But FDA leadership was quick to rebut those charges. The 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 had 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 better enabling the early detection of safety problems and improving communication with physicians and patients.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

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—doesn't work because it's passive, said Dr. Abramson. The FDA could instead be doing epidemiologic studies to follow the entire population of people who are taking a drug, to monitor side effects.

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 provide only 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 way to limit the influence of pharmaceutical companies in study design might 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. The registration of clinical trials at their inception should also be a requirement to enroll human subjects, she said.

The panel also was critical of a FDA statute that requires new drugs to show effectiveness compared with placebo, but does not require the new drug to be better than existing medications on the market. This leads to the 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. Any FDA reform should require that approval of a new drug be based on comparison with existing medications to treat the same condition, she said, adding that such a change would force companies to spend more time on innovative drugs and less time developing “me too” products.

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

Congress will also have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The law, originally passed in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

NEW ORLEANS — Women in their 30s with unexplained infertility do not achieve higher live birth rates when treated with unstimulated intrauterine insemination or clomiphene, compared with expectant management, according to results of a study presented at the annual meeting of the American Society for Reproductive Medicine.

The findings suggest that in some groups of women with unexplained infertility, the option of no treatment may be as effective as treatment with clomiphene or unstimulated intrauterine insemination (IUI) in achieving a live birth, said Professor Siladitya Bhattacharya of the University of Aberdeen (Scotland) on behalf of the Scottish Unexplained Infertility Trial Collaborative Group.

“This really is the largest trial on the subject so far,” Dr. Bhattacharya said in an interview. The result “does not surprise me at all, because the effectiveness of some treatments is based on tradition rather than empirical evidence,” he added.

The study evaluated couples at five centers in Scotland who had experienced infertility for at least 2 years and who had confirmed ovulation, patent fallopian tubes, and motile sperm. Most participants in the study had primary infertility. The three randomized groups included 193 women in the expectant management group, 194 women who received 50 mg clomiphene on days 2–6 of a cycle, and 193 women who underwent unstimulated IUI over a period of 6 months. Patients in the treatment arms received up to six cycles of treatment.

Median female age, median body mass index, duration of infertility, and percentage with primary infertility were all similar among the different groups. No significant difference in sperm concentration or sperm motility was seen among the groups.

Based on available follow-up data at 16 months, the rate of live births was similar in the three groups. Thirty-three (17%) of the women in the expectant management group, 26 (14%) in the clomiphene group, and 43 (23%) in the IUI group achieved a live birth. Although significantly more women achieved a live birth in the IUI group, compared with the clomiphene group, neither active treatment was superior when compared with expectant management.

Dr. Bhattacharya said that providers tend to ignore the chance of a spontaneous pregnancy occurring in a general population of couples seeking infertility treatment. “This study highlights the potential for spontaneous pregnancy,” he said.

Some women probably do benefit from in vitro fertilization (IVF). “[For] those who have tried for a reasonable time and in whom age is an issue, we should think about IVF sooner,” he said.

NEW ORLEANS — Women in their 30s with unexplained infertility do not achieve higher live birth rates when treated with unstimulated intrauterine insemination or clomiphene, compared with expectant management, according to results of a study presented at the annual meeting of the American Society for Reproductive Medicine.

The findings suggest that in some groups of women with unexplained infertility, the option of no treatment may be as effective as treatment with clomiphene or unstimulated intrauterine insemination (IUI) in achieving a live birth, said Professor Siladitya Bhattacharya of the University of Aberdeen (Scotland) on behalf of the Scottish Unexplained Infertility Trial Collaborative Group.

“This really is the largest trial on the subject so far,” Dr. Bhattacharya said in an interview. The result “does not surprise me at all, because the effectiveness of some treatments is based on tradition rather than empirical evidence,” he added.

The study evaluated couples at five centers in Scotland who had experienced infertility for at least 2 years and who had confirmed ovulation, patent fallopian tubes, and motile sperm. Most participants in the study had primary infertility. The three randomized groups included 193 women in the expectant management group, 194 women who received 50 mg clomiphene on days 2–6 of a cycle, and 193 women who underwent unstimulated IUI over a period of 6 months. Patients in the treatment arms received up to six cycles of treatment.

Median female age, median body mass index, duration of infertility, and percentage with primary infertility were all similar among the different groups. No significant difference in sperm concentration or sperm motility was seen among the groups.

Based on available follow-up data at 16 months, the rate of live births was similar in the three groups. Thirty-three (17%) of the women in the expectant management group, 26 (14%) in the clomiphene group, and 43 (23%) in the IUI group achieved a live birth. Although significantly more women achieved a live birth in the IUI group, compared with the clomiphene group, neither active treatment was superior when compared with expectant management.

Dr. Bhattacharya said that providers tend to ignore the chance of a spontaneous pregnancy occurring in a general population of couples seeking infertility treatment. “This study highlights the potential for spontaneous pregnancy,” he said.

Some women probably do benefit from in vitro fertilization (IVF). “[For] those who have tried for a reasonable time and in whom age is an issue, we should think about IVF sooner,” he said.

NEW ORLEANS — Women in their 30s with unexplained infertility do not achieve higher live birth rates when treated with unstimulated intrauterine insemination or clomiphene, compared with expectant management, according to results of a study presented at the annual meeting of the American Society for Reproductive Medicine.

The findings suggest that in some groups of women with unexplained infertility, the option of no treatment may be as effective as treatment with clomiphene or unstimulated intrauterine insemination (IUI) in achieving a live birth, said Professor Siladitya Bhattacharya of the University of Aberdeen (Scotland) on behalf of the Scottish Unexplained Infertility Trial Collaborative Group.

“This really is the largest trial on the subject so far,” Dr. Bhattacharya said in an interview. The result “does not surprise me at all, because the effectiveness of some treatments is based on tradition rather than empirical evidence,” he added.

The study evaluated couples at five centers in Scotland who had experienced infertility for at least 2 years and who had confirmed ovulation, patent fallopian tubes, and motile sperm. Most participants in the study had primary infertility. The three randomized groups included 193 women in the expectant management group, 194 women who received 50 mg clomiphene on days 2–6 of a cycle, and 193 women who underwent unstimulated IUI over a period of 6 months. Patients in the treatment arms received up to six cycles of treatment.

Median female age, median body mass index, duration of infertility, and percentage with primary infertility were all similar among the different groups. No significant difference in sperm concentration or sperm motility was seen among the groups.

Based on available follow-up data at 16 months, the rate of live births was similar in the three groups. Thirty-three (17%) of the women in the expectant management group, 26 (14%) in the clomiphene group, and 43 (23%) in the IUI group achieved a live birth. Although significantly more women achieved a live birth in the IUI group, compared with the clomiphene group, neither active treatment was superior when compared with expectant management.

Dr. Bhattacharya said that providers tend to ignore the chance of a spontaneous pregnancy occurring in a general population of couples seeking infertility treatment. “This study highlights the potential for spontaneous pregnancy,” he said.

Some women probably do benefit from in vitro fertilization (IVF). “[For] those who have tried for a reasonable time and in whom age is an issue, we should think about IVF sooner,” he said.

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 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 steps in the last 2 years to try to improve 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 physicians can quickly see key information needed for 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.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson of 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 mainly 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 firms 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. 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.”

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs. 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. Such a change would force drug companies to spend more time on innovative drugs and less time developing “me too” products, she said.

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. “There's a balancing act there,” he said.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

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 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 steps in the last 2 years to try to improve 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 physicians can quickly see key information needed for 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.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson of 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 mainly 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 firms 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. 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.”

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs. 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. Such a change would force drug companies to spend more time on innovative drugs and less time developing “me too” products, she said.

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. “There's a balancing act there,” he said.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

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 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 steps in the last 2 years to try to improve 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 physicians can quickly see key information needed for 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.

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.

“The best way to improve drug safety is by improving the science of drug development,” Dr. Galson said.

But the FDA also should improve its postmarketing surveillance, said panelist Dr. John D. Abramson of 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 mainly 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 firms 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. 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.”

She cited Vioxx as an example of a drug that should never have been approved because it had only marginal benefits over existing drugs. 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. Such a change would force drug companies to spend more time on innovative drugs and less time developing “me too” products, she said.

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. “There's a balancing act there,” he said.

Members of Congress also will have a chance to weigh in on FDA reform when the Prescription Drug User Fee Act (PDUFA) comes up for reauthorization in 2007. The PDUFA law, originally passed by Congress in 1992, set up a system in which the pharmaceutical industry pays user fees to the FDA in exchange for the agency's agreeing to meet certain deadlines in the review of drug applications.

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7 to 17.5 years after an initial ultrasound and given a follow-up ultrasound by the same ultrasonographer.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, according to study presenter Meagan K. Murphy, a Harvard University medical student.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology. The researchers concluded that the development of PCOS is uncommon in women with PCOM and regular cycles.

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7 to 17.5 years after an initial ultrasound and given a follow-up ultrasound by the same ultrasonographer.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, according to study presenter Meagan K. Murphy, a Harvard University medical student.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology. The researchers concluded that the development of PCOS is uncommon in women with PCOM and regular cycles.

BOSTON — Women diagnosed with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for developing polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7 to 17.5 years after an initial ultrasound and given a follow-up ultrasound by the same ultrasonographer.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, according to study presenter Meagan K. Murphy, a Harvard University medical student.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology. The researchers concluded that the development of PCOS is uncommon in women with PCOM and regular cycles.

RENO, NEV. — Infants—especially breast-fed infants—at an increased risk for type 1 diabetes aren't getting the recommended levels of vitamin D in their diets, despite efforts to publicize the relationship between type 1 diabetes and insufficient vitamin D, according to a poster presented at the annual meeting of the American College of Nutrition.

Given the reported association between low intake of vitamin D and higher risk for type 1 diabetes, researchers with the Environmental Determinants of Diabetes in the Young (TEDDY) study decided to assess the vitamin D intake of children aged 3–12 months who possess a genetic predisposition to the autoimmunity associated with type 1 diabetes. The dietary intake of the infants was compared with recommendations for vitamin D intake from the American Academy of Pediatrics (AAP).

The researchers analyzed vitamin D intake for 342 infants from the TEDDY centers in Colorado, Georgia, and Florida. Fewer than half of the children in the study (49%) met AAP guidelines for vitamin D intake at 3 months, and 56% met guidelines at 6 months. But compliance with the AAP recommendations increased over time. By 9 months of age, the percentage of infants meeting AAP recommendations for vitamin D intake increased to 73% and continued to rise to 79% by 12 months.

The current AAP recommendation calls for infants to receive 200 IU of vitamin D daily within the first 2 months of life. Infants and children who consume at least 500 mL per day of vitamin D-fortified formula or milk should meet the recommended intake, but vitamin D supplementation is necessary in breast-fed infants, according to the AAP (Pediatrics 2003;111:908–10).

The TEDDY researchers found that infants with very low intakes of vitamin D were predominantly breast fed. Many infants who were primarily formula-fed had vitamin D intakes that were twofold higher than the AAP recommendations. And some formula-fed infants with very large energy intakes were receiving three- to fourfold more than the AAP's recommended daily intake of vitamin D, the researchers wrote.

These preliminary results are based on dietary intake data collected between September 2004 and July 2006. The researchers collected 24-hour diet recall and 3-day food diaries from the primary caretakers. The data collection is ongoing.

The study is funded by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Juvenile Diabetes Research Foundation.

RENO, NEV. — Infants—especially breast-fed infants—at an increased risk for type 1 diabetes aren't getting the recommended levels of vitamin D in their diets, despite efforts to publicize the relationship between type 1 diabetes and insufficient vitamin D, according to a poster presented at the annual meeting of the American College of Nutrition.

Given the reported association between low intake of vitamin D and higher risk for type 1 diabetes, researchers with the Environmental Determinants of Diabetes in the Young (TEDDY) study decided to assess the vitamin D intake of children aged 3–12 months who possess a genetic predisposition to the autoimmunity associated with type 1 diabetes. The dietary intake of the infants was compared with recommendations for vitamin D intake from the American Academy of Pediatrics (AAP).

The researchers analyzed vitamin D intake for 342 infants from the TEDDY centers in Colorado, Georgia, and Florida. Fewer than half of the children in the study (49%) met AAP guidelines for vitamin D intake at 3 months, and 56% met guidelines at 6 months. But compliance with the AAP recommendations increased over time. By 9 months of age, the percentage of infants meeting AAP recommendations for vitamin D intake increased to 73% and continued to rise to 79% by 12 months.

The current AAP recommendation calls for infants to receive 200 IU of vitamin D daily within the first 2 months of life. Infants and children who consume at least 500 mL per day of vitamin D-fortified formula or milk should meet the recommended intake, but vitamin D supplementation is necessary in breast-fed infants, according to the AAP (Pediatrics 2003;111:908–10).

The TEDDY researchers found that infants with very low intakes of vitamin D were predominantly breast fed. Many infants who were primarily formula-fed had vitamin D intakes that were twofold higher than the AAP recommendations. And some formula-fed infants with very large energy intakes were receiving three- to fourfold more than the AAP's recommended daily intake of vitamin D, the researchers wrote.

These preliminary results are based on dietary intake data collected between September 2004 and July 2006. The researchers collected 24-hour diet recall and 3-day food diaries from the primary caretakers. The data collection is ongoing.

The study is funded by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Juvenile Diabetes Research Foundation.

RENO, NEV. — Infants—especially breast-fed infants—at an increased risk for type 1 diabetes aren't getting the recommended levels of vitamin D in their diets, despite efforts to publicize the relationship between type 1 diabetes and insufficient vitamin D, according to a poster presented at the annual meeting of the American College of Nutrition.

Given the reported association between low intake of vitamin D and higher risk for type 1 diabetes, researchers with the Environmental Determinants of Diabetes in the Young (TEDDY) study decided to assess the vitamin D intake of children aged 3–12 months who possess a genetic predisposition to the autoimmunity associated with type 1 diabetes. The dietary intake of the infants was compared with recommendations for vitamin D intake from the American Academy of Pediatrics (AAP).

The researchers analyzed vitamin D intake for 342 infants from the TEDDY centers in Colorado, Georgia, and Florida. Fewer than half of the children in the study (49%) met AAP guidelines for vitamin D intake at 3 months, and 56% met guidelines at 6 months. But compliance with the AAP recommendations increased over time. By 9 months of age, the percentage of infants meeting AAP recommendations for vitamin D intake increased to 73% and continued to rise to 79% by 12 months.

The current AAP recommendation calls for infants to receive 200 IU of vitamin D daily within the first 2 months of life. Infants and children who consume at least 500 mL per day of vitamin D-fortified formula or milk should meet the recommended intake, but vitamin D supplementation is necessary in breast-fed infants, according to the AAP (Pediatrics 2003;111:908–10).

The TEDDY researchers found that infants with very low intakes of vitamin D were predominantly breast fed. Many infants who were primarily formula-fed had vitamin D intakes that were twofold higher than the AAP recommendations. And some formula-fed infants with very large energy intakes were receiving three- to fourfold more than the AAP's recommended daily intake of vitamin D, the researchers wrote.

These preliminary results are based on dietary intake data collected between September 2004 and July 2006. The researchers collected 24-hour diet recall and 3-day food diaries from the primary caretakers. The data collection is ongoing.

The study is funded by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Juvenile Diabetes Research Foundation.

Some Abortion Materials Misleading

Some state-mandated abortion-specific informed consent materials include inaccurate or biased information, according to an analysis by the Guttmacher Institute. The researchers analyzed written materials from 22 states and found that while most of the materials were consistent with scientific findings, some content related to breast cancer, psychological impact, and fetal pain was wrong or misleading. For example, five of the six states that have developed written materials that relate to abortion and breast cancer have falsely asserted a possible link; only one state reported that abortion does not increase the risk of developing breast cancer as determined by the National Cancer Institute in 2003. “Rather than creating new barriers for women seeking an abortion, policy makers should instead focus on helping women avoid unintended pregnancies in the first place,” Guttmacher Institute president Sharon L. Camp said in a statement.

$9 BPublic Price Tag for Teen Births

The public cost of births to teenage mothers was more than $9 billion in 2004, according to an estimate of costs to federal, state, and local governments for all births to women aged 19 years and younger prepared by the National Campaign to Prevent Teen Pregnancy. The estimate includes increases in public sector health care costs for the baby, increased child welfare payments and other public assistance, increased costs to state prisons for the children of teen mothers, and lost revenue because of lower taxes paid by parents and the children over their adult lifetimes.

Insurer Faces $144 M in Damages

The insurer Amerigroup Illinois, along with its parent company Amerigroup Corporation, could face $144 million in damages because of charges that the company discriminated against pregnant women and others with chronic illnesses in its enrollment policies. The former head of government relations for Amerigroup Illinois filed the lawsuit alleging that from 2000 to 2004, Amerigroup avoided enrolling pregnant women and others with chronic health conditions in a Medicaid managed care plan in Illinois but continued to accept state and federal health funds for the program. A federal jury found Amerigroup Illinois and Amerigroup Corporation liable for $48 million in damages. That amount will be tripled—to $144 million—under the federal False Claims Act and the Illinois Whistleblower Reward and Protection Act. Amerigroup chairman and CEO Jeffrey L. McWaters said in a statement that the company “vigorously” disagrees with the verdict and will appeal the decision.

WIC Canned-Tuna Rule Challenged

Environmental advocates are urging the U.S. Department of Agriculture to stop providing canned tuna as part of the food package of the Women, Infants, and Children program. GotMercury.org, a project of the Turtle Island Restoration Network, wrote a letter to USDA urging officials there to stop offering canned tuna to breast-feeding women because of the risks of exposure to mercury through tuna consumption. Although USDA's proposed rule eliminates canned albacore (marketed as solid or “white”) tuna from the WIC food basket because albacore generally has higher levels of mercury, it retains other (chunk or “light”) canned tuna. GotMercury.org opposes this because there are no federal standards defining what can be sold as light tuna. Instead, the group wants to see alternative fish products with lower mercury content offered as part of the WIC food packages, including canned wild salmon, mackerel, anchovies, or sardines. “No one needs pollution on their plate when there are healthier alternatives,” Eli Saddler, a public health analyst for GotMercury.org said in a statement. The Environmental Protection Agency and the Food and Drug Administration currently advise that pregnant women, nursing mothers, young children, and women who may become pregnant eat up to 12 ounces a week of a variety of fish and shellfish that are lower in mercury. The advisory recommends that women and young children avoid shark, swordfish, king mackerel, and tilefish due to high levels of mercury.

Telehealth Licensure Studied

Officials at the Federation of State Medical Boards (FSMB) are tackling the issue of licensure for physicians engaged in telehealth and those involved in the multistate practice of medicine. FSMB recently received a grant from the federal government to test different ways to reduce licensure barriers and better share information across jurisdictions. “With telehealth playing an increasingly important role in meeting the needs of underserved patient populations, the ability of physicians to be able to quickly obtain licensure in multiple jurisdictions has never been more important,” Dr. James N. Thompson, FSMB president and CEO, said in a statement.

Some Abortion Materials Misleading

Some state-mandated abortion-specific informed consent materials include inaccurate or biased information, according to an analysis by the Guttmacher Institute. The researchers analyzed written materials from 22 states and found that while most of the materials were consistent with scientific findings, some content related to breast cancer, psychological impact, and fetal pain was wrong or misleading. For example, five of the six states that have developed written materials that relate to abortion and breast cancer have falsely asserted a possible link; only one state reported that abortion does not increase the risk of developing breast cancer as determined by the National Cancer Institute in 2003. “Rather than creating new barriers for women seeking an abortion, policy makers should instead focus on helping women avoid unintended pregnancies in the first place,” Guttmacher Institute president Sharon L. Camp said in a statement.

$9 BPublic Price Tag for Teen Births

The public cost of births to teenage mothers was more than $9 billion in 2004, according to an estimate of costs to federal, state, and local governments for all births to women aged 19 years and younger prepared by the National Campaign to Prevent Teen Pregnancy. The estimate includes increases in public sector health care costs for the baby, increased child welfare payments and other public assistance, increased costs to state prisons for the children of teen mothers, and lost revenue because of lower taxes paid by parents and the children over their adult lifetimes.

Insurer Faces $144 M in Damages

The insurer Amerigroup Illinois, along with its parent company Amerigroup Corporation, could face $144 million in damages because of charges that the company discriminated against pregnant women and others with chronic illnesses in its enrollment policies. The former head of government relations for Amerigroup Illinois filed the lawsuit alleging that from 2000 to 2004, Amerigroup avoided enrolling pregnant women and others with chronic health conditions in a Medicaid managed care plan in Illinois but continued to accept state and federal health funds for the program. A federal jury found Amerigroup Illinois and Amerigroup Corporation liable for $48 million in damages. That amount will be tripled—to $144 million—under the federal False Claims Act and the Illinois Whistleblower Reward and Protection Act. Amerigroup chairman and CEO Jeffrey L. McWaters said in a statement that the company “vigorously” disagrees with the verdict and will appeal the decision.

WIC Canned-Tuna Rule Challenged

Environmental advocates are urging the U.S. Department of Agriculture to stop providing canned tuna as part of the food package of the Women, Infants, and Children program. GotMercury.org, a project of the Turtle Island Restoration Network, wrote a letter to USDA urging officials there to stop offering canned tuna to breast-feeding women because of the risks of exposure to mercury through tuna consumption. Although USDA's proposed rule eliminates canned albacore (marketed as solid or “white”) tuna from the WIC food basket because albacore generally has higher levels of mercury, it retains other (chunk or “light”) canned tuna. GotMercury.org opposes this because there are no federal standards defining what can be sold as light tuna. Instead, the group wants to see alternative fish products with lower mercury content offered as part of the WIC food packages, including canned wild salmon, mackerel, anchovies, or sardines. “No one needs pollution on their plate when there are healthier alternatives,” Eli Saddler, a public health analyst for GotMercury.org said in a statement. The Environmental Protection Agency and the Food and Drug Administration currently advise that pregnant women, nursing mothers, young children, and women who may become pregnant eat up to 12 ounces a week of a variety of fish and shellfish that are lower in mercury. The advisory recommends that women and young children avoid shark, swordfish, king mackerel, and tilefish due to high levels of mercury.

Telehealth Licensure Studied

Officials at the Federation of State Medical Boards (FSMB) are tackling the issue of licensure for physicians engaged in telehealth and those involved in the multistate practice of medicine. FSMB recently received a grant from the federal government to test different ways to reduce licensure barriers and better share information across jurisdictions. “With telehealth playing an increasingly important role in meeting the needs of underserved patient populations, the ability of physicians to be able to quickly obtain licensure in multiple jurisdictions has never been more important,” Dr. James N. Thompson, FSMB president and CEO, said in a statement.

Some Abortion Materials Misleading

Some state-mandated abortion-specific informed consent materials include inaccurate or biased information, according to an analysis by the Guttmacher Institute. The researchers analyzed written materials from 22 states and found that while most of the materials were consistent with scientific findings, some content related to breast cancer, psychological impact, and fetal pain was wrong or misleading. For example, five of the six states that have developed written materials that relate to abortion and breast cancer have falsely asserted a possible link; only one state reported that abortion does not increase the risk of developing breast cancer as determined by the National Cancer Institute in 2003. “Rather than creating new barriers for women seeking an abortion, policy makers should instead focus on helping women avoid unintended pregnancies in the first place,” Guttmacher Institute president Sharon L. Camp said in a statement.

$9 BPublic Price Tag for Teen Births

The public cost of births to teenage mothers was more than $9 billion in 2004, according to an estimate of costs to federal, state, and local governments for all births to women aged 19 years and younger prepared by the National Campaign to Prevent Teen Pregnancy. The estimate includes increases in public sector health care costs for the baby, increased child welfare payments and other public assistance, increased costs to state prisons for the children of teen mothers, and lost revenue because of lower taxes paid by parents and the children over their adult lifetimes.

Insurer Faces $144 M in Damages

The insurer Amerigroup Illinois, along with its parent company Amerigroup Corporation, could face $144 million in damages because of charges that the company discriminated against pregnant women and others with chronic illnesses in its enrollment policies. The former head of government relations for Amerigroup Illinois filed the lawsuit alleging that from 2000 to 2004, Amerigroup avoided enrolling pregnant women and others with chronic health conditions in a Medicaid managed care plan in Illinois but continued to accept state and federal health funds for the program. A federal jury found Amerigroup Illinois and Amerigroup Corporation liable for $48 million in damages. That amount will be tripled—to $144 million—under the federal False Claims Act and the Illinois Whistleblower Reward and Protection Act. Amerigroup chairman and CEO Jeffrey L. McWaters said in a statement that the company “vigorously” disagrees with the verdict and will appeal the decision.

WIC Canned-Tuna Rule Challenged

Environmental advocates are urging the U.S. Department of Agriculture to stop providing canned tuna as part of the food package of the Women, Infants, and Children program. GotMercury.org, a project of the Turtle Island Restoration Network, wrote a letter to USDA urging officials there to stop offering canned tuna to breast-feeding women because of the risks of exposure to mercury through tuna consumption. Although USDA's proposed rule eliminates canned albacore (marketed as solid or “white”) tuna from the WIC food basket because albacore generally has higher levels of mercury, it retains other (chunk or “light”) canned tuna. GotMercury.org opposes this because there are no federal standards defining what can be sold as light tuna. Instead, the group wants to see alternative fish products with lower mercury content offered as part of the WIC food packages, including canned wild salmon, mackerel, anchovies, or sardines. “No one needs pollution on their plate when there are healthier alternatives,” Eli Saddler, a public health analyst for GotMercury.org said in a statement. The Environmental Protection Agency and the Food and Drug Administration currently advise that pregnant women, nursing mothers, young children, and women who may become pregnant eat up to 12 ounces a week of a variety of fish and shellfish that are lower in mercury. The advisory recommends that women and young children avoid shark, swordfish, king mackerel, and tilefish due to high levels of mercury.

Telehealth Licensure Studied

Officials at the Federation of State Medical Boards (FSMB) are tackling the issue of licensure for physicians engaged in telehealth and those involved in the multistate practice of medicine. FSMB recently received a grant from the federal government to test different ways to reduce licensure barriers and better share information across jurisdictions. “With telehealth playing an increasingly important role in meeting the needs of underserved patient populations, the ability of physicians to be able to quickly obtain licensure in multiple jurisdictions has never been more important,” Dr. James N. Thompson, FSMB president and CEO, said in a statement.

BOSTON — Voters in several states made their voices heard last month on public health issues ranging from smoking bans to restrictions on abortion to the minimum wage.

Public health experts offered their views on the ballot initiatives at the annual meeting of the American Public Health Association (APHA). The following is a sample of the some of the issues that appeared on the ballot on Nov. 7:

Reproductive Health

Voters in three states defeated restrictions on abortion last month, including the far-reaching ban that was passed by the South Dakota legislature earlier this year.

The controversial South Dakota law would have outlawed abortion in all cases except to save the life of the mother. The law did not include exceptions in cases where the abortion is necessary to preserve the woman's health or in cases of rape or incest. After the law was signed by the governor earlier this year, opponents began a petition to force the issue onto the November ballot. If voters had approved the ballot measure, the issue would ultimately have been decided in the courts, resulting in a direct challenge to Roe v. Wade. With the legislation defeated by the voters, current South Dakota law allows a woman to obtain an abortion during the first 24 weeks of pregnancy. After that time, abortions can be performed only to preserve the life or health of the woman.

In Oregon and California, voters rejected measures that would have required physicians to notify a minor's parents before performing an abortion. California's proposition 85 would have amended the state's constitution to prohibit physicians from performing an abortion on an unemancipated minor until 48 hours after notifying a parent or legal guardian. This is not the first time that California voters have dealt with this issue. Last year they defeated the same measure in a special election.

Oregon's measure 43 would have required a physician to provide written notice to a parent of an unemancipated minor age 15 and older at least 48 hours before providing the abortion. Under current law, parental consent for an abortion is required for minors younger than 15.

Lois Uttley, director of the MergerWatch Project, a group that advocates for greater access to reproductive health services, told this news organization that in an ideal world, girls would seek parental advice, but mandating parental involvement can lead to abuse. Instead, age-appropriate sex education, which includes both abstinence education and birth control, are more appropriate answers, said Ms. Uttley, who is the chair of the APHA Action Board. “Good family communication unfortunately cannot be imposed by the government,” she said.

Smoking Restrictions

Results were mixed on public health initiatives related to tobacco. Voters in Arizona, Nevada, and Ohio passed statewide smoking restrictions. But voters were split in their support for raising taxes on cigarettes and other tobacco products, with Arizona and South Dakota approving tax increases while California and Missouri rejected them.

“I think the United States has made great progress,” said Frances Stillman, codirector of the Institute for Global Tobacco Control at Johns Hopkins University in Baltimore.

Social norms around smoking are starting to change but that progress could be in jeopardy due to a lack of public funding in the states, said Ms. Stillman, immediate past chair of the APHA section on alcohol, tobacco, and other drugs.

Despite the number of states moving toward smoking bans, Ms. Stillman does not foresee a federal ban on smoking anytime soon. And local action benefits antismoking advocates, she said, because it's harder for the tobacco industry to fight these efforts around the country. “They can't be everywhere at once,” she said.

If there is a single effort at the federal level it should be for the Food and Drug Administration to regulate tobacco, said Dr. Georges Benjamin, executive director of the APHA.

In Arizona, voters passed Proposition 201, the Smoke-Free Arizona Act, which prohibits smoking in all public places and places of employment except retail tobacco stores, veterans' and fraternal clubs, certain designated hotel rooms, and outdoor patios. The proposition also imposes an increase on cigarette taxes.

Arizona voters also passed an initiative to establish an early childhood development and health fund that would be supported in part by revenues from the increase in the state tax on tobacco products. The voters also rejected a ballot initiative that prohibited smoking in many public places but would have exempted bars and parts of restaurants that have a separate ventilation system.

Nevada voters passed a ballot question to ban smoking in a number of indoor areas including child care facilities, government buildings, public places, all bars with a food-handling license, and all indoor restaurants. Exceptions include stand-alone bars, casinos, strip clubs or brothels, and retail tobacco stores. This initiative allows cities and towns to adopt stricter laws.

Voters in Nevada rejected a similar-sounding initiative that would have prevented local counties and towns from passing stricter regulations related to smoking.

Ohio voters took similar action on two of their ballot questions. They passed a proposal to prohibit smoking in a number of public places and rejected a proposal that would have called for similar prohibitions on smoking but would have stricken from the books any stricter local laws on smoking.

Voters in Florida passed a constitutional amendment to use tobacco settlement money to fund a statewide tobacco education and prevention program. Voters in South Dakota passed a measure to increase taxes on cigarettes and dedicate a portion of those funds to tobacco-prevention programs. In California and Missouri. initiatives that would have increased taxes on cigarettes failed.

Minimum Wage

Minimum wage hikes passed in all six states where they were proposed, raising the minimum wage as high as $6.85 per hour in Ohio and Colorado.

The federal minimum wage is set at $5.15 per hour but about half the states have higher minimum wage laws. Washington state has the highest minimum wage among the states at $7.63 per hour, according to the National Conference of State Legislatures.

Voters raised the minimum wage to $6.50 in Missouri, $6.15 in Montana, $6.75 in Arizona, $6.85 in Ohio, and $6.85 in Colorado. In Nevada, voters approved a dual minimum wage scale:$5.15 if an employer provides health insurance, $6.15 without the health insurance benefit.

BOSTON — Voters in several states made their voices heard last month on public health issues ranging from smoking bans to restrictions on abortion to the minimum wage.

Public health experts offered their views on the ballot initiatives at the annual meeting of the American Public Health Association (APHA). The following is a sample of the some of the issues that appeared on the ballot on Nov. 7:

Reproductive Health

Voters in three states defeated restrictions on abortion last month, including the far-reaching ban that was passed by the South Dakota legislature earlier this year.

The controversial South Dakota law would have outlawed abortion in all cases except to save the life of the mother. The law did not include exceptions in cases where the abortion is necessary to preserve the woman's health or in cases of rape or incest. After the law was signed by the governor earlier this year, opponents began a petition to force the issue onto the November ballot. If voters had approved the ballot measure, the issue would ultimately have been decided in the courts, resulting in a direct challenge to Roe v. Wade. With the legislation defeated by the voters, current South Dakota law allows a woman to obtain an abortion during the first 24 weeks of pregnancy. After that time, abortions can be performed only to preserve the life or health of the woman.

In Oregon and California, voters rejected measures that would have required physicians to notify a minor's parents before performing an abortion. California's proposition 85 would have amended the state's constitution to prohibit physicians from performing an abortion on an unemancipated minor until 48 hours after notifying a parent or legal guardian. This is not the first time that California voters have dealt with this issue. Last year they defeated the same measure in a special election.

Oregon's measure 43 would have required a physician to provide written notice to a parent of an unemancipated minor age 15 and older at least 48 hours before providing the abortion. Under current law, parental consent for an abortion is required for minors younger than 15.

Lois Uttley, director of the MergerWatch Project, a group that advocates for greater access to reproductive health services, told this news organization that in an ideal world, girls would seek parental advice, but mandating parental involvement can lead to abuse. Instead, age-appropriate sex education, which includes both abstinence education and birth control, are more appropriate answers, said Ms. Uttley, who is the chair of the APHA Action Board. “Good family communication unfortunately cannot be imposed by the government,” she said.

Smoking Restrictions

Results were mixed on public health initiatives related to tobacco. Voters in Arizona, Nevada, and Ohio passed statewide smoking restrictions. But voters were split in their support for raising taxes on cigarettes and other tobacco products, with Arizona and South Dakota approving tax increases while California and Missouri rejected them.

“I think the United States has made great progress,” said Frances Stillman, codirector of the Institute for Global Tobacco Control at Johns Hopkins University in Baltimore.

Social norms around smoking are starting to change but that progress could be in jeopardy due to a lack of public funding in the states, said Ms. Stillman, immediate past chair of the APHA section on alcohol, tobacco, and other drugs.

Despite the number of states moving toward smoking bans, Ms. Stillman does not foresee a federal ban on smoking anytime soon. And local action benefits antismoking advocates, she said, because it's harder for the tobacco industry to fight these efforts around the country. “They can't be everywhere at once,” she said.

If there is a single effort at the federal level it should be for the Food and Drug Administration to regulate tobacco, said Dr. Georges Benjamin, executive director of the APHA.

In Arizona, voters passed Proposition 201, the Smoke-Free Arizona Act, which prohibits smoking in all public places and places of employment except retail tobacco stores, veterans' and fraternal clubs, certain designated hotel rooms, and outdoor patios. The proposition also imposes an increase on cigarette taxes.

Arizona voters also passed an initiative to establish an early childhood development and health fund that would be supported in part by revenues from the increase in the state tax on tobacco products. The voters also rejected a ballot initiative that prohibited smoking in many public places but would have exempted bars and parts of restaurants that have a separate ventilation system.

Nevada voters passed a ballot question to ban smoking in a number of indoor areas including child care facilities, government buildings, public places, all bars with a food-handling license, and all indoor restaurants. Exceptions include stand-alone bars, casinos, strip clubs or brothels, and retail tobacco stores. This initiative allows cities and towns to adopt stricter laws.

Voters in Nevada rejected a similar-sounding initiative that would have prevented local counties and towns from passing stricter regulations related to smoking.

Ohio voters took similar action on two of their ballot questions. They passed a proposal to prohibit smoking in a number of public places and rejected a proposal that would have called for similar prohibitions on smoking but would have stricken from the books any stricter local laws on smoking.

Voters in Florida passed a constitutional amendment to use tobacco settlement money to fund a statewide tobacco education and prevention program. Voters in South Dakota passed a measure to increase taxes on cigarettes and dedicate a portion of those funds to tobacco-prevention programs. In California and Missouri. initiatives that would have increased taxes on cigarettes failed.

Minimum Wage

Minimum wage hikes passed in all six states where they were proposed, raising the minimum wage as high as $6.85 per hour in Ohio and Colorado.

The federal minimum wage is set at $5.15 per hour but about half the states have higher minimum wage laws. Washington state has the highest minimum wage among the states at $7.63 per hour, according to the National Conference of State Legislatures.

Voters raised the minimum wage to $6.50 in Missouri, $6.15 in Montana, $6.75 in Arizona, $6.85 in Ohio, and $6.85 in Colorado. In Nevada, voters approved a dual minimum wage scale:$5.15 if an employer provides health insurance, $6.15 without the health insurance benefit.

BOSTON — Voters in several states made their voices heard last month on public health issues ranging from smoking bans to restrictions on abortion to the minimum wage.

Public health experts offered their views on the ballot initiatives at the annual meeting of the American Public Health Association (APHA). The following is a sample of the some of the issues that appeared on the ballot on Nov. 7:

Reproductive Health

Voters in three states defeated restrictions on abortion last month, including the far-reaching ban that was passed by the South Dakota legislature earlier this year.

The controversial South Dakota law would have outlawed abortion in all cases except to save the life of the mother. The law did not include exceptions in cases where the abortion is necessary to preserve the woman's health or in cases of rape or incest. After the law was signed by the governor earlier this year, opponents began a petition to force the issue onto the November ballot. If voters had approved the ballot measure, the issue would ultimately have been decided in the courts, resulting in a direct challenge to Roe v. Wade. With the legislation defeated by the voters, current South Dakota law allows a woman to obtain an abortion during the first 24 weeks of pregnancy. After that time, abortions can be performed only to preserve the life or health of the woman.

In Oregon and California, voters rejected measures that would have required physicians to notify a minor's parents before performing an abortion. California's proposition 85 would have amended the state's constitution to prohibit physicians from performing an abortion on an unemancipated minor until 48 hours after notifying a parent or legal guardian. This is not the first time that California voters have dealt with this issue. Last year they defeated the same measure in a special election.

Oregon's measure 43 would have required a physician to provide written notice to a parent of an unemancipated minor age 15 and older at least 48 hours before providing the abortion. Under current law, parental consent for an abortion is required for minors younger than 15.

Lois Uttley, director of the MergerWatch Project, a group that advocates for greater access to reproductive health services, told this news organization that in an ideal world, girls would seek parental advice, but mandating parental involvement can lead to abuse. Instead, age-appropriate sex education, which includes both abstinence education and birth control, are more appropriate answers, said Ms. Uttley, who is the chair of the APHA Action Board. “Good family communication unfortunately cannot be imposed by the government,” she said.

Smoking Restrictions

Results were mixed on public health initiatives related to tobacco. Voters in Arizona, Nevada, and Ohio passed statewide smoking restrictions. But voters were split in their support for raising taxes on cigarettes and other tobacco products, with Arizona and South Dakota approving tax increases while California and Missouri rejected them.

“I think the United States has made great progress,” said Frances Stillman, codirector of the Institute for Global Tobacco Control at Johns Hopkins University in Baltimore.

Social norms around smoking are starting to change but that progress could be in jeopardy due to a lack of public funding in the states, said Ms. Stillman, immediate past chair of the APHA section on alcohol, tobacco, and other drugs.

Despite the number of states moving toward smoking bans, Ms. Stillman does not foresee a federal ban on smoking anytime soon. And local action benefits antismoking advocates, she said, because it's harder for the tobacco industry to fight these efforts around the country. “They can't be everywhere at once,” she said.

If there is a single effort at the federal level it should be for the Food and Drug Administration to regulate tobacco, said Dr. Georges Benjamin, executive director of the APHA.

In Arizona, voters passed Proposition 201, the Smoke-Free Arizona Act, which prohibits smoking in all public places and places of employment except retail tobacco stores, veterans' and fraternal clubs, certain designated hotel rooms, and outdoor patios. The proposition also imposes an increase on cigarette taxes.

Arizona voters also passed an initiative to establish an early childhood development and health fund that would be supported in part by revenues from the increase in the state tax on tobacco products. The voters also rejected a ballot initiative that prohibited smoking in many public places but would have exempted bars and parts of restaurants that have a separate ventilation system.

Nevada voters passed a ballot question to ban smoking in a number of indoor areas including child care facilities, government buildings, public places, all bars with a food-handling license, and all indoor restaurants. Exceptions include stand-alone bars, casinos, strip clubs or brothels, and retail tobacco stores. This initiative allows cities and towns to adopt stricter laws.

Voters in Nevada rejected a similar-sounding initiative that would have prevented local counties and towns from passing stricter regulations related to smoking.

Ohio voters took similar action on two of their ballot questions. They passed a proposal to prohibit smoking in a number of public places and rejected a proposal that would have called for similar prohibitions on smoking but would have stricken from the books any stricter local laws on smoking.

Voters in Florida passed a constitutional amendment to use tobacco settlement money to fund a statewide tobacco education and prevention program. Voters in South Dakota passed a measure to increase taxes on cigarettes and dedicate a portion of those funds to tobacco-prevention programs. In California and Missouri. initiatives that would have increased taxes on cigarettes failed.

Minimum Wage

Minimum wage hikes passed in all six states where they were proposed, raising the minimum wage as high as $6.85 per hour in Ohio and Colorado.

The federal minimum wage is set at $5.15 per hour but about half the states have higher minimum wage laws. Washington state has the highest minimum wage among the states at $7.63 per hour, according to the National Conference of State Legislatures.

Voters raised the minimum wage to $6.50 in Missouri, $6.15 in Montana, $6.75 in Arizona, $6.85 in Ohio, and $6.85 in Colorado. In Nevada, voters approved a dual minimum wage scale:$5.15 if an employer provides health insurance, $6.15 without the health insurance benefit.

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach finally was confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

Researcher Pleads Guilty

A senior Alzheimer's disease researcher at the National Institutes of Health pleaded guilty this month to violating federal conflict of interest regulations. Dr. Pearson “Trey” Sunderland III, who served as chief of the geriatric psychiatry branch at the National Institute of Mental Health from 1997 to 2004, admitted to accepting approximately $300,000 in consulting fees and travel expenses from Pfizer Inc. without disclosure to and approval from NIH officials. In a federal “criminal information” filing made in December by the U.S. Attorney for the District of Maryland, Dr. Sunderland is alleged to have agreed to work as a consultant to Pfizer on two research projects that he was already involved with in his official capacity at NIH. Under an agreement with prosecuters, Dr. Sunderland faces 2 years of probation provided he forfeits the income and expenses from Pfizer, performs 400 hours of community service, and pays a yet-to-be determined fine. At press time, the NIH had no comment on the case. In a statement, Pfizer officials said the company's actions complied with applicable laws and ethical standards.

Coverage for Intracranial Stenting

Officials at the CMS announced plans to cover intracranial percutaneous transluminal angioplasty (PTA) and stenting for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease. But Medicare coverage will include only PTA and stenting that is done under the auspices of a Category B Investigational Device Exemption clinical trial using FDA-approved protocols. Any other use is still uncovered. Prior to the new coverage decision, PTA of the carotid artery was covered by Medicare when it was performed on patients who were at high risk for carotid endarterectomy and who also had symptomatic carotid artery stenosis of 70% or greater, and performed in a Medicare-approved facility with FDA-approved carotid artery stenting systems and embolic protection devices. While the studies reviewed by CMS showed a benefit to the use of PTA and stenting, Medicare officials also noted that there was “insufficient evidence” to conclude that the devices should be used without some type of limitations. CMS is separately evaluating a request to expand coverage for humanitarian use devices such as the Wingspan Stent System, marketed by Boston Scientific Corporation.

Power Mobility Device Coverage

Medicare officials announced that CMS will increase the fees for complex rehabilitation power wheelchairs used by the severely disabled. Fees for standard geriatric mobility power wheelchairs will also increase. The price increases are intended to reflect the greater durability and performance of these chairs, compared with others, according to officials from CMS. The refinements are based on updated and validated information related to manufacturer applications and test results. For more information on the code, see:

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Part D Model Guidelines

The United States Pharmacopeia (USP) has recently released a draft of the third version of the Medicare Part D Model Guidelines, which list therapeutic categories, pharmacologic classes, and key formulary drug types from which drug plans should offer medications. About 80% of Part D drug plans base their formularies on the guidelines. The USP expert panel will submit a finalized version of the guidelines to CMS officials by Feb. 5, 2007. The draft guidelines are available online at

www.usp.org

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach finally was confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

Researcher Pleads Guilty

A senior Alzheimer's disease researcher at the National Institutes of Health pleaded guilty this month to violating federal conflict of interest regulations. Dr. Pearson “Trey” Sunderland III, who served as chief of the geriatric psychiatry branch at the National Institute of Mental Health from 1997 to 2004, admitted to accepting approximately $300,000 in consulting fees and travel expenses from Pfizer Inc. without disclosure to and approval from NIH officials. In a federal “criminal information” filing made in December by the U.S. Attorney for the District of Maryland, Dr. Sunderland is alleged to have agreed to work as a consultant to Pfizer on two research projects that he was already involved with in his official capacity at NIH. Under an agreement with prosecuters, Dr. Sunderland faces 2 years of probation provided he forfeits the income and expenses from Pfizer, performs 400 hours of community service, and pays a yet-to-be determined fine. At press time, the NIH had no comment on the case. In a statement, Pfizer officials said the company's actions complied with applicable laws and ethical standards.

Coverage for Intracranial Stenting

Officials at the CMS announced plans to cover intracranial percutaneous transluminal angioplasty (PTA) and stenting for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease. But Medicare coverage will include only PTA and stenting that is done under the auspices of a Category B Investigational Device Exemption clinical trial using FDA-approved protocols. Any other use is still uncovered. Prior to the new coverage decision, PTA of the carotid artery was covered by Medicare when it was performed on patients who were at high risk for carotid endarterectomy and who also had symptomatic carotid artery stenosis of 70% or greater, and performed in a Medicare-approved facility with FDA-approved carotid artery stenting systems and embolic protection devices. While the studies reviewed by CMS showed a benefit to the use of PTA and stenting, Medicare officials also noted that there was “insufficient evidence” to conclude that the devices should be used without some type of limitations. CMS is separately evaluating a request to expand coverage for humanitarian use devices such as the Wingspan Stent System, marketed by Boston Scientific Corporation.

Power Mobility Device Coverage

Medicare officials announced that CMS will increase the fees for complex rehabilitation power wheelchairs used by the severely disabled. Fees for standard geriatric mobility power wheelchairs will also increase. The price increases are intended to reflect the greater durability and performance of these chairs, compared with others, according to officials from CMS. The refinements are based on updated and validated information related to manufacturer applications and test results. For more information on the code, see:

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Part D Model Guidelines

The United States Pharmacopeia (USP) has recently released a draft of the third version of the Medicare Part D Model Guidelines, which list therapeutic categories, pharmacologic classes, and key formulary drug types from which drug plans should offer medications. About 80% of Part D drug plans base their formularies on the guidelines. The USP expert panel will submit a finalized version of the guidelines to CMS officials by Feb. 5, 2007. The draft guidelines are available online at

www.usp.org

Von Eschenbach Confirmed for FDA

Almost 9 months after he was first nominated to be Food and Drug Administration commissioner, Dr. Andrew von Eschenbach finally was confirmed by the Senate by an 80–11 vote in the wee hours of the 109th Congress. Confirmation came after an 89–6 vote to limit debate on his nomination. The naysayers included Sen. Chuck Grassley (R-Iowa), one of Dr. von Eschenbach's most vocal critics. As chairman of the Finance Committee, he and his staff have been investigating what they call an inappropriate approval of Ketek (telithromycin). Sen. Grassley maintains that Dr. von Eschenbach has stonewalled committee investigators, and in an agitated floor statement during the nomination vote, he accused the nominee of hiding documents and intimidating FDA employees who dissented. Sen. Grassley warned his colleagues that Dr. von Eschenbach was a prime illustration of concerns about the lack of Senate oversight of the Bush administration. “I believe we need to send a message to the executive branch that it's not okay to impede congressional investigations. It's not okay to limit the Senate's access to documents, information, and employees of the executive branch,” the senator said.

Researcher Pleads Guilty

A senior Alzheimer's disease researcher at the National Institutes of Health pleaded guilty this month to violating federal conflict of interest regulations. Dr. Pearson “Trey” Sunderland III, who served as chief of the geriatric psychiatry branch at the National Institute of Mental Health from 1997 to 2004, admitted to accepting approximately $300,000 in consulting fees and travel expenses from Pfizer Inc. without disclosure to and approval from NIH officials. In a federal “criminal information” filing made in December by the U.S. Attorney for the District of Maryland, Dr. Sunderland is alleged to have agreed to work as a consultant to Pfizer on two research projects that he was already involved with in his official capacity at NIH. Under an agreement with prosecuters, Dr. Sunderland faces 2 years of probation provided he forfeits the income and expenses from Pfizer, performs 400 hours of community service, and pays a yet-to-be determined fine. At press time, the NIH had no comment on the case. In a statement, Pfizer officials said the company's actions complied with applicable laws and ethical standards.

Coverage for Intracranial Stenting

Officials at the CMS announced plans to cover intracranial percutaneous transluminal angioplasty (PTA) and stenting for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease. But Medicare coverage will include only PTA and stenting that is done under the auspices of a Category B Investigational Device Exemption clinical trial using FDA-approved protocols. Any other use is still uncovered. Prior to the new coverage decision, PTA of the carotid artery was covered by Medicare when it was performed on patients who were at high risk for carotid endarterectomy and who also had symptomatic carotid artery stenosis of 70% or greater, and performed in a Medicare-approved facility with FDA-approved carotid artery stenting systems and embolic protection devices. While the studies reviewed by CMS showed a benefit to the use of PTA and stenting, Medicare officials also noted that there was “insufficient evidence” to conclude that the devices should be used without some type of limitations. CMS is separately evaluating a request to expand coverage for humanitarian use devices such as the Wingspan Stent System, marketed by Boston Scientific Corporation.

Power Mobility Device Coverage

Medicare officials announced that CMS will increase the fees for complex rehabilitation power wheelchairs used by the severely disabled. Fees for standard geriatric mobility power wheelchairs will also increase. The price increases are intended to reflect the greater durability and performance of these chairs, compared with others, according to officials from CMS. The refinements are based on updated and validated information related to manufacturer applications and test results. For more information on the code, see:

https://www.cms.hhs.gov/DMEPOSFeeSched/01a_Power_Mobility_Devices.asp

Part D Model Guidelines

The United States Pharmacopeia (USP) has recently released a draft of the third version of the Medicare Part D Model Guidelines, which list therapeutic categories, pharmacologic classes, and key formulary drug types from which drug plans should offer medications. About 80% of Part D drug plans base their formularies on the guidelines. The USP expert panel will submit a finalized version of the guidelines to CMS officials by Feb. 5, 2007. The draft guidelines are available online at

www.usp.org

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 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. 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.

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 added.

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.

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 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. 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.

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 added.

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.

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 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. 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.

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 added.

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.