Doug Brunk

Once-monthly treatment with extended-release injectable naltrexone helped patients who were dependent on opioids maintain an opioid-free state after detoxification, results from a placebo-controlled study demonstrated.

After 24 weeks of treatment, patients in the naltrexone treatment group had significant improvements compared with the placebo group in reduced opioid use, craving, and improved treatment retention.

Extended-release injectable naltrexone, marketed by Alkermes Inc. as Vivitrol, is an opioid antagonist administered once monthly by intramuscular injection and is approved in the United States for the treatment of alcohol dependence.

It is not currently approved by the Food and Drug Administration for the treatment of opioid dependence, but Alkermes has submitted a supplemental new drug application for that indication. The application has been designated as a priority review, “which means we're on an accelerated timetable and we're one step closer to making this treatment option available to patients with opioid dependence.” Dr. David R. Gastfriend, vice president for scientific communications at Alkermes, said at a press telebriefing held during the American Psychiatric Association's annual meeting in New Orleans.

He called opioid dependence a growing public health crisis in the United States. “The number of Americans addicted to prescription opioids or heroin has more than doubled since the year 2000,” he said. “There are now more than 1.3 million American adults who are opioid dependent.”

For the study, 250 patients who had completed an opioid detoxification within the previous week and were off all opioids for at least 7 days were randomized to 24 weeks of double-blind treatment with monthly injectable naltrexone 380 mg or to placebo.

The primary efficacy outcome was the response profile based on the rate of urine screening results negative for opioids during the last 20 weeks of the treatment period. Secondary outcomes included retention, physiologic evidence of opioid dependence per naloxone challenge, and a visual analog scale (VAS) of craving.

The mean age of study participants was 30 years and 88% were male. Dr. Gastfriend reported that a significantly higher proportion of patients in the injectable naltrexone group had opioid-negative urine screenings during the final 20 weeks of double-blind treatment compared with patients in the placebo group (90% vs. 35%, respectively). A higher proportion of them also tended to stay in treatment for the entire 24 weeks compared with those in the placebo group (53% vs. 38%).

Other differences that significantly favored the naltrexone group over the placebo group were the incidence of positive naloxone challenge and reductions in the VAS craving score. “Patients on placebo continued to crave opioids throughout the study at the same level that they started with at baseline,” Dr. Gastfriend noted.

“In contrast, the patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level, and that was maintained throughout the study.”

No significant differences between the groups were observed in the incidence of clinical adverse events, and no severe adverse events or premature discontinuations attributable to adverse events occurred in the naltrexone group.

The most common adverse events experienced by patients in the naltrexone group were nasopharyngitis and insomnia.

“We believe these are compelling clinical data,” Dr. Gastfriend concluded. “Extended-release naltrexone may provide patients and physicians with a new treatment option: a non-addictive, once-monthly treatment for opioid dependence.”

The study, which was presented during a poster session at the meeting, was funded by Alkermes Inc. Dr. Gastfriend is a full-time employee of the company.

'Patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level.'

Source DR. GASTFRIEND

Once-monthly treatment with extended-release injectable naltrexone helped patients who were dependent on opioids maintain an opioid-free state after detoxification, results from a placebo-controlled study demonstrated.

After 24 weeks of treatment, patients in the naltrexone treatment group had significant improvements compared with the placebo group in reduced opioid use, craving, and improved treatment retention.

Extended-release injectable naltrexone, marketed by Alkermes Inc. as Vivitrol, is an opioid antagonist administered once monthly by intramuscular injection and is approved in the United States for the treatment of alcohol dependence.

It is not currently approved by the Food and Drug Administration for the treatment of opioid dependence, but Alkermes has submitted a supplemental new drug application for that indication. The application has been designated as a priority review, “which means we're on an accelerated timetable and we're one step closer to making this treatment option available to patients with opioid dependence.” Dr. David R. Gastfriend, vice president for scientific communications at Alkermes, said at a press telebriefing held during the American Psychiatric Association's annual meeting in New Orleans.

He called opioid dependence a growing public health crisis in the United States. “The number of Americans addicted to prescription opioids or heroin has more than doubled since the year 2000,” he said. “There are now more than 1.3 million American adults who are opioid dependent.”

For the study, 250 patients who had completed an opioid detoxification within the previous week and were off all opioids for at least 7 days were randomized to 24 weeks of double-blind treatment with monthly injectable naltrexone 380 mg or to placebo.

The primary efficacy outcome was the response profile based on the rate of urine screening results negative for opioids during the last 20 weeks of the treatment period. Secondary outcomes included retention, physiologic evidence of opioid dependence per naloxone challenge, and a visual analog scale (VAS) of craving.

The mean age of study participants was 30 years and 88% were male. Dr. Gastfriend reported that a significantly higher proportion of patients in the injectable naltrexone group had opioid-negative urine screenings during the final 20 weeks of double-blind treatment compared with patients in the placebo group (90% vs. 35%, respectively). A higher proportion of them also tended to stay in treatment for the entire 24 weeks compared with those in the placebo group (53% vs. 38%).

Other differences that significantly favored the naltrexone group over the placebo group were the incidence of positive naloxone challenge and reductions in the VAS craving score. “Patients on placebo continued to crave opioids throughout the study at the same level that they started with at baseline,” Dr. Gastfriend noted.

“In contrast, the patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level, and that was maintained throughout the study.”

No significant differences between the groups were observed in the incidence of clinical adverse events, and no severe adverse events or premature discontinuations attributable to adverse events occurred in the naltrexone group.

The most common adverse events experienced by patients in the naltrexone group were nasopharyngitis and insomnia.

“We believe these are compelling clinical data,” Dr. Gastfriend concluded. “Extended-release naltrexone may provide patients and physicians with a new treatment option: a non-addictive, once-monthly treatment for opioid dependence.”

The study, which was presented during a poster session at the meeting, was funded by Alkermes Inc. Dr. Gastfriend is a full-time employee of the company.

'Patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level.'

Source DR. GASTFRIEND

Once-monthly treatment with extended-release injectable naltrexone helped patients who were dependent on opioids maintain an opioid-free state after detoxification, results from a placebo-controlled study demonstrated.

After 24 weeks of treatment, patients in the naltrexone treatment group had significant improvements compared with the placebo group in reduced opioid use, craving, and improved treatment retention.

Extended-release injectable naltrexone, marketed by Alkermes Inc. as Vivitrol, is an opioid antagonist administered once monthly by intramuscular injection and is approved in the United States for the treatment of alcohol dependence.

It is not currently approved by the Food and Drug Administration for the treatment of opioid dependence, but Alkermes has submitted a supplemental new drug application for that indication. The application has been designated as a priority review, “which means we're on an accelerated timetable and we're one step closer to making this treatment option available to patients with opioid dependence.” Dr. David R. Gastfriend, vice president for scientific communications at Alkermes, said at a press telebriefing held during the American Psychiatric Association's annual meeting in New Orleans.

He called opioid dependence a growing public health crisis in the United States. “The number of Americans addicted to prescription opioids or heroin has more than doubled since the year 2000,” he said. “There are now more than 1.3 million American adults who are opioid dependent.”

For the study, 250 patients who had completed an opioid detoxification within the previous week and were off all opioids for at least 7 days were randomized to 24 weeks of double-blind treatment with monthly injectable naltrexone 380 mg or to placebo.

The primary efficacy outcome was the response profile based on the rate of urine screening results negative for opioids during the last 20 weeks of the treatment period. Secondary outcomes included retention, physiologic evidence of opioid dependence per naloxone challenge, and a visual analog scale (VAS) of craving.

The mean age of study participants was 30 years and 88% were male. Dr. Gastfriend reported that a significantly higher proportion of patients in the injectable naltrexone group had opioid-negative urine screenings during the final 20 weeks of double-blind treatment compared with patients in the placebo group (90% vs. 35%, respectively). A higher proportion of them also tended to stay in treatment for the entire 24 weeks compared with those in the placebo group (53% vs. 38%).

Other differences that significantly favored the naltrexone group over the placebo group were the incidence of positive naloxone challenge and reductions in the VAS craving score. “Patients on placebo continued to crave opioids throughout the study at the same level that they started with at baseline,” Dr. Gastfriend noted.

“In contrast, the patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level, and that was maintained throughout the study.”

No significant differences between the groups were observed in the incidence of clinical adverse events, and no severe adverse events or premature discontinuations attributable to adverse events occurred in the naltrexone group.

The most common adverse events experienced by patients in the naltrexone group were nasopharyngitis and insomnia.

“We believe these are compelling clinical data,” Dr. Gastfriend concluded. “Extended-release naltrexone may provide patients and physicians with a new treatment option: a non-addictive, once-monthly treatment for opioid dependence.”

The study, which was presented during a poster session at the meeting, was funded by Alkermes Inc. Dr. Gastfriend is a full-time employee of the company.

'Patients on extended-release naltrexone had a rapid decline in craving to half of their baseline level.'

Source DR. GASTFRIEND

SAN DIEGO — The way Dr. Geoffrey T. Manley sees it, the classification of traumatic brain injury needs an extreme makeover.

For the past 35 years, clinicians have relied on symptomatology from the Glasgow Coma Scale (GCS) to classify traumatic brain injuries (TBIs) as mild, moderate, or severe, but such emphasis on symptoms “misses the point,” Dr. Manley, chief of neurotrauma and vice chairman of the department of neurosurgery at the University of California, San Francisco, said at the meeting.

“The brain is not like the heart, where if you lose a certain percentage of your heart muscle then you'll have an unexpected reduction in cardiac function. The brain is a unique organ in that it's an organ of functional connectivity. You can have very small lesions in discreet pathways, which can have a phenomenal impact on outcome. Many of these lesions can only be seen with MRI, which is not routinely used for TBI.”

He went on to note that the GCS was developed “before the advent of CT scans, so this is very old system that we're using.”

In 2007, Dr. Manley and a working group of TBI experts––including Professor Sir Graham Teasdale, who developed the GCS—convened to explore the potential for improving TBI classification (J. Neurotrauma 2008;25:719-38). It became clear to the group, Dr. Manley said, “that if we were going to try to change the field, we were going to have to start defining a common set of data elements and technical standards so that we could be able to collect the same information on patients from site to site and to make sure that assessment tools are applied in the same way.”

Common data elements are needed in TBI research “because accurate collection of structured data is essential, especially if you want to do meta-analyses and if you want to share data,” he added. “It reduces time, cost, and effort of initiating clinical trials and provides opportunities for lessons learned and best practices, even if a trial isn't considered successful.”

The group's recommendations call for the following:

▸ Broaden TBI trials to include less severely injured patients.

▸ Improve CT imaging classification. “The systems that we use now are different from hospital to hospital and radiologist to radiologist,” Dr. Manley said. “There is no standardization.”

▸ Increase use of early MRI. “Many of us have seen a lot of value in using MRIs,” he said. “We will get an MRI on a stroke patient in a moment, but we almost never get an MRI in a TBI patient. This is a cultural change that needs to happen in this field.”

▸ Examine phase II trials and surrogate end points more closely. TBI patients “have such a long recovery: an injury, an acute hospitalization, rehabilitation, and then you look at an outcome at 6 months or a year,” he said. “Lots of things happen during that time period.”

▸ Develop more complex statistical and bioinformatics tools. TBI studies “aren't like cancer studies,” he said. “You can't phenotype these patients as well as you can in studies of other diseases. We need some novel statistical methods to deal with the realities of studying these patients with life-threatening diseases.”

In March 2009, Dr. Manley and about 160 other representatives from 49 agencies and institutes, including the Department of Defense, the Department of Education, and the National Institute of Neurological Disorders and Stroke convened in Washington to begin an unprecedented effort to develop standards for TBI data collection and to better define and classify TBI.

The experts were divided into numerous work groups charged with assembling white papers on specific areas of TBI research, including demographics and acute clinical assessment, biospecimens and biomarkers, neuroimaging, posttraumatic stress disorder, and outcome measures. White papers from the various work groups will be published later in 2010, and the TBI Common Data Elements will be available online at www.nindscommondataelements.org

The next step in this multidisciplinary effort is to establish a prospective, multivariate TBI database to validate common data elements, including a contemporary snapshot of TBI and treatment and a cross-sectional overview of patients. “So rather than saying we're looking at patients with severe, moderate, or mild injury, we're going to be agnostic to [the label of] mild, moderate, and severe, and we'll look across the entire spectrum of injury,” Dr. Manley explained.

The database “will also allow the researchers to validate prognostic models, establish process indicators, and develop improved TBI classification,” he said.

Dr. Manley and his colleagues were recently awarded a National Institutes of Health Grand Opportunities Challenge Grant to pilot this effort. The global goal is to develop, test, and refine standards for data collection in TBI studies in a multi-center observational study of 1,000 patients at high-volume TBI centers, including UCSF; the University of Pittsburgh; Mount Sinai School of Medicine, New York; and Seton Hospital in Austin, Texas. Dr. Andrew Maas, of University Hospital Antwerp, Brussels, is leading a European group of TBI investigators that also will be contributing to this effort.

“If we really want to transform TBI research, we're going to have to work in multidisciplinary teams,” Dr. Manley concluded. “We need this infrastructure. We need the appropriate collaboration and tools.”

Disclosures: Dr. Manley had no relevant financial conflicts.

'If we really want to transform TBI research, we're going to have to work on multidisciplinary teams.'

Source DR. MANLEY

SAN DIEGO — The way Dr. Geoffrey T. Manley sees it, the classification of traumatic brain injury needs an extreme makeover.

For the past 35 years, clinicians have relied on symptomatology from the Glasgow Coma Scale (GCS) to classify traumatic brain injuries (TBIs) as mild, moderate, or severe, but such emphasis on symptoms “misses the point,” Dr. Manley, chief of neurotrauma and vice chairman of the department of neurosurgery at the University of California, San Francisco, said at the meeting.

“The brain is not like the heart, where if you lose a certain percentage of your heart muscle then you'll have an unexpected reduction in cardiac function. The brain is a unique organ in that it's an organ of functional connectivity. You can have very small lesions in discreet pathways, which can have a phenomenal impact on outcome. Many of these lesions can only be seen with MRI, which is not routinely used for TBI.”

He went on to note that the GCS was developed “before the advent of CT scans, so this is very old system that we're using.”

In 2007, Dr. Manley and a working group of TBI experts––including Professor Sir Graham Teasdale, who developed the GCS—convened to explore the potential for improving TBI classification (J. Neurotrauma 2008;25:719-38). It became clear to the group, Dr. Manley said, “that if we were going to try to change the field, we were going to have to start defining a common set of data elements and technical standards so that we could be able to collect the same information on patients from site to site and to make sure that assessment tools are applied in the same way.”

Common data elements are needed in TBI research “because accurate collection of structured data is essential, especially if you want to do meta-analyses and if you want to share data,” he added. “It reduces time, cost, and effort of initiating clinical trials and provides opportunities for lessons learned and best practices, even if a trial isn't considered successful.”

The group's recommendations call for the following:

▸ Broaden TBI trials to include less severely injured patients.

▸ Improve CT imaging classification. “The systems that we use now are different from hospital to hospital and radiologist to radiologist,” Dr. Manley said. “There is no standardization.”

▸ Increase use of early MRI. “Many of us have seen a lot of value in using MRIs,” he said. “We will get an MRI on a stroke patient in a moment, but we almost never get an MRI in a TBI patient. This is a cultural change that needs to happen in this field.”

▸ Examine phase II trials and surrogate end points more closely. TBI patients “have such a long recovery: an injury, an acute hospitalization, rehabilitation, and then you look at an outcome at 6 months or a year,” he said. “Lots of things happen during that time period.”

▸ Develop more complex statistical and bioinformatics tools. TBI studies “aren't like cancer studies,” he said. “You can't phenotype these patients as well as you can in studies of other diseases. We need some novel statistical methods to deal with the realities of studying these patients with life-threatening diseases.”

In March 2009, Dr. Manley and about 160 other representatives from 49 agencies and institutes, including the Department of Defense, the Department of Education, and the National Institute of Neurological Disorders and Stroke convened in Washington to begin an unprecedented effort to develop standards for TBI data collection and to better define and classify TBI.

The experts were divided into numerous work groups charged with assembling white papers on specific areas of TBI research, including demographics and acute clinical assessment, biospecimens and biomarkers, neuroimaging, posttraumatic stress disorder, and outcome measures. White papers from the various work groups will be published later in 2010, and the TBI Common Data Elements will be available online at www.nindscommondataelements.org

The next step in this multidisciplinary effort is to establish a prospective, multivariate TBI database to validate common data elements, including a contemporary snapshot of TBI and treatment and a cross-sectional overview of patients. “So rather than saying we're looking at patients with severe, moderate, or mild injury, we're going to be agnostic to [the label of] mild, moderate, and severe, and we'll look across the entire spectrum of injury,” Dr. Manley explained.

The database “will also allow the researchers to validate prognostic models, establish process indicators, and develop improved TBI classification,” he said.

Dr. Manley and his colleagues were recently awarded a National Institutes of Health Grand Opportunities Challenge Grant to pilot this effort. The global goal is to develop, test, and refine standards for data collection in TBI studies in a multi-center observational study of 1,000 patients at high-volume TBI centers, including UCSF; the University of Pittsburgh; Mount Sinai School of Medicine, New York; and Seton Hospital in Austin, Texas. Dr. Andrew Maas, of University Hospital Antwerp, Brussels, is leading a European group of TBI investigators that also will be contributing to this effort.

“If we really want to transform TBI research, we're going to have to work in multidisciplinary teams,” Dr. Manley concluded. “We need this infrastructure. We need the appropriate collaboration and tools.”

Disclosures: Dr. Manley had no relevant financial conflicts.

'If we really want to transform TBI research, we're going to have to work on multidisciplinary teams.'

Source DR. MANLEY

SAN DIEGO — The way Dr. Geoffrey T. Manley sees it, the classification of traumatic brain injury needs an extreme makeover.

For the past 35 years, clinicians have relied on symptomatology from the Glasgow Coma Scale (GCS) to classify traumatic brain injuries (TBIs) as mild, moderate, or severe, but such emphasis on symptoms “misses the point,” Dr. Manley, chief of neurotrauma and vice chairman of the department of neurosurgery at the University of California, San Francisco, said at the meeting.

“The brain is not like the heart, where if you lose a certain percentage of your heart muscle then you'll have an unexpected reduction in cardiac function. The brain is a unique organ in that it's an organ of functional connectivity. You can have very small lesions in discreet pathways, which can have a phenomenal impact on outcome. Many of these lesions can only be seen with MRI, which is not routinely used for TBI.”

He went on to note that the GCS was developed “before the advent of CT scans, so this is very old system that we're using.”

In 2007, Dr. Manley and a working group of TBI experts––including Professor Sir Graham Teasdale, who developed the GCS—convened to explore the potential for improving TBI classification (J. Neurotrauma 2008;25:719-38). It became clear to the group, Dr. Manley said, “that if we were going to try to change the field, we were going to have to start defining a common set of data elements and technical standards so that we could be able to collect the same information on patients from site to site and to make sure that assessment tools are applied in the same way.”

Common data elements are needed in TBI research “because accurate collection of structured data is essential, especially if you want to do meta-analyses and if you want to share data,” he added. “It reduces time, cost, and effort of initiating clinical trials and provides opportunities for lessons learned and best practices, even if a trial isn't considered successful.”

The group's recommendations call for the following:

▸ Broaden TBI trials to include less severely injured patients.

▸ Improve CT imaging classification. “The systems that we use now are different from hospital to hospital and radiologist to radiologist,” Dr. Manley said. “There is no standardization.”

▸ Increase use of early MRI. “Many of us have seen a lot of value in using MRIs,” he said. “We will get an MRI on a stroke patient in a moment, but we almost never get an MRI in a TBI patient. This is a cultural change that needs to happen in this field.”

▸ Examine phase II trials and surrogate end points more closely. TBI patients “have such a long recovery: an injury, an acute hospitalization, rehabilitation, and then you look at an outcome at 6 months or a year,” he said. “Lots of things happen during that time period.”

▸ Develop more complex statistical and bioinformatics tools. TBI studies “aren't like cancer studies,” he said. “You can't phenotype these patients as well as you can in studies of other diseases. We need some novel statistical methods to deal with the realities of studying these patients with life-threatening diseases.”

In March 2009, Dr. Manley and about 160 other representatives from 49 agencies and institutes, including the Department of Defense, the Department of Education, and the National Institute of Neurological Disorders and Stroke convened in Washington to begin an unprecedented effort to develop standards for TBI data collection and to better define and classify TBI.

The experts were divided into numerous work groups charged with assembling white papers on specific areas of TBI research, including demographics and acute clinical assessment, biospecimens and biomarkers, neuroimaging, posttraumatic stress disorder, and outcome measures. White papers from the various work groups will be published later in 2010, and the TBI Common Data Elements will be available online at www.nindscommondataelements.org

The next step in this multidisciplinary effort is to establish a prospective, multivariate TBI database to validate common data elements, including a contemporary snapshot of TBI and treatment and a cross-sectional overview of patients. “So rather than saying we're looking at patients with severe, moderate, or mild injury, we're going to be agnostic to [the label of] mild, moderate, and severe, and we'll look across the entire spectrum of injury,” Dr. Manley explained.

The database “will also allow the researchers to validate prognostic models, establish process indicators, and develop improved TBI classification,” he said.

Dr. Manley and his colleagues were recently awarded a National Institutes of Health Grand Opportunities Challenge Grant to pilot this effort. The global goal is to develop, test, and refine standards for data collection in TBI studies in a multi-center observational study of 1,000 patients at high-volume TBI centers, including UCSF; the University of Pittsburgh; Mount Sinai School of Medicine, New York; and Seton Hospital in Austin, Texas. Dr. Andrew Maas, of University Hospital Antwerp, Brussels, is leading a European group of TBI investigators that also will be contributing to this effort.

“If we really want to transform TBI research, we're going to have to work in multidisciplinary teams,” Dr. Manley concluded. “We need this infrastructure. We need the appropriate collaboration and tools.”

Disclosures: Dr. Manley had no relevant financial conflicts.

'If we really want to transform TBI research, we're going to have to work on multidisciplinary teams.'

Source DR. MANLEY

Major Finding: The specificity of a new screening approach developed for postmenopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single-arm, prospective, multicenter study of 3,252 women aged 50-74 years.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast Jr., disclosed that he serves as a consultant and adviser to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to the results of a single-arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said during a press briefing sponsored by the society.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, which was presented at the annual meeting of ASCO in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years, the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” Dr. Lu said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

Major Finding: The specificity of a new screening approach developed for postmenopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single-arm, prospective, multicenter study of 3,252 women aged 50-74 years.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast Jr., disclosed that he serves as a consultant and adviser to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to the results of a single-arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said during a press briefing sponsored by the society.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, which was presented at the annual meeting of ASCO in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years, the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” Dr. Lu said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

Major Finding: The specificity of a new screening approach developed for postmenopausal women at average risk for ovarian cancer was 99.9%.

Data Source: A single-arm, prospective, multicenter study of 3,252 women aged 50-74 years.

Disclosures: One of the study authors, Dr. Herbert A. Fritsche, disclosed that he received research funding from Roche Diagnostics. Another study author, Dr. Robert C. Bast Jr., disclosed that he serves as a consultant and adviser to Fujiresio Diagnostics, Inc. He also receives other remuneration and royalties for helping to invent the CA-125 assay.

A staged algorithm that incorporates the CA-125 assay to screen postmenopausal women for ovarian cancer has a near-perfect specificity of 99.9%, according to the results of a single-arm, multicenter study that enrolled more than 3,200 women at average risk of the disease.

If confirmed in larger studies, this approach could be used to detect ovarian cancer in its early, more curable stages, lead author Dr. Karen Lu said during a press briefing sponsored by the society.

“Ovarian cancer is the most lethal gynecologic cancer,” said Dr. Lu, professor of gynecologic oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“Greater than 75% of cases present with advanced stage disease, when cure rates are less than 30%. If caught at an early stage, cure rates are 60%-90%, but at the current time there are no effective screening methods.”

For the 9-year study, which was presented at the annual meeting of ASCO in Chicago, Dr. Lu and her associates enrolled 3,252 women aged 50-74 years with no significant family history of breast or ovarian cancer to be screened with the Risk of Ovarian Cancer Algorithm (ROCA). She described ROCA as a mathematical model that takes into account a woman's age as well as changes in the values of her CA-125 assay over time.

“From here there are three possibilities,” she explained. “Those individuals who have a low ROCA score are told to come back at 1 year for a repeat CA-125. Those who have an intermediate ROCA score are told to come back at 3 months for another CA-125, and those who have a high ROCA score are triaged to a transvaginal ultrasound and referral to a gynecologic oncologist.”

After following the women for 9 years, the researchers found that the average annual rate of referral for CA-125 assays every 3 months was 6.8% and that the average annual rate of transvaginal ultrasound and referral to a gynecologic oncologist was only 0.9%. “Each year the overwhelming majority of women were triaged to the low-risk category—an annual CA-125,” Dr. Lu said.

Cumulatively, 85 women (2.6%) received transvaginal ultrasound and subsequent referral to a gynecologic oncologist. Of these, eight required surgery: three for invasive ovarian cancers (two stage 1C and one stage IIB), two for borderline ovarian tumors, and three for benign ovarian tumors. This translated into a positive predictive value of 37.5%. “This means that three operations would be necessary to detect one case of invasive ovarian cancer,” Dr. Lu said.

The combined specificity of ROCA followed by transvaginal ultrasound was 99.9%, “which means that there were very few false positive.”

Dr. Lu emphasized that while results of the ROCA screening strategy are encouraging, “they are not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that uses mortality as an end point, and uses the same ROCA algorithm.” That trial of more than 200,000 women is underway in the United Kingdom, she said. Results are expected in 2015.

ASCO President Douglas W. Blayney said that the ROCA algorithm “represents yet another example of personalized medicine. Here, we have a personalized screening strategy for a vicious type of cancer. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and technologically somewhat difficult to interpret. Here, we have a staged application.”

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

SAN DIEGO — Women who go through menopause before the age of 46 are twice as likely to have a heart attack, stroke, or other cardiovascular event later in life as are women who do not go through early menopause, results from a large, multiethnic study showed.

“Our study is observational, so we cannot conclude that early menopause somehow causes these cardiovascular disease events, but our findings support using early menopause as a marker of increased cardiovascular disease risk,” Dr. Melissa F. Wellons said during a press briefing at the meeting. “Therefore, getting clinicians to ask women about menopause and about when they went through menopause is an important part of potentially determining what their risk of CVD is in the future. Doing that can give them information on placing these women with early menopause into a higher risk group and counseling them appropriately, such as encouraging them to stop smoking, exercise, and lose weight.”

Dr. Wellons, a fellow in the department of medicine at the University of Alabama, Birmingham, and her associates evaluated data from 2,509 women enrolled in the observational Multi-Ethnic Study of Atherosclerosis (MESA), funded by the National Institutes of Health. It included more than 6,000 women, from six communities in the United States, who were recruited in 2000 and followed for an average of 7 years. Most (40%) were white, 25% were black, 22% were Hispanic, and 13% were Chinese American.

The researchers defined early menopause as occurring before age 46, either naturally or surgically through removal of both ovaries, and they tracked the incidence of CVD among all study participants. This included heart attack, nonfatal cardiac arrest, a definite angina, probable angina (if followed by revascularization), a stroke, or death due to stroke, heart attack, or other cardiovascular disease.

At baseline, the women ranged in age from 45 to 84 years. Of the 2,509 women, 693 (28%) reported early menopause. Of these, 446 (64%) had natural menopause and 247 (36%) had surgical menopause.

In the early menopause group, 41 women (5.9%) had CVD events during the study period. Among those who did not have early menopause, 47 women (2.6%), had CVD events. The difference was significant.

No woman in either group had a CVD event before the age of 55.

After adjusting for race/ethnicity, level of education, smoking history, hypertension, total cholesterol, HDL cholesterol, diabetes, and whether the menopause was natural or surgical, Dr. Wellons and her associates found that women in the early menopause group were 2.1 times more likely to experience a CVD event, compared with women who did not have early menopause. Further adjustment for current or previous use of hormone replacement therapy and body mass index produced identical results.

Dr. Wellons was the recipient of an NHLBI Career Development Award.

'Our findings support using early menopause as a marker of increased cardiovascular disease risk.'

Source DR. WELLONS

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101° F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing at the annual meeting of the Endocrine Society.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they needed to take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101° F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded.

“We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

We primarily cool ourselves by sweating, and diabetes patients may have an impaired ability to do so.

Source DR. NASSAR

It's important for people with diabetes to stay hydrated when temperatures rise.

Source ©Dana Heinemann/Fotolia.com

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101° F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing at the annual meeting of the Endocrine Society.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they needed to take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101° F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded.

“We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

We primarily cool ourselves by sweating, and diabetes patients may have an impaired ability to do so.

Source DR. NASSAR

It's important for people with diabetes to stay hydrated when temperatures rise.

Source ©Dana Heinemann/Fotolia.com

Major Finding: Nearly one-third of patients with diabetes who live in a hot climate (29%) did not initiate personal protective measures for self-management of their disease until temperatures reached 101°F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

Data Source: A survey of 152 adult patients with diabetes at the Mayo Clinic, Scottsdale, Ariz.

Disclosures: Dr. Nassar said that she had no conflicts to disclose.

SAN DIEGO — Many adults with diabetes who live in a hot climate don't understand how hot weather impacts their disease self-management, results from a survey of 152 patients demonstrated.

For example, 29% of respondents did not initiate personal protective measures until temperatures reached 101° F, and 37% left their diabetes medications and supplies at home rather than risking them to heat exposure.

“This was quite concerning, because they wouldn't have the means to check their blood sugars if they began to feel faint if they got behind the wheel to start driving; or if they needed to seek medical attention, they wouldn't have the means to know if they should,” Dr. Adrienne Nassar said during a press briefing at the annual meeting of the Endocrine Society.

Previous studies have shown that people with diabetes have higher rates of emergency room visits, hospitalizations, and deaths caused by heat illness during hot weather than during more temperate weather, but few published studies have assessed how patients manage their disease during extremely hot temperatures, said Dr. Nassar, a third-year resident in the department of internal medicine at Mayo Clinic, Scottsdale, Ariz.

“Furthermore, the number of diabetes cases is increasing in the Southwestern United States,” she said. “From a physiologic standpoint, the primary way in which we cool ourselves is through sweating, and diabetes patients may have an impaired ability to do so.”

In collaboration with the National Weather Service and the National Oceanic and Atmospheric Administration, Dr. Nassar and her associates surveyed 152 adults who attended the diabetes clinic at Mayo between Nov. 30, 2009, and Dec. 31, 2009, to assess the types of personal protective measures they needed to take against the heat, as well as their knowledge of safe temperatures and exposure times.

The mean age of respondents was 64 years, 51% were female, 58% were non-Hispanic white, 83% had type 2 diabetes, and 77% used insulin.

More than half of the patients (60%) reported staying indoors to protect themselves against the heat, 56% drank fluids frequently, 45% applied sunscreen, and 45% wore protective clothing. However, 23% reported drinking only when they became thirsty, suggesting that they “were starting to get behind on their fluid status,” Dr. Nassar said.

Nearly three-quarters of patients (71%) reported spending less than 1 hour in the heat, but 29% did not initiate personal protective measures until temperatures reached 101° F. “Heat-related illness can take place at 80°-90° when you factor in the heat index,” Dr. Nassar noted.

While 73% of patients said they had received information about the harmful effects of heat on insulin, fewer indicated that they had received information about extreme heat on glucose meters (41%), oral medications (39%), and glucose testing strips (38%), and 20% “did not know when to begin [taking precautions], although this information is included in the product information inserts [contained in packaging for] medications and glucose meters,” she said.

In addition, 37% of patients left their diabetes medications and supplies at home during hot days, rather than risk them to heat exposure.

Patients reported television as their primary source for weather information (89%), followed by radio, the Internet, and newspapers.

“Overall, we found that many patients expose themselves to high temperatures before initiating protective measures,” Dr. Nassar concluded.

“We would like to repeat our survey in other populations, for example, outdoor laborers [who may employ unique protective strategies], adolescents, younger adults, and different socioeconomic groups.”

The study is expected to appear in the September 2010 issue of the Journal of Diabetes Science and Technology.

We primarily cool ourselves by sweating, and diabetes patients may have an impaired ability to do so.

Source DR. NASSAR

It's important for people with diabetes to stay hydrated when temperatures rise.

Source ©Dana Heinemann/Fotolia.com

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myocardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up. Kaiser Permanente Northern California is a large integrated health care delivery system with more than 3 million members, noted the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

“Previous studies of the incidence of myocardial infarction and case fatality rates have often focused on selected subgroups (e.g., the elderly) in populations with limited diversity with respect to race and ethnic group, age, sex, and coexisting conditions, and most have not examined ST-segment elevation [MI] separately, although the management and outcomes of these entities differ markedly,” Dr. Yeh and his associates wrote. “The increased use of highly sensitive cardiac biomarkers, particularly troponin, over time might also have contributed to both an artifactually higher incidence of myocardial infarction and a lower level of severity among diagnosed cases.”

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008. This represented a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter.

Adjusted 30-day mortality decreased significantly from 1999 to 2008 among patients with non-STEMI (OR, 0.82) but did not change significantly among those with STEMI (OR, 0.93).

The researchers said that the declining incidence of MI in the study population can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking,” Dr. Yeh and his associates wrote.

In an editorial, Jeremiah R. Brown, Ph.D., and Gerald T. O'Connor, Ph.D., Sc.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., noted that U.S. clinicians are succeeding in preventing coronary heart disease by “reducing the burden of modifiable risk factors, such as smoking, hypertension, and high cholesterol levels,” but diabetes and obesity are becoming more prevalent (N. Engl. J. Med. 2010;362:2150-3).

“Despite the availability of statins and other pharmacologic agents … to modify the risk factors for coronary heart disease,” they continued, “the rate of improvement has slowed down or stopped … As a nation, we are not making prevention a priority in our hospitals, clinics, schools, or communities.”

Dr. Yeh and his associates acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.”

They also noted that the study results “may not be fully generalizable to other health care settings,” considering Kaiser's integrated model of health care delivery.

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myocardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up. Kaiser Permanente Northern California is a large integrated health care delivery system with more than 3 million members, noted the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

“Previous studies of the incidence of myocardial infarction and case fatality rates have often focused on selected subgroups (e.g., the elderly) in populations with limited diversity with respect to race and ethnic group, age, sex, and coexisting conditions, and most have not examined ST-segment elevation [MI] separately, although the management and outcomes of these entities differ markedly,” Dr. Yeh and his associates wrote. “The increased use of highly sensitive cardiac biomarkers, particularly troponin, over time might also have contributed to both an artifactually higher incidence of myocardial infarction and a lower level of severity among diagnosed cases.”

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008. This represented a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter.

Adjusted 30-day mortality decreased significantly from 1999 to 2008 among patients with non-STEMI (OR, 0.82) but did not change significantly among those with STEMI (OR, 0.93).

The researchers said that the declining incidence of MI in the study population can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking,” Dr. Yeh and his associates wrote.

In an editorial, Jeremiah R. Brown, Ph.D., and Gerald T. O'Connor, Ph.D., Sc.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., noted that U.S. clinicians are succeeding in preventing coronary heart disease by “reducing the burden of modifiable risk factors, such as smoking, hypertension, and high cholesterol levels,” but diabetes and obesity are becoming more prevalent (N. Engl. J. Med. 2010;362:2150-3).

“Despite the availability of statins and other pharmacologic agents … to modify the risk factors for coronary heart disease,” they continued, “the rate of improvement has slowed down or stopped … As a nation, we are not making prevention a priority in our hospitals, clinics, schools, or communities.”

Dr. Yeh and his associates acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.”

They also noted that the study results “may not be fully generalizable to other health care settings,” considering Kaiser's integrated model of health care delivery.

Major Finding: The age- and sex-adjusted incidence of acute MI decreased by 24% between 1999 and 2008.

Data Source: A study of 46,086 Kaiser Permanente Northern California members aged 30 years and older who were hospitalized with a primary discharge diagnosis of acute MI.

Disclosures: The study was supported by funding from the Permanente Medical Group and by a Schering-Plough Future Leaders in Cardiovascular Medical Research grant. Three of the study authors are employed by Permanente Medical Group.

The incidence of myocardial infarction declined by 24% between 1999 and 2008, and the decline was most significant among those with ST-segment elevation myocardial infarction, according to findings from a large community-based population study.

In addition, 30-day mortality rates improved, driven mostly by declining case fatality rates among patients with non–ST-segment elevation myocardial infarction (non-STEMI).

Researchers identified 46,086 members of Kaiser Permanente Northern California aged 30 years and older who were hospitalized between 1999 and 2008 with a primary discharge diagnosis of acute MI. The 46,086 hospitalizations represented 18,691,131 person-years of follow-up. Kaiser Permanente Northern California is a large integrated health care delivery system with more than 3 million members, noted the researchers, led by Dr. Robert W. Yeh of the department of medicine at Massachusetts General Hospital, Boston.

The researchers used ICD-9-CM codes to classify MI hospitalizations as STEMI or non-STEMI and to calculate age- and sex-adjusted incidence rates. They used administrative databases, state death data, and Social Security Administration data to determine 30-day mortality, and also identified patient characteristics, outpatient medications, and levels of cardiac biomarkers during hospitalization (N. Engl. J. Med. 2010;362:2155-65).

“Previous studies of the incidence of myocardial infarction and case fatality rates have often focused on selected subgroups (e.g., the elderly) in populations with limited diversity with respect to race and ethnic group, age, sex, and coexisting conditions, and most have not examined ST-segment elevation [MI] separately, although the management and outcomes of these entities differ markedly,” Dr. Yeh and his associates wrote. “The increased use of highly sensitive cardiac biomarkers, particularly troponin, over time might also have contributed to both an artifactually higher incidence of myocardial infarction and a lower level of severity among diagnosed cases.”

After adjustment for age and sex, the overall incidence of MI rose from 274 cases per 100,000 person-years in 1999 to 287 cases per 100,000 person-years in 2000, then fell each year thereafter, reaching 208 per 100,000 person-years in 2008. This represented a significant 24% decrease over the study period. In addition, 30-day mortality after acute MI was significantly lower in 2008 than in 1999 (adjusted odds ratio, 0.76).

The incidence of age- and sex-adjusted STEMI decreased each year, from 133 per 100,000 person-years in 1999 to 50 per 100,000 person-years in 2008, a decline of 62%. However, the incidence of non-STEMI increased from 155 cases per 100,000 person-years in 1999 to 202 cases per 100,000 person-years in 2004, the year that use of troponin testing stabilized, and decreased thereafter.

Adjusted 30-day mortality decreased significantly from 1999 to 2008 among patients with non-STEMI (OR, 0.82) but did not change significantly among those with STEMI (OR, 0.93).

The researchers said that the declining incidence of MI in the study population can be attributed at least in part to “substantial improvements in primary-prevention efforts” implemented at Kaiser. The decline occurred “despite the increased sensitivity of new biomarkers for the diagnosis of myocardial infarction” and the increasing prevalence of obesity and diabetes. The increased use of troponin testing would be expected to increase the incidence of MI, so “the observed decreases in myocardial infarction since 2000 are even more striking,” Dr. Yeh and his associates wrote.

In an editorial, Jeremiah R. Brown, Ph.D., and Gerald T. O'Connor, Ph.D., Sc.D., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., noted that U.S. clinicians are succeeding in preventing coronary heart disease by “reducing the burden of modifiable risk factors, such as smoking, hypertension, and high cholesterol levels,” but diabetes and obesity are becoming more prevalent (N. Engl. J. Med. 2010;362:2150-3).

“Despite the availability of statins and other pharmacologic agents … to modify the risk factors for coronary heart disease,” they continued, “the rate of improvement has slowed down or stopped … As a nation, we are not making prevention a priority in our hospitals, clinics, schools, or communities.”

Dr. Yeh and his associates acknowledged certain limitations of their study, including the fact that “the true effect of changes in diagnostic sensitivity with changing biomarker use cannot be comprehensively quantified. However, the expected bias would be an overestimation of the incidence of myocardial infarction in later years. Thus, actual decreases in the incidence of myocardial infarction since 2000 may, in fact, be greater than we observed.”

They also noted that the study results “may not be fully generalizable to other health care settings,” considering Kaiser's integrated model of health care delivery.

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines, contained in a report released May 26, were developed "to avoid complications, contradictions, and confusion," wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, who were led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version "recognizes the new and increased influence" of the National Institutes of Health Guidelines on Human Stem Cell Research released in 2009, and "incorporates references to the NIH guidelines as appropriate."

Where there is complete overlap, the report continues, "the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines."

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. "Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines," the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, "only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding," the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' Guidelines were issued, the Ethics Committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

"Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes," the report notes. "Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines" and recognizes "that states and other entities may choose to set their own policies, as New York has done."

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. "Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies."

The committee, which chose to disband after completion of the current guidelines, called for an "ongoing neutral forum" in which stem cell issues can be discussed.

"Perhaps most needed is a forum that could bring together key stakeholders--including federal, state, academic, patient, and industry organizations and institutions--for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities," they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known under the umbrella name the National Academies.

Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines, contained in a report released May 26, were developed "to avoid complications, contradictions, and confusion," wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, who were led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version "recognizes the new and increased influence" of the National Institutes of Health Guidelines on Human Stem Cell Research released in 2009, and "incorporates references to the NIH guidelines as appropriate."

Where there is complete overlap, the report continues, "the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines."

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. "Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines," the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, "only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding," the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' Guidelines were issued, the Ethics Committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

"Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes," the report notes. "Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines" and recognizes "that states and other entities may choose to set their own policies, as New York has done."

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. "Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies."

The committee, which chose to disband after completion of the current guidelines, called for an "ongoing neutral forum" in which stem cell issues can be discussed.

"Perhaps most needed is a forum that could bring together key stakeholders--including federal, state, academic, patient, and industry organizations and institutions--for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities," they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known under the umbrella name the National Academies.

Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines, contained in a report released May 26, were developed "to avoid complications, contradictions, and confusion," wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, who were led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version "recognizes the new and increased influence" of the National Institutes of Health Guidelines on Human Stem Cell Research released in 2009, and "incorporates references to the NIH guidelines as appropriate."

Where there is complete overlap, the report continues, "the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines."

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. "Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines," the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, "only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding," the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' Guidelines were issued, the Ethics Committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

"Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes," the report notes. "Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines" and recognizes "that states and other entities may choose to set their own policies, as New York has done."

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. "Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies."

The committee, which chose to disband after completion of the current guidelines, called for an "ongoing neutral forum" in which stem cell issues can be discussed.

"Perhaps most needed is a forum that could bring together key stakeholders--including federal, state, academic, patient, and industry organizations and institutions--for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities," they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known under the umbrella name the National Academies.

Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing sponsored by the American Society of Clinical Oncology, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III clinical trial at nine CCOP centers, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping after completing adjuvant therapy for their cancer.

To be eligible, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes met twice a week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher. At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%). In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

The trial was funded by grants from the National Cancer Institute.

The Yoga for Cancer Survivors program encompasses components of hatha yoga and restorative yoga, including postures and mindfulness.

Source ©Noam Armonn/iStockphoto.com

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing sponsored by the American Society of Clinical Oncology, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III clinical trial at nine CCOP centers, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping after completing adjuvant therapy for their cancer.

To be eligible, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes met twice a week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher. At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%). In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

The trial was funded by grants from the National Cancer Institute.

The Yoga for Cancer Survivors program encompasses components of hatha yoga and restorative yoga, including postures and mindfulness.

Source ©Noam Armonn/iStockphoto.com

Yoga, widely practiced for maintaining flexibility and coping with stress, may also benefit cancer survivors who report impaired sleep quality and fatigue, results from a nationwide study demonstrated.

During a press briefing sponsored by the American Society of Clinical Oncology, lead author Karen Mustian, Ph.D., of the University of Rochester (N.Y.) Medical Center, discussed results from what she said is the largest randomized, controlled study to date examining a yoga program designed specifically for cancer survivors.

The researchers used the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP) Research Base to conduct a phase II/III clinical trial at nine CCOP centers, examining the efficacy of yoga for improving sleep quality, fatigue, and quality of life among 410 cancer survivors who reported problems sleeping after completing adjuvant therapy for their cancer.

To be eligible, patients were required to have a sleep disturbance level of 3 or greater on a scale ranging from 0-10, Dr. Mustian said. Those who had attended a yoga class within the last 3 months were excluded, as were those with sleep apnea and those with distant metastatic disease.

Patients were randomized to standard follow-up care or to standard follow-up care plus enrollment in Yoga for Cancer Survivors, (YOCAS), which encompasses components of hatha yoga and restorative yoga, including postures, breathing exercises, and mindfulness (including meditation exercises and visualization). The 75-minute classes met twice a week for 4 weeks.

At baseline and at the end of 4 weeks the researchers used the Pittsburgh Sleep Quality Index (PSQI) to measure sleep, the Multidimensional Fatigue Symptom Inventory to measure fatigue, and the Functional Assessment of Chronic Illness Therapy measurement system to assess quality of life. The mean age of participants was 56, most (96%) were female, and 75% were breast cancer patients.

Dr. Mustian reported that at the end of 4 weeks patients in the yoga group improved their overall sleep quality by 22%, while patients in the control group improved their overall sleep quality by 12%, a difference that was statistically significant.

At baseline, 84% of patients in the yoga group and 83% of patients in the control group had clinically impaired sleep quality defined as a PSQI score of 5 or higher. At the end of the 4-week study, 31% of patients in the yoga group recovered and no longer had clinically impaired sleep quality, while only 16% of patients in the control group recovered.

Dr. Mustian also reported that, compared with their counterparts in the control group, patients in the yoga group had significantly greater reductions in fatigue (42% vs. 12%, respectively), daytime sleepiness (29% vs. 5%), and quality of life (6% vs. 0%). In addition, use of sleep medication decreased by 21% in the yoga group but increased by 5% in the control group.

The trial was funded by grants from the National Cancer Institute.

The Yoga for Cancer Survivors program encompasses components of hatha yoga and restorative yoga, including postures and mindfulness.

Source ©Noam Armonn/iStockphoto.com

Major Finding: Alaska, the state with the lowest population density (1.2 people/square mile), has the highest suicide rate (23.1 deaths/100,000 population. Conversely, the District of Columbia, which has the highest population density (9,316 people/square mile), has the lowest suicide rate (5.3 deaths/100,000 population).

Data Source: National Center for Health Statistics and Bureau of Census Data from 2004.

Disclosures: Dr. D'Mello disclosed that he is a member of the speakers' bureau for Pfizer, AstraZeneca, and Schering.

NEW ORLEANS — Suicides in the United States tend to occur more often in rural compared with urban locations, but findings from a new study suggest that the relative scarcity of mental health care providers in rural areas may factor in to the association.

“More than 600 counties in the United States don't have any health care provider, and 1,600 counties don't have a mental health care provider,” Dr. Dale D'Mello of the department of psychiatry at Michigan State University, Lansing, said during a press briefing held at the annual meeting of the American Psychiatric Association. “One recent study found that the distribution of health care providers is imbalanced in rural compared with urban areas. We also know that the prevalence of conditions like depression is equal in urban and rural areas.”

To examine the association between population density, the availability of mental health providers, and suicide rates in each state, Dr. D'Mello and his associates evaluated National Center for Health Statistics and Bureau of Census Data information from the year 2004. Suicide rates were defined as deaths per 100,000 population. They correlated these data with the population density (persons per square mile) and the number of mental health providers per 100,000 population.

Dr. D'Mello reported that a significant powerful negative correlation was observed between the rate of suicide and population density. For example, Alaska, the state with the lowest population density (1.2 people/sq mile), also has the highest suicide rate (23.1 deaths/100,000 population). On the other hand, the District of Columbia, which has the highest population density (9,316 people/sq mile), has the lowest suicide rate (5.3/100,000 population).

“The other states start off between these two extremes,” Dr. D'Mello said. “I work in Lansing, Michigan, but I do telepsychiatry in a county 200 miles away that's rural. I'm interested in this area, because the suicide rate in [that] population is twice that of people I see face-to-face in Lansing.”

Similar and striking significant negative correlations were observed between the distribution of psychiatrists, psychologists, and social workers and suicide rates.

Certain economic and cultural factors also may contribute to the higher rate of suicides in rural population, he said. “Economic causes include the recent change in the rural economy from agriculture to manufacturing, resulting in a disproportionate burden of rural poverty in most countries around the globe,” he said.

As for cultural factors, Dr. D'Mello continued, “there are a large number of books and papers written about the rural culture as being different from urban culture, focusing on the male farmer—the importance based on self-reliance and independence in forming the identity of the male farmer, and the fact that health is correlated with productivity. When productivity declines, a crisis occurs.”

One possible solution to improving mental health care for people in rural settings, he concluded, is to deliver mental health care in primary settings, “integrating the delivery of mental health and medical health. This has occurred in many cases around the country.”

Major Finding: Alaska, the state with the lowest population density (1.2 people/square mile), has the highest suicide rate (23.1 deaths/100,000 population. Conversely, the District of Columbia, which has the highest population density (9,316 people/square mile), has the lowest suicide rate (5.3 deaths/100,000 population).

Data Source: National Center for Health Statistics and Bureau of Census Data from 2004.

Disclosures: Dr. D'Mello disclosed that he is a member of the speakers' bureau for Pfizer, AstraZeneca, and Schering.

NEW ORLEANS — Suicides in the United States tend to occur more often in rural compared with urban locations, but findings from a new study suggest that the relative scarcity of mental health care providers in rural areas may factor in to the association.

“More than 600 counties in the United States don't have any health care provider, and 1,600 counties don't have a mental health care provider,” Dr. Dale D'Mello of the department of psychiatry at Michigan State University, Lansing, said during a press briefing held at the annual meeting of the American Psychiatric Association. “One recent study found that the distribution of health care providers is imbalanced in rural compared with urban areas. We also know that the prevalence of conditions like depression is equal in urban and rural areas.”

To examine the association between population density, the availability of mental health providers, and suicide rates in each state, Dr. D'Mello and his associates evaluated National Center for Health Statistics and Bureau of Census Data information from the year 2004. Suicide rates were defined as deaths per 100,000 population. They correlated these data with the population density (persons per square mile) and the number of mental health providers per 100,000 population.

Dr. D'Mello reported that a significant powerful negative correlation was observed between the rate of suicide and population density. For example, Alaska, the state with the lowest population density (1.2 people/sq mile), also has the highest suicide rate (23.1 deaths/100,000 population). On the other hand, the District of Columbia, which has the highest population density (9,316 people/sq mile), has the lowest suicide rate (5.3/100,000 population).

“The other states start off between these two extremes,” Dr. D'Mello said. “I work in Lansing, Michigan, but I do telepsychiatry in a county 200 miles away that's rural. I'm interested in this area, because the suicide rate in [that] population is twice that of people I see face-to-face in Lansing.”

Similar and striking significant negative correlations were observed between the distribution of psychiatrists, psychologists, and social workers and suicide rates.

Certain economic and cultural factors also may contribute to the higher rate of suicides in rural population, he said. “Economic causes include the recent change in the rural economy from agriculture to manufacturing, resulting in a disproportionate burden of rural poverty in most countries around the globe,” he said.

As for cultural factors, Dr. D'Mello continued, “there are a large number of books and papers written about the rural culture as being different from urban culture, focusing on the male farmer—the importance based on self-reliance and independence in forming the identity of the male farmer, and the fact that health is correlated with productivity. When productivity declines, a crisis occurs.”

One possible solution to improving mental health care for people in rural settings, he concluded, is to deliver mental health care in primary settings, “integrating the delivery of mental health and medical health. This has occurred in many cases around the country.”

Major Finding: Alaska, the state with the lowest population density (1.2 people/square mile), has the highest suicide rate (23.1 deaths/100,000 population. Conversely, the District of Columbia, which has the highest population density (9,316 people/square mile), has the lowest suicide rate (5.3 deaths/100,000 population).

Data Source: National Center for Health Statistics and Bureau of Census Data from 2004.

Disclosures: Dr. D'Mello disclosed that he is a member of the speakers' bureau for Pfizer, AstraZeneca, and Schering.

NEW ORLEANS — Suicides in the United States tend to occur more often in rural compared with urban locations, but findings from a new study suggest that the relative scarcity of mental health care providers in rural areas may factor in to the association.

“More than 600 counties in the United States don't have any health care provider, and 1,600 counties don't have a mental health care provider,” Dr. Dale D'Mello of the department of psychiatry at Michigan State University, Lansing, said during a press briefing held at the annual meeting of the American Psychiatric Association. “One recent study found that the distribution of health care providers is imbalanced in rural compared with urban areas. We also know that the prevalence of conditions like depression is equal in urban and rural areas.”

To examine the association between population density, the availability of mental health providers, and suicide rates in each state, Dr. D'Mello and his associates evaluated National Center for Health Statistics and Bureau of Census Data information from the year 2004. Suicide rates were defined as deaths per 100,000 population. They correlated these data with the population density (persons per square mile) and the number of mental health providers per 100,000 population.

Dr. D'Mello reported that a significant powerful negative correlation was observed between the rate of suicide and population density. For example, Alaska, the state with the lowest population density (1.2 people/sq mile), also has the highest suicide rate (23.1 deaths/100,000 population). On the other hand, the District of Columbia, which has the highest population density (9,316 people/sq mile), has the lowest suicide rate (5.3/100,000 population).

“The other states start off between these two extremes,” Dr. D'Mello said. “I work in Lansing, Michigan, but I do telepsychiatry in a county 200 miles away that's rural. I'm interested in this area, because the suicide rate in [that] population is twice that of people I see face-to-face in Lansing.”

Similar and striking significant negative correlations were observed between the distribution of psychiatrists, psychologists, and social workers and suicide rates.

Certain economic and cultural factors also may contribute to the higher rate of suicides in rural population, he said. “Economic causes include the recent change in the rural economy from agriculture to manufacturing, resulting in a disproportionate burden of rural poverty in most countries around the globe,” he said.

As for cultural factors, Dr. D'Mello continued, “there are a large number of books and papers written about the rural culture as being different from urban culture, focusing on the male farmer—the importance based on self-reliance and independence in forming the identity of the male farmer, and the fact that health is correlated with productivity. When productivity declines, a crisis occurs.”

One possible solution to improving mental health care for people in rural settings, he concluded, is to deliver mental health care in primary settings, “integrating the delivery of mental health and medical health. This has occurred in many cases around the country.”

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines were developed “to avoid complications, contradictions, and confusion,” wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version “recognizes the new and increased influence” of the NIH Guidelines on Human Stem Cell Research released in 2009, and “incorporates references to the NIH guidelines as appropriate.”

Where there is complete overlap, the report continues, “the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines.”

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. “Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines,” the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, “only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding,” the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' guidelines were issued, the ethics committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State–funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

“Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes,” the report notes. “Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines” and recognizes “that states and other entities may choose to set their own policies, as New York has done.”

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. “Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies.”

The committee, which chose to disband after completion of the current guidelines, called for an “ongoing neutral forum” in which stem cell issues can be discussed. “Perhaps most needed is a forum that could bring together key stakeholders—including federal, state, academic, patient, and industry organizations and institutions—for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities,” they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known as the National Academies.

Disclosures: Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

A pdf of the report can be downloaded at www.nap.edu/catalog/12923.html

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines were developed “to avoid complications, contradictions, and confusion,” wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version “recognizes the new and increased influence” of the NIH Guidelines on Human Stem Cell Research released in 2009, and “incorporates references to the NIH guidelines as appropriate.”

Where there is complete overlap, the report continues, “the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines.”

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. “Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines,” the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, “only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding,” the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' guidelines were issued, the ethics committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State–funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

“Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes,” the report notes. “Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines” and recognizes “that states and other entities may choose to set their own policies, as New York has done.”

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. “Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies.”

The committee, which chose to disband after completion of the current guidelines, called for an “ongoing neutral forum” in which stem cell issues can be discussed. “Perhaps most needed is a forum that could bring together key stakeholders—including federal, state, academic, patient, and industry organizations and institutions—for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities,” they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known as the National Academies.

Disclosures: Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

A pdf of the report can be downloaded at www.nap.edu/catalog/12923.html

An amended version of the National Academies' Guidelines for Human Embryonic Stem Cell Research takes into account the expanding role of the National Institutes of Health in overseeing the field.

Originally published in 2005, the amended guidelines were developed “to avoid complications, contradictions, and confusion,” wrote the members of the National Academies' Human Embryonic Stem Cell Research Advisory Committee, led by R. Alta Charo, J.D., of the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., of the Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, Mass.

The updated version “recognizes the new and increased influence” of the NIH Guidelines on Human Stem Cell Research released in 2009, and “incorporates references to the NIH guidelines as appropriate.”

Where there is complete overlap, the report continues, “the advisory committee recommends that the NIH guidelines supersede its own. Where there are gaps or limitations in the NIH guidelines, the advisory committee recommends continued adoption of its own guidelines.”

The committee identified three areas in which non-NIH guidelines will continue to guide human embryonic stem (hES) cell research in the future. The first includes cell lines derived using nonfederal funds. “Because the continuing effect of the 'Dickey-Wicker' amendment means that derivation of hES cell lines cannot be supported by federal funds, such derivations will need continuing oversight outside the NIH guidelines,” the report states.

The second area in which non-NIH guidelines will continue to guide the field includes hES cell lines derived from other sources, such as from embryos produced using in vitro fertilization for research purposes or by nuclear transfer. Currently, “only hES cell lines derived from excess IVF embryos initially produced for reproductive purposes are currently eligible for NIH funding,” the report states.

A third area that will require oversight outside of the NIH, according to the report, includes experiments that mix human and animal cells not currently addressed by NIH guidelines.

The report also acknowledged certain areas of tension between NIH, the National Academies, and other guidelines on human stem cell research. For example, it noted that since the 2008 amendments to the National Academies' guidelines were issued, the ethics committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State–funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk, and burden involved in donating.

“Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes,” the report notes. “Compensation may not be based upon number or quality of eggs, but should cover only time and burden. While this advisory committee acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines” and recognizes “that states and other entities may choose to set their own policies, as New York has done.”

The committee also pointed out that its guidelines for consent of all gamete donors is not reflected in the 2009 NIH guidelines. “Further, a number of states and research institutions have declined to adopt this rule, given the lack of clear legal need for such consent from anonymous donors. The advisory committee also notes that the Food and Drug Administration's recent tissue transplant rules require screening of gamete donors except in cases involving sexually intimate partners. This suggests that stem cell lines made with donor (i.e., screened) gametes may be marginally safer for tissue transplants and may be more useable for FDA-regulated trials and therapies.”

The committee, which chose to disband after completion of the current guidelines, called for an “ongoing neutral forum” in which stem cell issues can be discussed. “Perhaps most needed is a forum that could bring together key stakeholders—including federal, state, academic, patient, and industry organizations and institutions—for periodic meetings that would address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities,” they wrote.

The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit organizations. They provide policy advice under a congressional charter granted to the National Academy of Sciences. Together, the four organizations are also known as the National Academies.

Disclosures: Funding for the report was supported by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute.

A pdf of the report can be downloaded at www.nap.edu/catalog/12923.html