Jeff Evans

WASHINGTON — A new, coordinated national response is needed to screen and treat hepatitis B and C viral infections because too many infected patients are unaware of their disease and go untreated, speakers said at a national forum on chronic viral hepatitis.

Acute hepatitis B virus (HBV) infections peaked in 1985 at about 12/100,000 people, whereas acute hepatitis C virus (HCV) infections topped out at about 2.5/100,000 in 1992. The burden of disease now remains primarily in people with chronic infections. Current estimates suggest that 2 million people are infected with HBV and 4 million are infected with HCV, totaling 2% of the U.S. population, according to Dr. W. Ray Kim.

“One can argue that of this 6 million, we know only of the tip of the iceberg that has been diagnosed,” said Dr. Kim of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn.

Despite the effectiveness of vaccines for HBV to lower the incidence of acute hepatitis B, immigrants from endemic countries who are unaware of their chronic infection continue to bring it into the United States.

To illustrate this point, Dr. Kim presented data contrasting the population of patients with chronic HBV infection at the Mayo Clinic with the general population of Olmsted County, where the institution is located. Most of the cases of chronic HBV infection occurred in minorities, many of whom were foreign born. Asian patients composed 53% of the chronic HBV patients and 99% of them were foreign born. Similarly, 29% of patients with chronic HBV were black and 91% of them were foreign born. In comparison, 13% of Mayo's patients with chronic HBV were white, but only 16% were foreign born. Olmsted County as a whole is 95% white.

Although the prevalence of HCV infection is declining because the incidence of the infection has been decreasing since the 1990s, chronically infected patients are becoming older and are experiencing more long-term complications associated with the virus, such as chronic liver disease and hepatocellular carcinoma, he said.

“All of those consequences of hepatitis B and hepatitis C infection have culminated in an epidemiologic trend” that may be a substantial contributor to the increasing incidence of hepatocellular carcinoma (HCC), in the United States, Dr. Kim said. “This is one of the few cancers whose incidence is increasing.”

Most HCC cases still occur in whites, but the rate is highest in foreign-born individuals, especially Asians and Hispanics, he said.

Many variables work together to reduce the clinical effectiveness of therapies for viral hepatitis, compared with the efficacy that they showed in clinical trials, observed Dr. Hashem El-Serag, professor of medicine at Baylor College of Medicine and GI section chief at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston.

In one survey of 128 VA facilities, an average of about 20% of patients at each center received treatment for hepatitis C. However, treatment rates at individual centers ranged from nearly 0% to 40%.

This variation may be partly the result of legitimate underuse of treatment when it is not clinically appropriate for some patients or when patients prefer not to undergo treatment. But the rest of the difference between the expected and observed use of treatment may be the result of disparities in access to health care, legal and regulatory issues, and discrimination and bias, he said.

In another study of 4,084 veterans who presented for treatment at 24 VA medical centers, researchers found that only 32% met standard criteria for eligibility for antiviral treatment and 40% were deemed treatment candidates by a clinician (Am. J. Gastroenterol. 2005;100:1772-9).

If clinicians are to translate the efficacy seen in clinical trials into real-world effectiveness, they must figure out if the remaining 60% or more of patients have reversible or treatable contraindications, which include ongoing substance use, comorbid medical disease, psychiatric disease, and advanced liver disease, Dr. El-Serag said.

In the VA study, 76% of patients who met standard criteria for treatment agreed to be treated. “The reasons for nonacceptance may also be modifiable,” depending on the way treatment options are presented to them. “Some of them want to defer diagnosis until better therapies arrive; others are concerned about side effects,” he said.

This VA study is a “very nice example” of how the efficacy of antiviral therapy can drop “tremendously” when put in terms of real-world clinical effectiveness, Dr. El-Serag said.

HBV presents “virtually similar issues [as HCV] but with less data in the United States,” he said.

Resources must be allocated to screen more patients with viral hepatitis, particularly hepatitis C, for HCC, as it becomes “increasingly more of a liver disease, rather than an infectious disease,” he said.

Screening patients with cirrhosis for HCC to detect cancer at an earlier stage has been shown to be efficacious in one randomized, controlled trial and in several observational cohort studies. But, even in studies of insured patients with HCC, few patients are appropriately screened.

For example, in a yet-to-be-published study of 3,903 Medicare patients with HCC, 57% had received at least one screening test for the cancer in the 3 years prior to their diagnosis. But only 7% were screened according to standard-of-care guidelines.

In the same study, physicians were nearly three times more likely to screen for HCC if they were affiliated with a medical school than if they had a solo or group practice. Gastroenterologists were three to four times more likely to screen than were primary care physicians alone, which illustrates that viral hepatitis is “becoming more and more not a primary care disease as it progresses,” he said.

The conference was endorsed by the American Association for the Study of Liver Diseases and was cosponsored by the American Gastroenterological Association Institute, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute of Allergy and Infectious Diseases.

Dr. Kim reported serving as a consultant to Bristol-Meyers Squibb Co., Gilead Sciences Inc., and Roche Pharmaceuticals. He disclosed receiving grant and research support from Romark Laboratories LC. Dr. El-Serag had nothing to disclose.

WASHINGTON — A new, coordinated national response is needed to screen and treat hepatitis B and C viral infections because too many infected patients are unaware of their disease and go untreated, speakers said at a national forum on chronic viral hepatitis.

Acute hepatitis B virus (HBV) infections peaked in 1985 at about 12/100,000 people, whereas acute hepatitis C virus (HCV) infections topped out at about 2.5/100,000 in 1992. The burden of disease now remains primarily in people with chronic infections. Current estimates suggest that 2 million people are infected with HBV and 4 million are infected with HCV, totaling 2% of the U.S. population, according to Dr. W. Ray Kim.

“One can argue that of this 6 million, we know only of the tip of the iceberg that has been diagnosed,” said Dr. Kim of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn.

Despite the effectiveness of vaccines for HBV to lower the incidence of acute hepatitis B, immigrants from endemic countries who are unaware of their chronic infection continue to bring it into the United States.

To illustrate this point, Dr. Kim presented data contrasting the population of patients with chronic HBV infection at the Mayo Clinic with the general population of Olmsted County, where the institution is located. Most of the cases of chronic HBV infection occurred in minorities, many of whom were foreign born. Asian patients composed 53% of the chronic HBV patients and 99% of them were foreign born. Similarly, 29% of patients with chronic HBV were black and 91% of them were foreign born. In comparison, 13% of Mayo's patients with chronic HBV were white, but only 16% were foreign born. Olmsted County as a whole is 95% white.

Although the prevalence of HCV infection is declining because the incidence of the infection has been decreasing since the 1990s, chronically infected patients are becoming older and are experiencing more long-term complications associated with the virus, such as chronic liver disease and hepatocellular carcinoma, he said.

“All of those consequences of hepatitis B and hepatitis C infection have culminated in an epidemiologic trend” that may be a substantial contributor to the increasing incidence of hepatocellular carcinoma (HCC), in the United States, Dr. Kim said. “This is one of the few cancers whose incidence is increasing.”

Most HCC cases still occur in whites, but the rate is highest in foreign-born individuals, especially Asians and Hispanics, he said.

Many variables work together to reduce the clinical effectiveness of therapies for viral hepatitis, compared with the efficacy that they showed in clinical trials, observed Dr. Hashem El-Serag, professor of medicine at Baylor College of Medicine and GI section chief at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston.

In one survey of 128 VA facilities, an average of about 20% of patients at each center received treatment for hepatitis C. However, treatment rates at individual centers ranged from nearly 0% to 40%.

This variation may be partly the result of legitimate underuse of treatment when it is not clinically appropriate for some patients or when patients prefer not to undergo treatment. But the rest of the difference between the expected and observed use of treatment may be the result of disparities in access to health care, legal and regulatory issues, and discrimination and bias, he said.

In another study of 4,084 veterans who presented for treatment at 24 VA medical centers, researchers found that only 32% met standard criteria for eligibility for antiviral treatment and 40% were deemed treatment candidates by a clinician (Am. J. Gastroenterol. 2005;100:1772-9).

If clinicians are to translate the efficacy seen in clinical trials into real-world effectiveness, they must figure out if the remaining 60% or more of patients have reversible or treatable contraindications, which include ongoing substance use, comorbid medical disease, psychiatric disease, and advanced liver disease, Dr. El-Serag said.

In the VA study, 76% of patients who met standard criteria for treatment agreed to be treated. “The reasons for nonacceptance may also be modifiable,” depending on the way treatment options are presented to them. “Some of them want to defer diagnosis until better therapies arrive; others are concerned about side effects,” he said.

This VA study is a “very nice example” of how the efficacy of antiviral therapy can drop “tremendously” when put in terms of real-world clinical effectiveness, Dr. El-Serag said.

HBV presents “virtually similar issues [as HCV] but with less data in the United States,” he said.

Resources must be allocated to screen more patients with viral hepatitis, particularly hepatitis C, for HCC, as it becomes “increasingly more of a liver disease, rather than an infectious disease,” he said.

Screening patients with cirrhosis for HCC to detect cancer at an earlier stage has been shown to be efficacious in one randomized, controlled trial and in several observational cohort studies. But, even in studies of insured patients with HCC, few patients are appropriately screened.

For example, in a yet-to-be-published study of 3,903 Medicare patients with HCC, 57% had received at least one screening test for the cancer in the 3 years prior to their diagnosis. But only 7% were screened according to standard-of-care guidelines.

In the same study, physicians were nearly three times more likely to screen for HCC if they were affiliated with a medical school than if they had a solo or group practice. Gastroenterologists were three to four times more likely to screen than were primary care physicians alone, which illustrates that viral hepatitis is “becoming more and more not a primary care disease as it progresses,” he said.

The conference was endorsed by the American Association for the Study of Liver Diseases and was cosponsored by the American Gastroenterological Association Institute, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute of Allergy and Infectious Diseases.

Dr. Kim reported serving as a consultant to Bristol-Meyers Squibb Co., Gilead Sciences Inc., and Roche Pharmaceuticals. He disclosed receiving grant and research support from Romark Laboratories LC. Dr. El-Serag had nothing to disclose.

WASHINGTON — A new, coordinated national response is needed to screen and treat hepatitis B and C viral infections because too many infected patients are unaware of their disease and go untreated, speakers said at a national forum on chronic viral hepatitis.

Acute hepatitis B virus (HBV) infections peaked in 1985 at about 12/100,000 people, whereas acute hepatitis C virus (HCV) infections topped out at about 2.5/100,000 in 1992. The burden of disease now remains primarily in people with chronic infections. Current estimates suggest that 2 million people are infected with HBV and 4 million are infected with HCV, totaling 2% of the U.S. population, according to Dr. W. Ray Kim.

“One can argue that of this 6 million, we know only of the tip of the iceberg that has been diagnosed,” said Dr. Kim of the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn.

Despite the effectiveness of vaccines for HBV to lower the incidence of acute hepatitis B, immigrants from endemic countries who are unaware of their chronic infection continue to bring it into the United States.

To illustrate this point, Dr. Kim presented data contrasting the population of patients with chronic HBV infection at the Mayo Clinic with the general population of Olmsted County, where the institution is located. Most of the cases of chronic HBV infection occurred in minorities, many of whom were foreign born. Asian patients composed 53% of the chronic HBV patients and 99% of them were foreign born. Similarly, 29% of patients with chronic HBV were black and 91% of them were foreign born. In comparison, 13% of Mayo's patients with chronic HBV were white, but only 16% were foreign born. Olmsted County as a whole is 95% white.

Although the prevalence of HCV infection is declining because the incidence of the infection has been decreasing since the 1990s, chronically infected patients are becoming older and are experiencing more long-term complications associated with the virus, such as chronic liver disease and hepatocellular carcinoma, he said.

“All of those consequences of hepatitis B and hepatitis C infection have culminated in an epidemiologic trend” that may be a substantial contributor to the increasing incidence of hepatocellular carcinoma (HCC), in the United States, Dr. Kim said. “This is one of the few cancers whose incidence is increasing.”

Most HCC cases still occur in whites, but the rate is highest in foreign-born individuals, especially Asians and Hispanics, he said.

Many variables work together to reduce the clinical effectiveness of therapies for viral hepatitis, compared with the efficacy that they showed in clinical trials, observed Dr. Hashem El-Serag, professor of medicine at Baylor College of Medicine and GI section chief at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston.

In one survey of 128 VA facilities, an average of about 20% of patients at each center received treatment for hepatitis C. However, treatment rates at individual centers ranged from nearly 0% to 40%.

This variation may be partly the result of legitimate underuse of treatment when it is not clinically appropriate for some patients or when patients prefer not to undergo treatment. But the rest of the difference between the expected and observed use of treatment may be the result of disparities in access to health care, legal and regulatory issues, and discrimination and bias, he said.

In another study of 4,084 veterans who presented for treatment at 24 VA medical centers, researchers found that only 32% met standard criteria for eligibility for antiviral treatment and 40% were deemed treatment candidates by a clinician (Am. J. Gastroenterol. 2005;100:1772-9).

If clinicians are to translate the efficacy seen in clinical trials into real-world effectiveness, they must figure out if the remaining 60% or more of patients have reversible or treatable contraindications, which include ongoing substance use, comorbid medical disease, psychiatric disease, and advanced liver disease, Dr. El-Serag said.

In the VA study, 76% of patients who met standard criteria for treatment agreed to be treated. “The reasons for nonacceptance may also be modifiable,” depending on the way treatment options are presented to them. “Some of them want to defer diagnosis until better therapies arrive; others are concerned about side effects,” he said.

This VA study is a “very nice example” of how the efficacy of antiviral therapy can drop “tremendously” when put in terms of real-world clinical effectiveness, Dr. El-Serag said.

HBV presents “virtually similar issues [as HCV] but with less data in the United States,” he said.

Resources must be allocated to screen more patients with viral hepatitis, particularly hepatitis C, for HCC, as it becomes “increasingly more of a liver disease, rather than an infectious disease,” he said.

Screening patients with cirrhosis for HCC to detect cancer at an earlier stage has been shown to be efficacious in one randomized, controlled trial and in several observational cohort studies. But, even in studies of insured patients with HCC, few patients are appropriately screened.

For example, in a yet-to-be-published study of 3,903 Medicare patients with HCC, 57% had received at least one screening test for the cancer in the 3 years prior to their diagnosis. But only 7% were screened according to standard-of-care guidelines.

In the same study, physicians were nearly three times more likely to screen for HCC if they were affiliated with a medical school than if they had a solo or group practice. Gastroenterologists were three to four times more likely to screen than were primary care physicians alone, which illustrates that viral hepatitis is “becoming more and more not a primary care disease as it progresses,” he said.

The conference was endorsed by the American Association for the Study of Liver Diseases and was cosponsored by the American Gastroenterological Association Institute, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, and the National Institute of Allergy and Infectious Diseases.

Dr. Kim reported serving as a consultant to Bristol-Meyers Squibb Co., Gilead Sciences Inc., and Roche Pharmaceuticals. He disclosed receiving grant and research support from Romark Laboratories LC. Dr. El-Serag had nothing to disclose.

Repair of incidental patent foramen ovale that is diagnosed during cardiothoracic surgery may be associated with an increased risk of postoperative stroke, according to findings from a large retrospective study.

Although Dr. Richard A. Krasuski and his associates at the Cleveland Clinic found no concurrent increase in perioperative complications or death after patent foramen ovale repair, they argued that their finding of a potentially increased risk of stroke “should discourage routine surgical closure and foster further investigation to delineate whether there is any benefit in terms of long-term stroke prevention and which patients might benefit from this intervention.”

Patent foramen ovales (PFOs) have become a common incidental finding with the widespread use of intraoperative transesophageal echocardiography (TEE) during cardiothoracic surgery, although cardiothoracic surgeons manage the discoveries with a high degree of variability, according to Dr. Krasuski and his colleagues.

In one survey, 28% of surgeons said that they always closed intraoperatively diagnosed PFO while performing planned operations with cardiopulmonary bypass pump support and 10% said they never did.

In addition, 11% of the respondents reported that they always converted a planned off-pump procedure to on-pump to close the PFO (J. Cardiothorac. Vasc. Anesth. 2005;19:150–4).

In the current study, Dr. Krasuski and his colleagues identified 13,092 patients who had undergone cardiothoracic surgery with intraoperative TEE at the Cleveland Clinic during 1995–2006. They excluded patients who had been previously diagnosed with a PFO or an atrial septal defect (JAMA 2009;302:290–7).

The investigators found that 2,277 (17%) patients with an intraoperatively discovered PFO were diagnosed with the defect at a nearly constant rate during the study period, although the rate of repair steadily increased to a peak of almost 40% in 2003.

Compared with 1,638 patients who did not undergo PFO repair, the 639 patients who underwent PFO repair during the study period were significantly more likely to be women (33% vs. 42% in the repaired group); younger (64 years vs. 61 years); and undergoing mitral or tricuspid valve surgery (32% vs. 51%); and to have a history of transient ischemic attack or stroke (10% vs. 16%); a dilated left atrium (51% vs. 61%); and atrial fibrillation (10% vs. 13%).

Patients with a repaired PFO also had significantly fewer comorbidities than did those with an unrepaired PFO. These included hypertension, previous myocardial infarction, smoking, peripheral vascular disease, and carotid artery disease.

There were no important differences in perioperative outcomes between patients with an incidentally discovered PFO and those with no PFO.

However, patients who underwent PFO repair were 2.5 times more likely to have an in-hospital stroke than were patients with an unrepaired PFO after the researchers controlled for differences between the groups. In-hospital strokes occurred in 2.8% of patients with a repaired PFO and in 1.2% of those with an unrepaired PFO.

The researchers did not find any differences in comparisons of long-term mortality between patients with and without a PFO, or between patients with a repaired or an unrepaired PFO. Survivors in the study had a mean follow-up of 5.6 years.

“One might argue that no long-term difference was detected because surgeons were able to properly select patients undergoing repair, but this seems improbable given our extensive propensity-matched analysis.

“In contrast, we feel these data suggest that asymptomatic PFO in our population was likely a benign entity and repair might have increased the risk of postoperative stroke,” the investigators wrote.

The researchers were unaware of what medications the patients were taking before and after surgery, such as anticoagulation or antiplatelet therapy.

Dr. Krasuski reported having served as a consultant to Gore Medical and on the speakers bureau of AGA Medical.

The finding of a potentially increased risk of stroke 'should discourage routine surgical [PFO] closure.'

Source Dr. Krasuski

Repair of incidental patent foramen ovale that is diagnosed during cardiothoracic surgery may be associated with an increased risk of postoperative stroke, according to findings from a large retrospective study.

Although Dr. Richard A. Krasuski and his associates at the Cleveland Clinic found no concurrent increase in perioperative complications or death after patent foramen ovale repair, they argued that their finding of a potentially increased risk of stroke “should discourage routine surgical closure and foster further investigation to delineate whether there is any benefit in terms of long-term stroke prevention and which patients might benefit from this intervention.”

Patent foramen ovales (PFOs) have become a common incidental finding with the widespread use of intraoperative transesophageal echocardiography (TEE) during cardiothoracic surgery, although cardiothoracic surgeons manage the discoveries with a high degree of variability, according to Dr. Krasuski and his colleagues.

In one survey, 28% of surgeons said that they always closed intraoperatively diagnosed PFO while performing planned operations with cardiopulmonary bypass pump support and 10% said they never did.

In addition, 11% of the respondents reported that they always converted a planned off-pump procedure to on-pump to close the PFO (J. Cardiothorac. Vasc. Anesth. 2005;19:150–4).

In the current study, Dr. Krasuski and his colleagues identified 13,092 patients who had undergone cardiothoracic surgery with intraoperative TEE at the Cleveland Clinic during 1995–2006. They excluded patients who had been previously diagnosed with a PFO or an atrial septal defect (JAMA 2009;302:290–7).

The investigators found that 2,277 (17%) patients with an intraoperatively discovered PFO were diagnosed with the defect at a nearly constant rate during the study period, although the rate of repair steadily increased to a peak of almost 40% in 2003.

Compared with 1,638 patients who did not undergo PFO repair, the 639 patients who underwent PFO repair during the study period were significantly more likely to be women (33% vs. 42% in the repaired group); younger (64 years vs. 61 years); and undergoing mitral or tricuspid valve surgery (32% vs. 51%); and to have a history of transient ischemic attack or stroke (10% vs. 16%); a dilated left atrium (51% vs. 61%); and atrial fibrillation (10% vs. 13%).

Patients with a repaired PFO also had significantly fewer comorbidities than did those with an unrepaired PFO. These included hypertension, previous myocardial infarction, smoking, peripheral vascular disease, and carotid artery disease.

There were no important differences in perioperative outcomes between patients with an incidentally discovered PFO and those with no PFO.

However, patients who underwent PFO repair were 2.5 times more likely to have an in-hospital stroke than were patients with an unrepaired PFO after the researchers controlled for differences between the groups. In-hospital strokes occurred in 2.8% of patients with a repaired PFO and in 1.2% of those with an unrepaired PFO.

The researchers did not find any differences in comparisons of long-term mortality between patients with and without a PFO, or between patients with a repaired or an unrepaired PFO. Survivors in the study had a mean follow-up of 5.6 years.

“One might argue that no long-term difference was detected because surgeons were able to properly select patients undergoing repair, but this seems improbable given our extensive propensity-matched analysis.

“In contrast, we feel these data suggest that asymptomatic PFO in our population was likely a benign entity and repair might have increased the risk of postoperative stroke,” the investigators wrote.

The researchers were unaware of what medications the patients were taking before and after surgery, such as anticoagulation or antiplatelet therapy.

Dr. Krasuski reported having served as a consultant to Gore Medical and on the speakers bureau of AGA Medical.

The finding of a potentially increased risk of stroke 'should discourage routine surgical [PFO] closure.'

Source Dr. Krasuski

Repair of incidental patent foramen ovale that is diagnosed during cardiothoracic surgery may be associated with an increased risk of postoperative stroke, according to findings from a large retrospective study.

Although Dr. Richard A. Krasuski and his associates at the Cleveland Clinic found no concurrent increase in perioperative complications or death after patent foramen ovale repair, they argued that their finding of a potentially increased risk of stroke “should discourage routine surgical closure and foster further investigation to delineate whether there is any benefit in terms of long-term stroke prevention and which patients might benefit from this intervention.”

Patent foramen ovales (PFOs) have become a common incidental finding with the widespread use of intraoperative transesophageal echocardiography (TEE) during cardiothoracic surgery, although cardiothoracic surgeons manage the discoveries with a high degree of variability, according to Dr. Krasuski and his colleagues.

In one survey, 28% of surgeons said that they always closed intraoperatively diagnosed PFO while performing planned operations with cardiopulmonary bypass pump support and 10% said they never did.

In addition, 11% of the respondents reported that they always converted a planned off-pump procedure to on-pump to close the PFO (J. Cardiothorac. Vasc. Anesth. 2005;19:150–4).

In the current study, Dr. Krasuski and his colleagues identified 13,092 patients who had undergone cardiothoracic surgery with intraoperative TEE at the Cleveland Clinic during 1995–2006. They excluded patients who had been previously diagnosed with a PFO or an atrial septal defect (JAMA 2009;302:290–7).

The investigators found that 2,277 (17%) patients with an intraoperatively discovered PFO were diagnosed with the defect at a nearly constant rate during the study period, although the rate of repair steadily increased to a peak of almost 40% in 2003.

Compared with 1,638 patients who did not undergo PFO repair, the 639 patients who underwent PFO repair during the study period were significantly more likely to be women (33% vs. 42% in the repaired group); younger (64 years vs. 61 years); and undergoing mitral or tricuspid valve surgery (32% vs. 51%); and to have a history of transient ischemic attack or stroke (10% vs. 16%); a dilated left atrium (51% vs. 61%); and atrial fibrillation (10% vs. 13%).

Patients with a repaired PFO also had significantly fewer comorbidities than did those with an unrepaired PFO. These included hypertension, previous myocardial infarction, smoking, peripheral vascular disease, and carotid artery disease.

There were no important differences in perioperative outcomes between patients with an incidentally discovered PFO and those with no PFO.

However, patients who underwent PFO repair were 2.5 times more likely to have an in-hospital stroke than were patients with an unrepaired PFO after the researchers controlled for differences between the groups. In-hospital strokes occurred in 2.8% of patients with a repaired PFO and in 1.2% of those with an unrepaired PFO.

The researchers did not find any differences in comparisons of long-term mortality between patients with and without a PFO, or between patients with a repaired or an unrepaired PFO. Survivors in the study had a mean follow-up of 5.6 years.

“One might argue that no long-term difference was detected because surgeons were able to properly select patients undergoing repair, but this seems improbable given our extensive propensity-matched analysis.

“In contrast, we feel these data suggest that asymptomatic PFO in our population was likely a benign entity and repair might have increased the risk of postoperative stroke,” the investigators wrote.

The researchers were unaware of what medications the patients were taking before and after surgery, such as anticoagulation or antiplatelet therapy.

Dr. Krasuski reported having served as a consultant to Gore Medical and on the speakers bureau of AGA Medical.

The finding of a potentially increased risk of stroke 'should discourage routine surgical [PFO] closure.'

Source Dr. Krasuski

The infrequent but potentially lethal problem of hyponatremia in hospitalized children can be prevented with safety checks, reminders, and education throughout various hospital areas, according to patient safety experts.

Two recent deaths of 6-year-old children who developed hyponatremia postoperatively illustrate how the lack of systems for preventing related errors and a lack of recognition of the condition continue to be a problem in hospitals.

Children who are recovering from surgery, taking certain medications, or fighting an acute illness such as meningitis that requires intravenous fluids may have increased production of antidiuretic hormone (also called vasopressin), resulting in increased water retention. “It certainly speaks to all of the pediatric community that we be very careful with hypotonic intravenous fluids, especially D5W [dextrose 5% in water] and D5 quarter-normal saline,” said Dr. Paul Hain, a pediatric hospitalist and associate chief of staff at the Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tenn.

“Not only do we need systems redesign to help make it difficult to use these fluids inappropriately, but we also need physician education to make sure that folks understand the dangers of using these fluids in instances where they are not appropriate,” Dr. Hain said in an interview.

In one of the two recently reported cases, a pharmacist incorrectly calculated an excessively high infusion rate of plain D5W to give to a girl after outpatient tonsillectomy and adenoidectomy. Hyponatremic signs and symptoms—vomiting, lethargy, jerking movements, rigid extremities, and rolled-back eyes—were mistaken for a dystonic reaction to an antiemetic that had been administered, according to a report in a newsletter of the Institute for Safe Medication Practices (ISMP Medication Safety Alert! 2009 Aug. 13;14[16]).

Clinicians continued to follow the incorrect electronic medication administration record after the child vomited dark, bloody secretions. The patient's symptoms continued to worsen after she was admitted to a medical-surgical unit. A pediatrician who was consulted to manage the patient's seizures diagnosed hyponatremia and water intoxication. A lab study revealed a critically low sodium concentration of 107 mEq/L (the normal range is 135-147 mEq/L). The child later died of cerebral edema.

“Many hospitals, including my own, have taken the D5W and keep it only in the pharmacy, so it can't be readily accessed and can only be obtained by a physician's order that has to go all the way to the pharmacy and be checked,” Dr. Hain said. Computerized order entry forms also could have been used to calculate the maintenance rate of saline infusion.

Dr. Shannon Phillips, the patient safety officer at the Cleveland Clinic, said that hypotonic intravenous fluids could be removed from the list of available options for pediatric patients in a computerized order entry system. Alternatively, the order entry system could be set up to alert the prescriber and ask about the decision, referencing why hypotonic fluids or certain medications might be inappropriate. For additional layers of redundancy, alerts also could be sent to the pharmacist and the nurse who administers the fluid or medication.

Even when computerized order entry is not available, it's possible to develop care pathways and protocols for situations such as postoperative surgical care, said Dr. Phillips, a pediatric hospitalist at Cleveland Clinic Children's Hospital.

Protocols of this kind are equally helpful in large tertiary care centers such as the Cleveland Clinic and in community hospitals that have a small number of pediatric beds and medical teams primarily involved in adult care, she said in an interview.

The second case involved a boy on postoperative day 1 after surgery for coarctation of the aorta. He was prescribed furosemide for less-than-expected urine output despite having received several doses of ethacrynic acid (Edecrin). The next day, the boy was prescribed an infusion of sodium chloride for a low serum sodium level, but it is unclear if the infusion ever occurred because it was not documented in the patient's medication administration record.

The boy became less and less responsive, and despite repeated concerns expressed by his parents, nurses thought he was “simply sleeping soundly.” New seizurelike activity—attributed by the nurses to the child to being fidgety from pain—and other symptoms of hyponatremia were not reported in a timely manner to the attending physician, who later recognized the problem during a routine assessment. By that point, it was too late to prevent the child's death.

These cases also point to the benefits of safety systems such as “rapid-response teams that anyone in the medical care team, including the parents, can activate,” and of having a group of hospitalists who are easily available for consultation, Dr. Hain said.

Studies that included children and adults have shown that within 1 week of surgery, more than 4% of all postoperative patients and 30% of patients treated in intensive care units develop clinically significant hyponatremia.

'We need systems redesign to help make it difficult to use these fluids inappropriately.'

Source DR. HAIN

The infrequent but potentially lethal problem of hyponatremia in hospitalized children can be prevented with safety checks, reminders, and education throughout various hospital areas, according to patient safety experts.

Two recent deaths of 6-year-old children who developed hyponatremia postoperatively illustrate how the lack of systems for preventing related errors and a lack of recognition of the condition continue to be a problem in hospitals.

Children who are recovering from surgery, taking certain medications, or fighting an acute illness such as meningitis that requires intravenous fluids may have increased production of antidiuretic hormone (also called vasopressin), resulting in increased water retention. “It certainly speaks to all of the pediatric community that we be very careful with hypotonic intravenous fluids, especially D5W [dextrose 5% in water] and D5 quarter-normal saline,” said Dr. Paul Hain, a pediatric hospitalist and associate chief of staff at the Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tenn.

“Not only do we need systems redesign to help make it difficult to use these fluids inappropriately, but we also need physician education to make sure that folks understand the dangers of using these fluids in instances where they are not appropriate,” Dr. Hain said in an interview.

In one of the two recently reported cases, a pharmacist incorrectly calculated an excessively high infusion rate of plain D5W to give to a girl after outpatient tonsillectomy and adenoidectomy. Hyponatremic signs and symptoms—vomiting, lethargy, jerking movements, rigid extremities, and rolled-back eyes—were mistaken for a dystonic reaction to an antiemetic that had been administered, according to a report in a newsletter of the Institute for Safe Medication Practices (ISMP Medication Safety Alert! 2009 Aug. 13;14[16]).

Clinicians continued to follow the incorrect electronic medication administration record after the child vomited dark, bloody secretions. The patient's symptoms continued to worsen after she was admitted to a medical-surgical unit. A pediatrician who was consulted to manage the patient's seizures diagnosed hyponatremia and water intoxication. A lab study revealed a critically low sodium concentration of 107 mEq/L (the normal range is 135-147 mEq/L). The child later died of cerebral edema.

“Many hospitals, including my own, have taken the D5W and keep it only in the pharmacy, so it can't be readily accessed and can only be obtained by a physician's order that has to go all the way to the pharmacy and be checked,” Dr. Hain said. Computerized order entry forms also could have been used to calculate the maintenance rate of saline infusion.

Dr. Shannon Phillips, the patient safety officer at the Cleveland Clinic, said that hypotonic intravenous fluids could be removed from the list of available options for pediatric patients in a computerized order entry system. Alternatively, the order entry system could be set up to alert the prescriber and ask about the decision, referencing why hypotonic fluids or certain medications might be inappropriate. For additional layers of redundancy, alerts also could be sent to the pharmacist and the nurse who administers the fluid or medication.

Even when computerized order entry is not available, it's possible to develop care pathways and protocols for situations such as postoperative surgical care, said Dr. Phillips, a pediatric hospitalist at Cleveland Clinic Children's Hospital.

Protocols of this kind are equally helpful in large tertiary care centers such as the Cleveland Clinic and in community hospitals that have a small number of pediatric beds and medical teams primarily involved in adult care, she said in an interview.

The second case involved a boy on postoperative day 1 after surgery for coarctation of the aorta. He was prescribed furosemide for less-than-expected urine output despite having received several doses of ethacrynic acid (Edecrin). The next day, the boy was prescribed an infusion of sodium chloride for a low serum sodium level, but it is unclear if the infusion ever occurred because it was not documented in the patient's medication administration record.

The boy became less and less responsive, and despite repeated concerns expressed by his parents, nurses thought he was “simply sleeping soundly.” New seizurelike activity—attributed by the nurses to the child to being fidgety from pain—and other symptoms of hyponatremia were not reported in a timely manner to the attending physician, who later recognized the problem during a routine assessment. By that point, it was too late to prevent the child's death.

These cases also point to the benefits of safety systems such as “rapid-response teams that anyone in the medical care team, including the parents, can activate,” and of having a group of hospitalists who are easily available for consultation, Dr. Hain said.

Studies that included children and adults have shown that within 1 week of surgery, more than 4% of all postoperative patients and 30% of patients treated in intensive care units develop clinically significant hyponatremia.

'We need systems redesign to help make it difficult to use these fluids inappropriately.'

Source DR. HAIN

The infrequent but potentially lethal problem of hyponatremia in hospitalized children can be prevented with safety checks, reminders, and education throughout various hospital areas, according to patient safety experts.

Two recent deaths of 6-year-old children who developed hyponatremia postoperatively illustrate how the lack of systems for preventing related errors and a lack of recognition of the condition continue to be a problem in hospitals.

Children who are recovering from surgery, taking certain medications, or fighting an acute illness such as meningitis that requires intravenous fluids may have increased production of antidiuretic hormone (also called vasopressin), resulting in increased water retention. “It certainly speaks to all of the pediatric community that we be very careful with hypotonic intravenous fluids, especially D5W [dextrose 5% in water] and D5 quarter-normal saline,” said Dr. Paul Hain, a pediatric hospitalist and associate chief of staff at the Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tenn.

“Not only do we need systems redesign to help make it difficult to use these fluids inappropriately, but we also need physician education to make sure that folks understand the dangers of using these fluids in instances where they are not appropriate,” Dr. Hain said in an interview.

In one of the two recently reported cases, a pharmacist incorrectly calculated an excessively high infusion rate of plain D5W to give to a girl after outpatient tonsillectomy and adenoidectomy. Hyponatremic signs and symptoms—vomiting, lethargy, jerking movements, rigid extremities, and rolled-back eyes—were mistaken for a dystonic reaction to an antiemetic that had been administered, according to a report in a newsletter of the Institute for Safe Medication Practices (ISMP Medication Safety Alert! 2009 Aug. 13;14[16]).

Clinicians continued to follow the incorrect electronic medication administration record after the child vomited dark, bloody secretions. The patient's symptoms continued to worsen after she was admitted to a medical-surgical unit. A pediatrician who was consulted to manage the patient's seizures diagnosed hyponatremia and water intoxication. A lab study revealed a critically low sodium concentration of 107 mEq/L (the normal range is 135-147 mEq/L). The child later died of cerebral edema.

“Many hospitals, including my own, have taken the D5W and keep it only in the pharmacy, so it can't be readily accessed and can only be obtained by a physician's order that has to go all the way to the pharmacy and be checked,” Dr. Hain said. Computerized order entry forms also could have been used to calculate the maintenance rate of saline infusion.

Dr. Shannon Phillips, the patient safety officer at the Cleveland Clinic, said that hypotonic intravenous fluids could be removed from the list of available options for pediatric patients in a computerized order entry system. Alternatively, the order entry system could be set up to alert the prescriber and ask about the decision, referencing why hypotonic fluids or certain medications might be inappropriate. For additional layers of redundancy, alerts also could be sent to the pharmacist and the nurse who administers the fluid or medication.

Even when computerized order entry is not available, it's possible to develop care pathways and protocols for situations such as postoperative surgical care, said Dr. Phillips, a pediatric hospitalist at Cleveland Clinic Children's Hospital.

Protocols of this kind are equally helpful in large tertiary care centers such as the Cleveland Clinic and in community hospitals that have a small number of pediatric beds and medical teams primarily involved in adult care, she said in an interview.

The second case involved a boy on postoperative day 1 after surgery for coarctation of the aorta. He was prescribed furosemide for less-than-expected urine output despite having received several doses of ethacrynic acid (Edecrin). The next day, the boy was prescribed an infusion of sodium chloride for a low serum sodium level, but it is unclear if the infusion ever occurred because it was not documented in the patient's medication administration record.

The boy became less and less responsive, and despite repeated concerns expressed by his parents, nurses thought he was “simply sleeping soundly.” New seizurelike activity—attributed by the nurses to the child to being fidgety from pain—and other symptoms of hyponatremia were not reported in a timely manner to the attending physician, who later recognized the problem during a routine assessment. By that point, it was too late to prevent the child's death.

These cases also point to the benefits of safety systems such as “rapid-response teams that anyone in the medical care team, including the parents, can activate,” and of having a group of hospitalists who are easily available for consultation, Dr. Hain said.

Studies that included children and adults have shown that within 1 week of surgery, more than 4% of all postoperative patients and 30% of patients treated in intensive care units develop clinically significant hyponatremia.

'We need systems redesign to help make it difficult to use these fluids inappropriately.'

Source DR. HAIN

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about risks identified by DTC genetic tests.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports that are derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

The investigators reported that their searches took 3-18 minutes to obtain a complete answer, which is longer than most physicians would be willing to spend, he said.

These results may reflect deficiencies in training in clinical genetics, he said. (See box.)

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said.

Source COURTESY UCLA

Genetics Rare in Medical Schools

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

“There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies, and that they are the province of primarily two different groups of providers—ob.gyns. and pediatricians,” he said.

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5).

The two schools with integrated genetics programs—the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program—both seek to teach how to evaluate human genetic variability in the context of the community and the environment.

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about risks identified by DTC genetic tests.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports that are derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

The investigators reported that their searches took 3-18 minutes to obtain a complete answer, which is longer than most physicians would be willing to spend, he said.

These results may reflect deficiencies in training in clinical genetics, he said. (See box.)

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said.

Source COURTESY UCLA

Genetics Rare in Medical Schools

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

“There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies, and that they are the province of primarily two different groups of providers—ob.gyns. and pediatricians,” he said.

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5).

The two schools with integrated genetics programs—the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program—both seek to teach how to evaluate human genetic variability in the context of the community and the environment.

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about risks identified by DTC genetic tests.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports that are derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

The investigators reported that their searches took 3-18 minutes to obtain a complete answer, which is longer than most physicians would be willing to spend, he said.

These results may reflect deficiencies in training in clinical genetics, he said. (See box.)

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“There's a lot of confusion between these services and medical care,” Dr. Patricia Ganz said.

Source COURTESY UCLA

Genetics Rare in Medical Schools

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

“There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies, and that they are the province of primarily two different groups of providers—ob.gyns. and pediatricians,” he said.

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5).

The two schools with integrated genetics programs—the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program—both seek to teach how to evaluate human genetic variability in the context of the community and the environment.

WASHINGTON – Few physicians feel prepared to interpret the findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

“There's a lot of confusion between these services and medical care,” said Dr. Patricia Ganz. DTC companies may say that test results are for educational and research purposes only and that they cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

In the same reports, national surveys of consumers in the same periods showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said that they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had at least one patient who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, said Joseph McInerney, who serves as director executive director of the National Coalition for Health Professional Education in Genetics.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

These results may reflect deficiencies in training in clinical genetics, he said.

Dr. Ganz noted that when physicians advise patients about their DTC test results, it is unclear if the addition of genetic information to family history actually promotes appropriate behavior change.

“We need scientific guidance on these tests that can be linked to effective screening strategies. I think doing them in isolation and not doing studies to see if it changes behavior or changes outcome is false advertising,” commented Dr. Ganz.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“We need scientific guidance on these [DTC] tests,” says Dr. Patricia Ganz.

Source Courtesy UCLA

WASHINGTON – Few physicians feel prepared to interpret the findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

“There's a lot of confusion between these services and medical care,” said Dr. Patricia Ganz. DTC companies may say that test results are for educational and research purposes only and that they cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

In the same reports, national surveys of consumers in the same periods showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said that they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had at least one patient who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, said Joseph McInerney, who serves as director executive director of the National Coalition for Health Professional Education in Genetics.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

These results may reflect deficiencies in training in clinical genetics, he said.

Dr. Ganz noted that when physicians advise patients about their DTC test results, it is unclear if the addition of genetic information to family history actually promotes appropriate behavior change.

“We need scientific guidance on these tests that can be linked to effective screening strategies. I think doing them in isolation and not doing studies to see if it changes behavior or changes outcome is false advertising,” commented Dr. Ganz.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“We need scientific guidance on these [DTC] tests,” says Dr. Patricia Ganz.

Source Courtesy UCLA

WASHINGTON – Few physicians feel prepared to interpret the findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

“There's a lot of confusion between these services and medical care,” said Dr. Patricia Ganz. DTC companies may say that test results are for educational and research purposes only and that they cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are “in fact being very much treated as medical information.”

The difference between how the tests are marketed and what's feasible in clinical practice point to a “number of risks to the clinical encounter,” said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value, the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report, and a false sense of security when a test result indicates “low risk.”

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

In the same reports, national surveys of consumers in the same periods showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said that they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had at least one patient who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, said Joseph McInerney, who serves as director executive director of the National Coalition for Health Professional Education in Genetics.

A study of two open-access and seven general-subscription genetics resources online found that in answering four clinical questions about each of five common genetic conditions, the resources provided complete information only one-third of the time, and in just as many instances provided no information (Genet. Med. 2008;10:659-67).

These results may reflect deficiencies in training in clinical genetics, he said.

Dr. Ganz noted that when physicians advise patients about their DTC test results, it is unclear if the addition of genetic information to family history actually promotes appropriate behavior change.

“We need scientific guidance on these tests that can be linked to effective screening strategies. I think doing them in isolation and not doing studies to see if it changes behavior or changes outcome is false advertising,” commented Dr. Ganz.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

“We need scientific guidance on these [DTC] tests,” says Dr. Patricia Ganz.

Source Courtesy UCLA

A divergence in the age-related memory performance of individuals according to their apolipoprotein e4 allele status begins around the age of 55-60 years in neuropsychologic testing, according to a longitudinal analysis of 815 individuals.

The divergence in memory performance may “date the onset of cognitive decline due to Alzheimer's disease for the first time,” said Dr. Richard J. Caselli, who reported the findings with his colleagues in the July 16 issue of the New England Journal of Medicine.

“We're following people before they're changing and have captured the change point,” said Dr. Caselli of the Mayo Clinic, Scottsdale, Ariz., noting that one might be able to detect Alzheimer's disease–related changes even earlier with imaging or at a pathologic, microscopic level.

Dr. Caselli and his associates followed 498 noncarriers of the apolipoprotein e4 (APOE e4) allele and 79 homozygous APOE e4 and 238 heterozygous APOE e4 carriers during a period of about 5 years in either the Arizona APOE cohort or the Arizona Alzheimer's Disease Center cohort. The patients' ages ranged from 21 to 97 years. All of the e4 heterozygotes carried an APOE e3 allele, rather than an e2 allele, which is known to be protective against Alzheimer's disease (N. Engl. J. Med. 2009;361:255-63).

In analyses that isolated the longitudinal aspect of age on cognitive measures in cross-sectional and longitudinal data, the researchers found that APOE e4 carriers had significantly greater predicted decline on the Auditory-Verbal Learning Test–the primary end point of the study–beginning in their 50s, compared with the predicted annual decline of noncarriers beginning in their 70s. This decline in memory performance was significantly correlated with a trend in APOE e4 allele dose on the Auditory-Verbal Learning Test, although the test results were only directly significant for the comparison between APOE e4 homozygotes and noncarriers.

“Our findings suggest that the APOE e4 allele affects age-related memory performance prior to the symptomatic presentation of mild cognitive impairment and dementia. That memory rather than another measure shows the earliest decline suggests that accelerated memory decline among persons with the APOE e4 allele may be caused by subclinical Alzheimer's disease,” Dr. Caselli said in an interview. “Also consistent with this possibility was the observation that visuospatial function subsequently decreased in homozygous carriers of the APOE e4 allele.”

A previous study by this group of investigators that was led by Dr. Eric Reiman of the Banner Alzheimer's Institute and the Translational Genomics Research Institute, Phoenix, showed that amyloid levels in the brain correlated with an individual's dose of the APOE e4 allele. The frontotemporal region of the brain was the most heavily affected by amyloid deposition, and it was the site of the greatest correlation with APOE e4 dose. But medial temporal regions–the sites of memory loss–were much less affected.

Dr. Caselli reported receiving consulting fees from Myriad Pharmaceuticals and Medication, as well as having an equity interest in Pfizer Inc.

'We're following people before they're changing and have captured the change point.'

Source Dr. Caselli

A divergence in the age-related memory performance of individuals according to their apolipoprotein e4 allele status begins around the age of 55-60 years in neuropsychologic testing, according to a longitudinal analysis of 815 individuals.

The divergence in memory performance may “date the onset of cognitive decline due to Alzheimer's disease for the first time,” said Dr. Richard J. Caselli, who reported the findings with his colleagues in the July 16 issue of the New England Journal of Medicine.

“We're following people before they're changing and have captured the change point,” said Dr. Caselli of the Mayo Clinic, Scottsdale, Ariz., noting that one might be able to detect Alzheimer's disease–related changes even earlier with imaging or at a pathologic, microscopic level.

Dr. Caselli and his associates followed 498 noncarriers of the apolipoprotein e4 (APOE e4) allele and 79 homozygous APOE e4 and 238 heterozygous APOE e4 carriers during a period of about 5 years in either the Arizona APOE cohort or the Arizona Alzheimer's Disease Center cohort. The patients' ages ranged from 21 to 97 years. All of the e4 heterozygotes carried an APOE e3 allele, rather than an e2 allele, which is known to be protective against Alzheimer's disease (N. Engl. J. Med. 2009;361:255-63).

In analyses that isolated the longitudinal aspect of age on cognitive measures in cross-sectional and longitudinal data, the researchers found that APOE e4 carriers had significantly greater predicted decline on the Auditory-Verbal Learning Test–the primary end point of the study–beginning in their 50s, compared with the predicted annual decline of noncarriers beginning in their 70s. This decline in memory performance was significantly correlated with a trend in APOE e4 allele dose on the Auditory-Verbal Learning Test, although the test results were only directly significant for the comparison between APOE e4 homozygotes and noncarriers.

“Our findings suggest that the APOE e4 allele affects age-related memory performance prior to the symptomatic presentation of mild cognitive impairment and dementia. That memory rather than another measure shows the earliest decline suggests that accelerated memory decline among persons with the APOE e4 allele may be caused by subclinical Alzheimer's disease,” Dr. Caselli said in an interview. “Also consistent with this possibility was the observation that visuospatial function subsequently decreased in homozygous carriers of the APOE e4 allele.”

A previous study by this group of investigators that was led by Dr. Eric Reiman of the Banner Alzheimer's Institute and the Translational Genomics Research Institute, Phoenix, showed that amyloid levels in the brain correlated with an individual's dose of the APOE e4 allele. The frontotemporal region of the brain was the most heavily affected by amyloid deposition, and it was the site of the greatest correlation with APOE e4 dose. But medial temporal regions–the sites of memory loss–were much less affected.

Dr. Caselli reported receiving consulting fees from Myriad Pharmaceuticals and Medication, as well as having an equity interest in Pfizer Inc.

'We're following people before they're changing and have captured the change point.'

Source Dr. Caselli

A divergence in the age-related memory performance of individuals according to their apolipoprotein e4 allele status begins around the age of 55-60 years in neuropsychologic testing, according to a longitudinal analysis of 815 individuals.

The divergence in memory performance may “date the onset of cognitive decline due to Alzheimer's disease for the first time,” said Dr. Richard J. Caselli, who reported the findings with his colleagues in the July 16 issue of the New England Journal of Medicine.

“We're following people before they're changing and have captured the change point,” said Dr. Caselli of the Mayo Clinic, Scottsdale, Ariz., noting that one might be able to detect Alzheimer's disease–related changes even earlier with imaging or at a pathologic, microscopic level.

Dr. Caselli and his associates followed 498 noncarriers of the apolipoprotein e4 (APOE e4) allele and 79 homozygous APOE e4 and 238 heterozygous APOE e4 carriers during a period of about 5 years in either the Arizona APOE cohort or the Arizona Alzheimer's Disease Center cohort. The patients' ages ranged from 21 to 97 years. All of the e4 heterozygotes carried an APOE e3 allele, rather than an e2 allele, which is known to be protective against Alzheimer's disease (N. Engl. J. Med. 2009;361:255-63).

In analyses that isolated the longitudinal aspect of age on cognitive measures in cross-sectional and longitudinal data, the researchers found that APOE e4 carriers had significantly greater predicted decline on the Auditory-Verbal Learning Test–the primary end point of the study–beginning in their 50s, compared with the predicted annual decline of noncarriers beginning in their 70s. This decline in memory performance was significantly correlated with a trend in APOE e4 allele dose on the Auditory-Verbal Learning Test, although the test results were only directly significant for the comparison between APOE e4 homozygotes and noncarriers.

“Our findings suggest that the APOE e4 allele affects age-related memory performance prior to the symptomatic presentation of mild cognitive impairment and dementia. That memory rather than another measure shows the earliest decline suggests that accelerated memory decline among persons with the APOE e4 allele may be caused by subclinical Alzheimer's disease,” Dr. Caselli said in an interview. “Also consistent with this possibility was the observation that visuospatial function subsequently decreased in homozygous carriers of the APOE e4 allele.”

A previous study by this group of investigators that was led by Dr. Eric Reiman of the Banner Alzheimer's Institute and the Translational Genomics Research Institute, Phoenix, showed that amyloid levels in the brain correlated with an individual's dose of the APOE e4 allele. The frontotemporal region of the brain was the most heavily affected by amyloid deposition, and it was the site of the greatest correlation with APOE e4 dose. But medial temporal regions–the sites of memory loss–were much less affected.

Dr. Caselli reported receiving consulting fees from Myriad Pharmaceuticals and Medication, as well as having an equity interest in Pfizer Inc.

'We're following people before they're changing and have captured the change point.'

Source Dr. Caselli

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a recent study.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM). The association between UV radiation and DM was strongest in a collective group of European, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between PM and DM. These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both PM and DM patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

PM occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%). Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

The investigators noted that the study may be limited by the following: referral bias; the use of state-level UV radiation intensities; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences. Dr. Werth said she had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the prevalence of dermatomyositis in women, shown here.

Source Courtesy Dr. Victoria P. Werth

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a recent study.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM). The association between UV radiation and DM was strongest in a collective group of European, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between PM and DM. These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both PM and DM patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

PM occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%). Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

The investigators noted that the study may be limited by the following: referral bias; the use of state-level UV radiation intensities; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences. Dr. Werth said she had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the prevalence of dermatomyositis in women, shown here.

Source Courtesy Dr. Victoria P. Werth

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a recent study.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM). The association between UV radiation and DM was strongest in a collective group of European, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between PM and DM. These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both PM and DM patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

PM occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%). Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

The investigators noted that the study may be limited by the following: referral bias; the use of state-level UV radiation intensities; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences. Dr. Werth said she had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the prevalence of dermatomyositis in women, shown here.

Source Courtesy Dr. Victoria P. Werth

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about any health risks identified by DTC genetic tests.

"There's a lot of confusion between these services and medical care," Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are "in fact being very much treated as medical information."

The difference between how the tests are marketed and what's feasible in clinical practice point to a "number of risks to the clinical encounter," said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value and the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report.

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

The questions in each survey were "not completely comparable" between time periods. The 2006 survey questions focused on nutrigenomic tests, while the 2008 questions centered on genetic tests for complex diseases that used data from genome-wide association studies. Of the surveyed physicians, 50% were aware of the nutrigenomic tests and 42% were aware of the tests for complex diseases.

In the same reports, national surveys of consumers showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had one or more patients who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

Families with genetic conditions do not appear confident about their provider's knowledge of genetics.

Source Mr. McInerney

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

"There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies," he said. "Genetics has clearly moved beyond that into the realm of common, complex disease."

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5). General concepts accounted for 86% of the instruction in genetics, with little focus on practical applications. Medical genetics was taught as a stand-alone course (46%) or as part of another course (54%).

The two schools with integrated genetics programs are the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program.

The Vermont Integrated Curriculum aims to teach students to "think of patients as not individuals but members of a family in a community—part of their genetic background—and also frame their decision making within the boundaries of medical ethics and evidence-based medicine," said Dr. Leah Burke, a clinical geneticist and director of a course on clinical decision making.

The Johns Hopkins Genes to Society program integrates basic, clinical, and social sciences and seeks to show how to improve societal health outcomes by combining an understanding of human variability with knowledge from the social and behavioral sciences, as well as public health and policy.

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about any health risks identified by DTC genetic tests.

"There's a lot of confusion between these services and medical care," Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are "in fact being very much treated as medical information."

The difference between how the tests are marketed and what's feasible in clinical practice point to a "number of risks to the clinical encounter," said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value and the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report.

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

The questions in each survey were "not completely comparable" between time periods. The 2006 survey questions focused on nutrigenomic tests, while the 2008 questions centered on genetic tests for complex diseases that used data from genome-wide association studies. Of the surveyed physicians, 50% were aware of the nutrigenomic tests and 42% were aware of the tests for complex diseases.

In the same reports, national surveys of consumers showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had one or more patients who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

Families with genetic conditions do not appear confident about their provider's knowledge of genetics.

Source Mr. McInerney

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

"There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies," he said. "Genetics has clearly moved beyond that into the realm of common, complex disease."

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5). General concepts accounted for 86% of the instruction in genetics, with little focus on practical applications. Medical genetics was taught as a stand-alone course (46%) or as part of another course (54%).

The two schools with integrated genetics programs are the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program.

The Vermont Integrated Curriculum aims to teach students to "think of patients as not individuals but members of a family in a community—part of their genetic background—and also frame their decision making within the boundaries of medical ethics and evidence-based medicine," said Dr. Leah Burke, a clinical geneticist and director of a course on clinical decision making.

The Johns Hopkins Genes to Society program integrates basic, clinical, and social sciences and seeks to show how to improve societal health outcomes by combining an understanding of human variability with knowledge from the social and behavioral sciences, as well as public health and policy.

WASHINGTON — Few physicians feel prepared to interpret findings from direct-to-consumer genetic tests and incorporate the results into clinical practice, according to speakers at a National Academy of Sciences workshop on DTC genetic testing.

Surveys and anecdotal accounts discussed at the meeting cast doubt on the idea that physicians will be able to help consumers decide what to do about any health risks identified by DTC genetic tests.

"There's a lot of confusion between these services and medical care," Dr. Patricia Ganz said. DTC companies may say that test results are for educational and research purposes only, and cannot be used for diagnostic purposes because the tests have not been validated for clinical use, but the results are "in fact being very much treated as medical information."

The difference between how the tests are marketed and what's feasible in clinical practice point to a "number of risks to the clinical encounter," said Dr. Ganz, professor of health services and medicine at the University of California, Los Angeles. Possible problems include a demand for screening tests that have no proven clinical value and the perception that a physician is unsympathetic or lacking in knowledge when reviewing a patient's DTC genetic test report.

Some physicians currently use genetic tests with known clinical value, such as tests for blood disorders or prenatal risk assessment, Dr. Ganz said. But many physicians have little need for test results about cancer predisposition or other genetic syndromes, and are even less likely to be prepared to interpret DTC genetic test reports derived from case-control association studies and genome-wide association studies.

Published reports indicate that physicians obtain most of their information about DTC genetic testing through the media, Katrina Goddard, Ph.D., of the Kaiser Permanente Center for Health Research, Portland, Ore., said at the workshop.

An online physician survey, called DocStyles, included 1,250 respondents (response rate 61%) in 2006 and 1,880 (response rate 22%) in 2008. More than 60% of the respondents reported getting information about DTC testing from the media, and less than 30% said they obtain information about such testing from other sources (Genet. Med. 2007;9:510-7; Genet. Med. 2009;11:595).

The questions in each survey were "not completely comparable" between time periods. The 2006 survey questions focused on nutrigenomic tests, while the 2008 questions centered on genetic tests for complex diseases that used data from genome-wide association studies. Of the surveyed physicians, 50% were aware of the nutrigenomic tests and 42% were aware of the tests for complex diseases.

In the same reports, national surveys of consumers showed that 14% were aware of the tests covered in the 2006 survey, and 22% were aware of the tests in the 2008 survey, but less than 1% used the tests.

Nearly half of the physicians who said they were aware of DTC genetic tests said they had patients with questions about the tests. About 15% of these physicians had one or more patients who brought in their test results for discussion. Some aspect of the patient's care changed in 75% of these encounters, according to the survey.

At the workshop, Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, said that individuals and families with genetic conditions also do not appear confident about their provider's knowledge of genetics.

In a survey of 5,915 respondents conducted by the Genetic Alliance, an advocacy group, more than 30% rated as poor their provider's understanding of genetics and ability to deal with genetics-related management issues (Genet. Med. 2007;9:259-67).

Physicians who search for resources to help in interpreting DTC test results are likely to turn to point-of-care clinical decision tools. But current versions of these tools often lack relevant information and are inefficient to use, Mr. McInerney said.

None of the speakers disclosed conflicts of interest with DTC genetic testing companies.

Families with genetic conditions do not appear confident about their provider's knowledge of genetics.

Source Mr. McInerney

Only two U.S. medical schools have integrated medical genetics into their curricula for all 4 years, which suggests there are not enough professors and instructors sufficiently well trained in genetics to connect basic and clinical science during training, Mr. McInerney said at the workshop.

"There is a perception among many health care providers that genetics is still quite circumscribed by traditional, Mendelian, rare genetic disease and chromosomal anomalies," he said. "Genetics has clearly moved beyond that into the realm of common, complex disease."

He noted that a 2005 survey of 149 U.S. and Canadian course directors in medical genetics or curricular deans in medical schools found that 77% of the schools taught medical genetics in the first year, but only 47% incorporated it into the third or fourth year (Acad. Med. 2007;82:441-5). General concepts accounted for 86% of the instruction in genetics, with little focus on practical applications. Medical genetics was taught as a stand-alone course (46%) or as part of another course (54%).

The two schools with integrated genetics programs are the University of Vermont's Vermont Integrated Curriculum and Johns Hopkins University's Genes to Society program.

The Vermont Integrated Curriculum aims to teach students to "think of patients as not individuals but members of a family in a community—part of their genetic background—and also frame their decision making within the boundaries of medical ethics and evidence-based medicine," said Dr. Leah Burke, a clinical geneticist and director of a course on clinical decision making.

The Johns Hopkins Genes to Society program integrates basic, clinical, and social sciences and seeks to show how to improve societal health outcomes by combining an understanding of human variability with knowledge from the social and behavioral sciences, as well as public health and policy.

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a study published in Arthritis & Rheumatism.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM).

The association between UV radiation and DM was strongest in a collective group of white, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

“This is the best study that I've seen so far in reference to dermatomyositis” and exposure to UV radiation, she said.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between polymyositis and dermatomyositis.

These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both polymyositis and dermatomyositis patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

Polymyositis occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%), the study showed.

Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

Evidence from a previous study has shown that the dose of UV radiation required to induce immunosuppression is three times higher in women than in men, which may mean “other mechanisms would need to be operative to potentially explain how UV radiation preferentially results in the development of dermatomyositis and anti-Mi-2 autoantibodies in women,” the investigators wrote.

They noted that “it is tempting to speculate that the development of DM and DM-specific anti-Mi-2 autoantibodies, which are associated with certain major histocompatibility loci, is related to UV-induced increased expression of target autoantigens combined with altered immune responses in genetically susceptible individuals.”

The fact that not all dermatomyositis patients have anti-Mi-2 autoantibodies but still develop dermatomyositis means that other environmental risk factors outside of UV radiation must be operating to contribute to the development of the disease, said Dr. Steven Ytterberg of the division of rheumatology at the Mayo Clinic, Rochester, Minn.

It would be worthwhile to determine if DM patients with anti-Mi-2 autoantibodies are more likely to get clinical disease flares from UV radiation exposure than are those who do not have the autoantibodies. Dermatomyositis patients who are negative for anti-Mi-2 may have a different environmental risk factor, Dr. Ytterberg said in an interview.

The investigators noted that the study may be limited by the following: referral bias, because patients with myositis who are seen at referral centers may not be representative of the larger population of patients with myositis; the use of state-level UV radiation intensities, which can vary considerably from one part of a state to another; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences.

Dr. Werth and Dr. Ytterberg said they had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the preva-lence of dermatomyositis in women, such as this hand involvement.

Source Courtesy Dr. Victoria P. Werth

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a study published in Arthritis & Rheumatism.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM).

The association between UV radiation and DM was strongest in a collective group of white, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

“This is the best study that I've seen so far in reference to dermatomyositis” and exposure to UV radiation, she said.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between polymyositis and dermatomyositis.

These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both polymyositis and dermatomyositis patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

Polymyositis occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%), the study showed.

Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

Evidence from a previous study has shown that the dose of UV radiation required to induce immunosuppression is three times higher in women than in men, which may mean “other mechanisms would need to be operative to potentially explain how UV radiation preferentially results in the development of dermatomyositis and anti-Mi-2 autoantibodies in women,” the investigators wrote.

They noted that “it is tempting to speculate that the development of DM and DM-specific anti-Mi-2 autoantibodies, which are associated with certain major histocompatibility loci, is related to UV-induced increased expression of target autoantigens combined with altered immune responses in genetically susceptible individuals.”

The fact that not all dermatomyositis patients have anti-Mi-2 autoantibodies but still develop dermatomyositis means that other environmental risk factors outside of UV radiation must be operating to contribute to the development of the disease, said Dr. Steven Ytterberg of the division of rheumatology at the Mayo Clinic, Rochester, Minn.

It would be worthwhile to determine if DM patients with anti-Mi-2 autoantibodies are more likely to get clinical disease flares from UV radiation exposure than are those who do not have the autoantibodies. Dermatomyositis patients who are negative for anti-Mi-2 may have a different environmental risk factor, Dr. Ytterberg said in an interview.

The investigators noted that the study may be limited by the following: referral bias, because patients with myositis who are seen at referral centers may not be representative of the larger population of patients with myositis; the use of state-level UV radiation intensities, which can vary considerably from one part of a state to another; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences.

Dr. Werth and Dr. Ytterberg said they had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the preva-lence of dermatomyositis in women, such as this hand involvement.

Source Courtesy Dr. Victoria P. Werth

The intensity of exposure to ambient ultraviolet radiation appears to determine the prevalence of dermatomyositis and an autoantibody specific to the disease in women, based on a study published in Arthritis & Rheumatism.

The UV Index across geographical regions of the United States also significantly correlated with the presence of an autoantibody unique to dermatomyositis (DM)—known as anti-Mi-2—and not to autoantibodies more commonly found in polymyositis (PM).

The association between UV radiation and DM was strongest in a collective group of white, Hispanic, and Asian American women, but it also was significant among black women.

This is the first study to show evidence of the influence of sex on the association between UV radiation and autoimmune disorders, commented Dr. Victoria P. Werth, professor of dermatology at the University of Pennsylvania, Philadelphia, and chief of dermatology at the Philadelphia Veterans Affairs Medical Center.

“This is the best study that I've seen so far in reference to dermatomyositis” and exposure to UV radiation, she said.

The study brings up many “intriguing kinds of things that we don't totally understand,” such as differences in risk factors and responses to UV radiation between men and women and between polymyositis and dermatomyositis.

These types of “interesting epidemiologic observations” may help in the future to understand more about the differences in pathogenesis, Dr. Werth said in an interview.

In the cross-sectional, retrospective study, Dr. Lori A. Love of the National Institute of Environmental Health Sciences and her coinvestigators gathered clinical data and serum samples from 202 PM and 178 DM patients at referral centers across the United States.

The investigators detected myositis-specific autoantibodies in 172 patients (45%), some of which were found in both polymyositis and dermatomyositis patients, whereas others were found only in each particular phenotypic type of myositis, such as anti-SRP in 21 PM patients and anti-Mi-2 in 23 DM patients.

Polymyositis occurred in a significantly greater proportion of black patients (66%) than among nonblack patients (48%), the study showed.

Most (86%) of the patients with anti-SRP antibodies were black, Dr. Love and her associates reported (Arthritis Rheum. 2009;60:2499-504).

The proportion of patients in the study who had anti-Mi-2 autoantibodies was significantly associated with the UV Index for the seven regions (comprising 37 states) that the investigators categorized according to shared geoclimatic factors. However, the UV Index was not associated with the proportion of patients with DM. Both of these comparisons proved to be significant for women but not for men.

Evidence from a previous study has shown that the dose of UV radiation required to induce immunosuppression is three times higher in women than in men, which may mean “other mechanisms would need to be operative to potentially explain how UV radiation preferentially results in the development of dermatomyositis and anti-Mi-2 autoantibodies in women,” the investigators wrote.

They noted that “it is tempting to speculate that the development of DM and DM-specific anti-Mi-2 autoantibodies, which are associated with certain major histocompatibility loci, is related to UV-induced increased expression of target autoantigens combined with altered immune responses in genetically susceptible individuals.”

The fact that not all dermatomyositis patients have anti-Mi-2 autoantibodies but still develop dermatomyositis means that other environmental risk factors outside of UV radiation must be operating to contribute to the development of the disease, said Dr. Steven Ytterberg of the division of rheumatology at the Mayo Clinic, Rochester, Minn.

It would be worthwhile to determine if DM patients with anti-Mi-2 autoantibodies are more likely to get clinical disease flares from UV radiation exposure than are those who do not have the autoantibodies. Dermatomyositis patients who are negative for anti-Mi-2 may have a different environmental risk factor, Dr. Ytterberg said in an interview.

The investigators noted that the study may be limited by the following: referral bias, because patients with myositis who are seen at referral centers may not be representative of the larger population of patients with myositis; the use of state-level UV radiation intensities, which can vary considerably from one part of a state to another; the lack of accounting for individual-level exposure; differences in UV radiation exposure at different locations over time; and the use of personal photoprotective measures.

The study was funded in part by the intramural research programs of the National Institute of Environmental Health Sciences.

Dr. Werth and Dr. Ytterberg said they had no relevant disclosures.

The intensity of UV radiation exposure may be tied to the preva-lence of dermatomyositis in women, such as this hand involvement.

Source Courtesy Dr. Victoria P. Werth

Manufacturing issues may limit the number of vaccine doses against novel influenza A(H1N1) that will be available when immunization programs begin around mid-October, officials from the Department of Health and Human Services told members of the National Biodefense Science Board in a public teleconference.

But clinical trial testing of the inactivated and live attenuated virus vaccines already are underway, and programs for distributing the vaccines and conducting surveillance should be in place when the vaccines are ready, the officials said.

Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority of HHS, reported that, for the most part, vaccine production and testing are on schedule. All five vaccine manufacturers recently received their potency assay reagents so they can know how much vaccine they have produced. But an unanticipated difficulty in bulk production of the live attenuated virus vaccine has slowed its progress.

Although vaccination programs still are slated for mid-October, the number of doses that will be available by then has been lowered from 120 million to 45 million, with 20 million doses coming out each week afterward, Dr. Robinson said. The reduction in doses is a result of lower than expected vaccine yield, compared with previous yields with seasonal flu vaccines. One manufacturer also had obligations to produce vaccine for Australia ahead of other clients. Another manufacturer's difficulty in finishing up its orders of seasonal influenza vaccine has affected the time line for novel H1N1 vaccine production.

The federal government already has bought 190 million vaccine doses and, if needed, 120 million adjuvant doses. It also has stockpiled 84 million treatment courses of antivirals and another 3 million are expected to arrive soon. In May, states were able to purchase 11 million antiviral treatment courses; another 2 million have been recently purchased, he said.

The National Immunization Survey will be set to begin collecting immunization data as early as Oct. 10 for weekly reports of national coverage estimates. While clinical trials will provide data on reactogenicity to the vaccine, rare adverse events will be monitored through the Vaccine Adverse Event Reporting System and the population-based Vaccine Safety Datalink. Vaccine safety in the military will be collected though the Defense Medical Surveillance System, a collaboration between the Department of Defense and the Food and Drug Administration. A special surveillance program also will be set up for Guillain-Barré syndrome.

Dr. Daniel B. Jernigan, deputy director of the CDC's National Center for Immunization and Respiratory Diseases, noted that public health laboratories will focus their testing more on surveillance than clinical testing capacity.

Manufacturing issues may limit the number of vaccine doses against novel influenza A(H1N1) that will be available when immunization programs begin around mid-October, officials from the Department of Health and Human Services told members of the National Biodefense Science Board in a public teleconference.

But clinical trial testing of the inactivated and live attenuated virus vaccines already are underway, and programs for distributing the vaccines and conducting surveillance should be in place when the vaccines are ready, the officials said.

Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority of HHS, reported that, for the most part, vaccine production and testing are on schedule. All five vaccine manufacturers recently received their potency assay reagents so they can know how much vaccine they have produced. But an unanticipated difficulty in bulk production of the live attenuated virus vaccine has slowed its progress.

Although vaccination programs still are slated for mid-October, the number of doses that will be available by then has been lowered from 120 million to 45 million, with 20 million doses coming out each week afterward, Dr. Robinson said. The reduction in doses is a result of lower than expected vaccine yield, compared with previous yields with seasonal flu vaccines. One manufacturer also had obligations to produce vaccine for Australia ahead of other clients. Another manufacturer's difficulty in finishing up its orders of seasonal influenza vaccine has affected the time line for novel H1N1 vaccine production.

The federal government already has bought 190 million vaccine doses and, if needed, 120 million adjuvant doses. It also has stockpiled 84 million treatment courses of antivirals and another 3 million are expected to arrive soon. In May, states were able to purchase 11 million antiviral treatment courses; another 2 million have been recently purchased, he said.

The National Immunization Survey will be set to begin collecting immunization data as early as Oct. 10 for weekly reports of national coverage estimates. While clinical trials will provide data on reactogenicity to the vaccine, rare adverse events will be monitored through the Vaccine Adverse Event Reporting System and the population-based Vaccine Safety Datalink. Vaccine safety in the military will be collected though the Defense Medical Surveillance System, a collaboration between the Department of Defense and the Food and Drug Administration. A special surveillance program also will be set up for Guillain-Barré syndrome.

Dr. Daniel B. Jernigan, deputy director of the CDC's National Center for Immunization and Respiratory Diseases, noted that public health laboratories will focus their testing more on surveillance than clinical testing capacity.

Manufacturing issues may limit the number of vaccine doses against novel influenza A(H1N1) that will be available when immunization programs begin around mid-October, officials from the Department of Health and Human Services told members of the National Biodefense Science Board in a public teleconference.

But clinical trial testing of the inactivated and live attenuated virus vaccines already are underway, and programs for distributing the vaccines and conducting surveillance should be in place when the vaccines are ready, the officials said.

Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority of HHS, reported that, for the most part, vaccine production and testing are on schedule. All five vaccine manufacturers recently received their potency assay reagents so they can know how much vaccine they have produced. But an unanticipated difficulty in bulk production of the live attenuated virus vaccine has slowed its progress.

Although vaccination programs still are slated for mid-October, the number of doses that will be available by then has been lowered from 120 million to 45 million, with 20 million doses coming out each week afterward, Dr. Robinson said. The reduction in doses is a result of lower than expected vaccine yield, compared with previous yields with seasonal flu vaccines. One manufacturer also had obligations to produce vaccine for Australia ahead of other clients. Another manufacturer's difficulty in finishing up its orders of seasonal influenza vaccine has affected the time line for novel H1N1 vaccine production.

The federal government already has bought 190 million vaccine doses and, if needed, 120 million adjuvant doses. It also has stockpiled 84 million treatment courses of antivirals and another 3 million are expected to arrive soon. In May, states were able to purchase 11 million antiviral treatment courses; another 2 million have been recently purchased, he said.

The National Immunization Survey will be set to begin collecting immunization data as early as Oct. 10 for weekly reports of national coverage estimates. While clinical trials will provide data on reactogenicity to the vaccine, rare adverse events will be monitored through the Vaccine Adverse Event Reporting System and the population-based Vaccine Safety Datalink. Vaccine safety in the military will be collected though the Defense Medical Surveillance System, a collaboration between the Department of Defense and the Food and Drug Administration. A special surveillance program also will be set up for Guillain-Barré syndrome.

Dr. Daniel B. Jernigan, deputy director of the CDC's National Center for Immunization and Respiratory Diseases, noted that public health laboratories will focus their testing more on surveillance than clinical testing capacity.