Mike Bock

Semen quality and partner pregnancy rates are favorable among men who have a vasectomy reversal at least 10 years after the original procedure, new research suggests.

"Although the VOI [vasal obstructive interval] has a significant effect on the type of VR [vasectomy reversal] required, provided a surgeon is proficient with both vasovasostomy and vasoepididymostomy, favorable semen parameters and patency and pregnancy rates can be achieved in men with a VOI [of more than] 10 years. Couples should not be discouraged from considering VR solely because of the VOI," wrote Dr. Ethan D. Grober of Mount Sinai and Women’s College Hospital, Toronto, and his associates.

The research, published in Urology (2014;83:320-3), examined the postoperative semen parameters, patency rates, and partner pregnancy outcomes of 535 men, 177 (or 33%) of whom had VOIs of more than 10 years. The patients were divided into four groups based on VOI duration: less than 10 years, 10-15 years, 15-20 years, and more than 20 years.

Partner pregnancy rates among men with a VOI of more than 10 years ranged from 24% to 39%, compared with 43% when the VOI was less than 10 years. Differences in pregnancy rates between age groups were likely influenced by factors such as age, reproductive health status, type of procedure, and overall sperm quality after surgery.

Patients underwent a vasovasostomy, a vasoepididymostomy, or a complete vasectomy reversal, with similar surgical techniques used for each procedure. Patency rates were around 90% for patients with a VOI of less than 10 years, compared with 87-92% for those with a VOI of 10-19 years.

Mean sperm counts were not significantly different among the four groups when stratified by the VOI. Mean postoperative counts of more than 20 million sperm per milliliter were achieved in all groups after VR, irrespective of the VOI. The percentage of motile sperm decreased (ranging from 38% to 21%) and the percentage of normal morphology showed a trend toward a decrease as the VOI increased.

The investigators declared that had no relevant financial interests.

[email protected]

Semen quality and partner pregnancy rates are favorable among men who have a vasectomy reversal at least 10 years after the original procedure, new research suggests.

"Although the VOI [vasal obstructive interval] has a significant effect on the type of VR [vasectomy reversal] required, provided a surgeon is proficient with both vasovasostomy and vasoepididymostomy, favorable semen parameters and patency and pregnancy rates can be achieved in men with a VOI [of more than] 10 years. Couples should not be discouraged from considering VR solely because of the VOI," wrote Dr. Ethan D. Grober of Mount Sinai and Women’s College Hospital, Toronto, and his associates.

The research, published in Urology (2014;83:320-3), examined the postoperative semen parameters, patency rates, and partner pregnancy outcomes of 535 men, 177 (or 33%) of whom had VOIs of more than 10 years. The patients were divided into four groups based on VOI duration: less than 10 years, 10-15 years, 15-20 years, and more than 20 years.

Partner pregnancy rates among men with a VOI of more than 10 years ranged from 24% to 39%, compared with 43% when the VOI was less than 10 years. Differences in pregnancy rates between age groups were likely influenced by factors such as age, reproductive health status, type of procedure, and overall sperm quality after surgery.

Patients underwent a vasovasostomy, a vasoepididymostomy, or a complete vasectomy reversal, with similar surgical techniques used for each procedure. Patency rates were around 90% for patients with a VOI of less than 10 years, compared with 87-92% for those with a VOI of 10-19 years.

Mean sperm counts were not significantly different among the four groups when stratified by the VOI. Mean postoperative counts of more than 20 million sperm per milliliter were achieved in all groups after VR, irrespective of the VOI. The percentage of motile sperm decreased (ranging from 38% to 21%) and the percentage of normal morphology showed a trend toward a decrease as the VOI increased.

The investigators declared that had no relevant financial interests.

[email protected]

Semen quality and partner pregnancy rates are favorable among men who have a vasectomy reversal at least 10 years after the original procedure, new research suggests.

"Although the VOI [vasal obstructive interval] has a significant effect on the type of VR [vasectomy reversal] required, provided a surgeon is proficient with both vasovasostomy and vasoepididymostomy, favorable semen parameters and patency and pregnancy rates can be achieved in men with a VOI [of more than] 10 years. Couples should not be discouraged from considering VR solely because of the VOI," wrote Dr. Ethan D. Grober of Mount Sinai and Women’s College Hospital, Toronto, and his associates.

The research, published in Urology (2014;83:320-3), examined the postoperative semen parameters, patency rates, and partner pregnancy outcomes of 535 men, 177 (or 33%) of whom had VOIs of more than 10 years. The patients were divided into four groups based on VOI duration: less than 10 years, 10-15 years, 15-20 years, and more than 20 years.

Partner pregnancy rates among men with a VOI of more than 10 years ranged from 24% to 39%, compared with 43% when the VOI was less than 10 years. Differences in pregnancy rates between age groups were likely influenced by factors such as age, reproductive health status, type of procedure, and overall sperm quality after surgery.

Patients underwent a vasovasostomy, a vasoepididymostomy, or a complete vasectomy reversal, with similar surgical techniques used for each procedure. Patency rates were around 90% for patients with a VOI of less than 10 years, compared with 87-92% for those with a VOI of 10-19 years.

Mean sperm counts were not significantly different among the four groups when stratified by the VOI. Mean postoperative counts of more than 20 million sperm per milliliter were achieved in all groups after VR, irrespective of the VOI. The percentage of motile sperm decreased (ranging from 38% to 21%) and the percentage of normal morphology showed a trend toward a decrease as the VOI increased.

The investigators declared that had no relevant financial interests.

[email protected]

A global coalition of 26 countries, including the United States, was launched Feb. 13 to improve international efforts focusing on prevention, detection, and response to infectious global health threats.

The United States aims to lead the way in preventing epidemics, monitoring potential threats to global health, detecting and responding to disease outbreaks, and bolstering partnering countries’ ability to respond to such threats, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said during a press briefing.

"The United States and the world can and must do more to prevent, detect, and respond to outbreaks as early and as effectively as possible," Dr. Frieden said. "The CDC conducted two global health security demonstration projects last year in partnership with Vietnam and Uganda to strengthen laboratory systems, develop strong public health emergency operations centers, and create real-time data sharing in health emergencies. The CDC is committed to replicate the successes in these two projects in ten additional countries this year."

© CDC

A key element to the initiative is the creation and expansion of international partnerships. Laura Holgate, a senior director at the National Security Council, said that many of the items in the agenda are in line with rules already established by the World Health Organization.

In 2005, the WHO created the International Health Regulations standards, a gauge by which countries can measure preparedness for emerging disease threats and outbreaks, as benchmarks toward progress.

As of 2012, only 16% of countries reported reaching full compliance with the core IHR competencies, a statistic cited by both Dr. Frieden and Ms. Holgate to justify the new efforts.

"In our interconnected world, we are all vulnerable. ... [Infectious outbreaks] are only a plane ride away," Ms. Holgate said.

Despite fears that other nations will not address the agenda proposals, federal officials said the program will put a focus on how each country can bring its health system in line with the IHR standards. And by following the guidelines set forth, the global health community could make a "really big dent" in reducing outbreaks, Ms. Holgate said.

In addition to calling for greater focus on global health issues, the federal government aims to forge stronger interagency ties to aid that could respond to global threats like bioterrorism.

For example, the U.S. Department of Defense plans to innovate in response to bioterrorism, which calls for forming "unprecedented" partnerships with other governmental agencies and channeling resources into U.S. health security efforts, said Assistant Secretary of Defense Andrew C. Weber.

And by building efforts within the country, the United States can show other countries new ways to deal with health threats.

"This is intended to be a shot in the arm that will energize and invigorate the world health agenda," Mr. Weber said.

While exact details are not finalized, Dr. Frieden mentioned a number of proposals in development, including a plan to have emergency-operations centers with trained rapid-response teams and disease monitoring labs located every 200 miles in participating countries.

Around $40 million has been included in the federal government’s fiscal 2014 budget for these efforts; Health & Human Services’ official plan to seek an additional $45 million in fiscal 2015.

[email protected]

A global coalition of 26 countries, including the United States, was launched Feb. 13 to improve international efforts focusing on prevention, detection, and response to infectious global health threats.

The United States aims to lead the way in preventing epidemics, monitoring potential threats to global health, detecting and responding to disease outbreaks, and bolstering partnering countries’ ability to respond to such threats, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said during a press briefing.

"The United States and the world can and must do more to prevent, detect, and respond to outbreaks as early and as effectively as possible," Dr. Frieden said. "The CDC conducted two global health security demonstration projects last year in partnership with Vietnam and Uganda to strengthen laboratory systems, develop strong public health emergency operations centers, and create real-time data sharing in health emergencies. The CDC is committed to replicate the successes in these two projects in ten additional countries this year."

© CDC

A key element to the initiative is the creation and expansion of international partnerships. Laura Holgate, a senior director at the National Security Council, said that many of the items in the agenda are in line with rules already established by the World Health Organization.

In 2005, the WHO created the International Health Regulations standards, a gauge by which countries can measure preparedness for emerging disease threats and outbreaks, as benchmarks toward progress.

As of 2012, only 16% of countries reported reaching full compliance with the core IHR competencies, a statistic cited by both Dr. Frieden and Ms. Holgate to justify the new efforts.

"In our interconnected world, we are all vulnerable. ... [Infectious outbreaks] are only a plane ride away," Ms. Holgate said.

Despite fears that other nations will not address the agenda proposals, federal officials said the program will put a focus on how each country can bring its health system in line with the IHR standards. And by following the guidelines set forth, the global health community could make a "really big dent" in reducing outbreaks, Ms. Holgate said.

In addition to calling for greater focus on global health issues, the federal government aims to forge stronger interagency ties to aid that could respond to global threats like bioterrorism.

For example, the U.S. Department of Defense plans to innovate in response to bioterrorism, which calls for forming "unprecedented" partnerships with other governmental agencies and channeling resources into U.S. health security efforts, said Assistant Secretary of Defense Andrew C. Weber.

And by building efforts within the country, the United States can show other countries new ways to deal with health threats.

"This is intended to be a shot in the arm that will energize and invigorate the world health agenda," Mr. Weber said.

While exact details are not finalized, Dr. Frieden mentioned a number of proposals in development, including a plan to have emergency-operations centers with trained rapid-response teams and disease monitoring labs located every 200 miles in participating countries.

Around $40 million has been included in the federal government’s fiscal 2014 budget for these efforts; Health & Human Services’ official plan to seek an additional $45 million in fiscal 2015.

[email protected]

A global coalition of 26 countries, including the United States, was launched Feb. 13 to improve international efforts focusing on prevention, detection, and response to infectious global health threats.

The United States aims to lead the way in preventing epidemics, monitoring potential threats to global health, detecting and responding to disease outbreaks, and bolstering partnering countries’ ability to respond to such threats, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said during a press briefing.

"The United States and the world can and must do more to prevent, detect, and respond to outbreaks as early and as effectively as possible," Dr. Frieden said. "The CDC conducted two global health security demonstration projects last year in partnership with Vietnam and Uganda to strengthen laboratory systems, develop strong public health emergency operations centers, and create real-time data sharing in health emergencies. The CDC is committed to replicate the successes in these two projects in ten additional countries this year."

© CDC

A key element to the initiative is the creation and expansion of international partnerships. Laura Holgate, a senior director at the National Security Council, said that many of the items in the agenda are in line with rules already established by the World Health Organization.

In 2005, the WHO created the International Health Regulations standards, a gauge by which countries can measure preparedness for emerging disease threats and outbreaks, as benchmarks toward progress.

As of 2012, only 16% of countries reported reaching full compliance with the core IHR competencies, a statistic cited by both Dr. Frieden and Ms. Holgate to justify the new efforts.

"In our interconnected world, we are all vulnerable. ... [Infectious outbreaks] are only a plane ride away," Ms. Holgate said.

Despite fears that other nations will not address the agenda proposals, federal officials said the program will put a focus on how each country can bring its health system in line with the IHR standards. And by following the guidelines set forth, the global health community could make a "really big dent" in reducing outbreaks, Ms. Holgate said.

In addition to calling for greater focus on global health issues, the federal government aims to forge stronger interagency ties to aid that could respond to global threats like bioterrorism.

For example, the U.S. Department of Defense plans to innovate in response to bioterrorism, which calls for forming "unprecedented" partnerships with other governmental agencies and channeling resources into U.S. health security efforts, said Assistant Secretary of Defense Andrew C. Weber.

And by building efforts within the country, the United States can show other countries new ways to deal with health threats.

"This is intended to be a shot in the arm that will energize and invigorate the world health agenda," Mr. Weber said.

While exact details are not finalized, Dr. Frieden mentioned a number of proposals in development, including a plan to have emergency-operations centers with trained rapid-response teams and disease monitoring labs located every 200 miles in participating countries.

Around $40 million has been included in the federal government’s fiscal 2014 budget for these efforts; Health & Human Services’ official plan to seek an additional $45 million in fiscal 2015.

[email protected]

The Endocrine Society is calling for large-scale controlled trials of both testosterone therapy’s effects on older men and the association between testosterone therapy and cardiovascular disease.

The statement comes on the heels of an analysis published in PLoS One by Dr. William D. Finkle and his associates. They found a doubled risk of MIs in men under age 65 years who had preexisting heart conditions and were taking testosterone. In men over age 65 taking testosterone, the MI risk was even greater (PLoS ONE 2015 Jan. 29 [doi:10.1371/journal.pone.0085805]).

Several studies and retrospective analyses connected with the National Institutes of Health and the Veterans Health Care System have explored the link between heart disease and testosterone therapy.

"Until evidence from large, randomized trials becomes available, the Endocrine Society believes that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms. Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have preexisting heart disease," the statement said.

The Food and Drug Administration announced Jan. 31 that it has launched an investigation into the dangers of testosterone therapy in men with heart conditions, but the agency fell short of advising against the therapy altogether.

[email protected]

The Endocrine Society is calling for large-scale controlled trials of both testosterone therapy’s effects on older men and the association between testosterone therapy and cardiovascular disease.

The statement comes on the heels of an analysis published in PLoS One by Dr. William D. Finkle and his associates. They found a doubled risk of MIs in men under age 65 years who had preexisting heart conditions and were taking testosterone. In men over age 65 taking testosterone, the MI risk was even greater (PLoS ONE 2015 Jan. 29 [doi:10.1371/journal.pone.0085805]).

Several studies and retrospective analyses connected with the National Institutes of Health and the Veterans Health Care System have explored the link between heart disease and testosterone therapy.

"Until evidence from large, randomized trials becomes available, the Endocrine Society believes that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms. Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have preexisting heart disease," the statement said.

The Food and Drug Administration announced Jan. 31 that it has launched an investigation into the dangers of testosterone therapy in men with heart conditions, but the agency fell short of advising against the therapy altogether.

[email protected]

The Endocrine Society is calling for large-scale controlled trials of both testosterone therapy’s effects on older men and the association between testosterone therapy and cardiovascular disease.

The statement comes on the heels of an analysis published in PLoS One by Dr. William D. Finkle and his associates. They found a doubled risk of MIs in men under age 65 years who had preexisting heart conditions and were taking testosterone. In men over age 65 taking testosterone, the MI risk was even greater (PLoS ONE 2015 Jan. 29 [doi:10.1371/journal.pone.0085805]).

Several studies and retrospective analyses connected with the National Institutes of Health and the Veterans Health Care System have explored the link between heart disease and testosterone therapy.

"Until evidence from large, randomized trials becomes available, the Endocrine Society believes that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms. Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have preexisting heart disease," the statement said.

The Food and Drug Administration announced Jan. 31 that it has launched an investigation into the dangers of testosterone therapy in men with heart conditions, but the agency fell short of advising against the therapy altogether.

[email protected]

Total United States health care costs could be lowered by billions of dollars per year if evidence-based guidelines for follow-up patient visits are established, according to the authors of a commentary in the January issue of the American Journal of Managed Care.

In addition, new standards for follow-up visits would improve access and maximize the quality of the visits without compromising or restricting care, wrote Emilia Javorsky of the University of Massachusetts and her associates.

"Scheduling habits may be unnecessarily contributing to the problems of limited access, excessive utilization, and excessive costs, without improvement in health care outcomes," the authors wrote. "The same scientific rigor that guides therapeutic decision making should be used to optimize chronic disease management."

They searched the PubMed database for studies discussing evidence-based guidelines for follow-up intervals for the Top 5 chronic conditions – mental disorders, back problems, arthritis, chronic obstructive pulmonary disease/asthma, and hypertension – in 2010. Out of 330 studies, only 8 recommended evidence-based follow-up intervals.

To illustrate the point, Ms. Javorsky and her associates crunched the numbers for follow-up treatment of hypertension, with patient visits typically occurring every 6 months. Hypertension management accounted for $47.4 billion in 2008, with $13.0 billion coming from outpatient visits. If follow-up visits were extended from 6 to 7 months, the authors argued, there would be a 15% decrease in the number of visits in 1 year, with cost savings predicted to be nearly $682 million/year.

In addition, many patients with hypertension could see even more effective care with new standards, as recent studies have suggested that more time is needed to reflect accurate therapy-induced changes in blood pressure.

How do you determine the appropriate interval for follow-up visits? Please leave your comments below.

[email protected]

Total United States health care costs could be lowered by billions of dollars per year if evidence-based guidelines for follow-up patient visits are established, according to the authors of a commentary in the January issue of the American Journal of Managed Care.

In addition, new standards for follow-up visits would improve access and maximize the quality of the visits without compromising or restricting care, wrote Emilia Javorsky of the University of Massachusetts and her associates.

"Scheduling habits may be unnecessarily contributing to the problems of limited access, excessive utilization, and excessive costs, without improvement in health care outcomes," the authors wrote. "The same scientific rigor that guides therapeutic decision making should be used to optimize chronic disease management."

They searched the PubMed database for studies discussing evidence-based guidelines for follow-up intervals for the Top 5 chronic conditions – mental disorders, back problems, arthritis, chronic obstructive pulmonary disease/asthma, and hypertension – in 2010. Out of 330 studies, only 8 recommended evidence-based follow-up intervals.

To illustrate the point, Ms. Javorsky and her associates crunched the numbers for follow-up treatment of hypertension, with patient visits typically occurring every 6 months. Hypertension management accounted for $47.4 billion in 2008, with $13.0 billion coming from outpatient visits. If follow-up visits were extended from 6 to 7 months, the authors argued, there would be a 15% decrease in the number of visits in 1 year, with cost savings predicted to be nearly $682 million/year.

In addition, many patients with hypertension could see even more effective care with new standards, as recent studies have suggested that more time is needed to reflect accurate therapy-induced changes in blood pressure.

How do you determine the appropriate interval for follow-up visits? Please leave your comments below.

[email protected]

Total United States health care costs could be lowered by billions of dollars per year if evidence-based guidelines for follow-up patient visits are established, according to the authors of a commentary in the January issue of the American Journal of Managed Care.

In addition, new standards for follow-up visits would improve access and maximize the quality of the visits without compromising or restricting care, wrote Emilia Javorsky of the University of Massachusetts and her associates.

"Scheduling habits may be unnecessarily contributing to the problems of limited access, excessive utilization, and excessive costs, without improvement in health care outcomes," the authors wrote. "The same scientific rigor that guides therapeutic decision making should be used to optimize chronic disease management."

They searched the PubMed database for studies discussing evidence-based guidelines for follow-up intervals for the Top 5 chronic conditions – mental disorders, back problems, arthritis, chronic obstructive pulmonary disease/asthma, and hypertension – in 2010. Out of 330 studies, only 8 recommended evidence-based follow-up intervals.

To illustrate the point, Ms. Javorsky and her associates crunched the numbers for follow-up treatment of hypertension, with patient visits typically occurring every 6 months. Hypertension management accounted for $47.4 billion in 2008, with $13.0 billion coming from outpatient visits. If follow-up visits were extended from 6 to 7 months, the authors argued, there would be a 15% decrease in the number of visits in 1 year, with cost savings predicted to be nearly $682 million/year.

In addition, many patients with hypertension could see even more effective care with new standards, as recent studies have suggested that more time is needed to reflect accurate therapy-induced changes in blood pressure.

How do you determine the appropriate interval for follow-up visits? Please leave your comments below.

[email protected]

Exceeding the recommended dosage of over-the-counter sodium phosphate drugs can lead to severe kidney and heart problems, the Food and Drug Administration has announced.

The drugs, which are often prescribed for constipation relief, have been linked to dehydration, changes in electrolyte levels, and more severe complications, including kidney injury, arrhythmias, and death, the agency said in a statement.

A review of data from the FDA’s Adverse Event Reporting System and the medical literature identified 54 cases of adverse events from sodium phosphate drugs, with 25 adults and 29 children affected between 1957 and 2013. Of those cases, which included both rectal and oral administration of the drugs, adverse events deemed serious occurred in 60% (16) of the pediatric cases and 70% (16) of the adult cases, and resulted in the death of one child and twelve adults.

According to the reports, most cases of serious harm occurred with a single dose that was larger than recommended or with more than one dose per day. The recommended dosage is one dose per day for a maximum of 3 days.

While adverse effects are rare, the FDA recommends caution in prescribing the drugs. Young children, patients over 55 years, and people with a history of kidney problems are at an increased risk of potential adverse events.

[email protected]

Exceeding the recommended dosage of over-the-counter sodium phosphate drugs can lead to severe kidney and heart problems, the Food and Drug Administration has announced.

The drugs, which are often prescribed for constipation relief, have been linked to dehydration, changes in electrolyte levels, and more severe complications, including kidney injury, arrhythmias, and death, the agency said in a statement.

A review of data from the FDA’s Adverse Event Reporting System and the medical literature identified 54 cases of adverse events from sodium phosphate drugs, with 25 adults and 29 children affected between 1957 and 2013. Of those cases, which included both rectal and oral administration of the drugs, adverse events deemed serious occurred in 60% (16) of the pediatric cases and 70% (16) of the adult cases, and resulted in the death of one child and twelve adults.

According to the reports, most cases of serious harm occurred with a single dose that was larger than recommended or with more than one dose per day. The recommended dosage is one dose per day for a maximum of 3 days.

While adverse effects are rare, the FDA recommends caution in prescribing the drugs. Young children, patients over 55 years, and people with a history of kidney problems are at an increased risk of potential adverse events.

[email protected]

Exceeding the recommended dosage of over-the-counter sodium phosphate drugs can lead to severe kidney and heart problems, the Food and Drug Administration has announced.

The drugs, which are often prescribed for constipation relief, have been linked to dehydration, changes in electrolyte levels, and more severe complications, including kidney injury, arrhythmias, and death, the agency said in a statement.

A review of data from the FDA’s Adverse Event Reporting System and the medical literature identified 54 cases of adverse events from sodium phosphate drugs, with 25 adults and 29 children affected between 1957 and 2013. Of those cases, which included both rectal and oral administration of the drugs, adverse events deemed serious occurred in 60% (16) of the pediatric cases and 70% (16) of the adult cases, and resulted in the death of one child and twelve adults.

According to the reports, most cases of serious harm occurred with a single dose that was larger than recommended or with more than one dose per day. The recommended dosage is one dose per day for a maximum of 3 days.

While adverse effects are rare, the FDA recommends caution in prescribing the drugs. Young children, patients over 55 years, and people with a history of kidney problems are at an increased risk of potential adverse events.

[email protected]

A minimally invasive, ultrasound-guided biopsy technique safely harvested synovial tissue samples for immunohistochemical analysis and RNA extraction from both large and small joints of patients with inflammatory arthritis of less than 1 year duration in a small, single-center study.

Dr. Stephen Kelly of Mile End Hospital at Barts Health NHS Trust in London and his colleagues collected a median of 14 samples per procedure in 57 patients with a mean age of 50 years who were a part of the Pathobiology of Early Arthritis Cohort, a multicenter consortium that recruits patients in the early stages of arthritis. Clinical diagnoses in the patients included rheumatoid arthritis (40); psoriatic arthritis (6); undifferentiated arthritis (10); and monoarthritis (1). The investigators took tissue from the knee, elbow, and wrist, as well as metacarpal phalangeal and proximal interphalangeal joints (Ann. Rheum. Dis. 2013 Dec. 13 [doi:10.1136/annrheumdis-2013-204603]).

Synovial tissue biopsies are performed to collect RNA, identify tissue damage, and monitor early stages of rheumatoid arthritis and other joint disorders. The procedure is usually done using a blind needle examination – the simplest of biopsy options – or with arthroscopy, which the authors argue is a more complicated procedure and can target only larger joints (which is not a problem with the ultrasound-guided procedure). Although arthroscopy is still the ‘gold standard’ for joint tissue collection, the ability to conduct minimally invasive synovial tissue sampling would benefit research and drug development, as well as potentially assisting diagnosis, classification, and monitoring of treatment.

The investigators recorded no major complications and only mild pain or discomfort in 93 procedures in the patients, including 36 who participated in a follow-up procedure. In addition, 86 of the biopsies (93%) yielded high-quality tissue samples, on par with other ultrasound extraction methods like renal biopsies in which suitable tissue for analysis is obtained in 83%-97% of reported cases.

At a follow-up visit 3-7 days after the procedure, the patients did not have infection, hemarthrosis, deep venous thrombosis, thrombophlebitis, or flare of the underlying disease. A total of 18 patients reported mild arthralgia after the procedure, but this resolved within 24 hours with simple analgesia. Although 36 of the 57 patients initially agreed to a follow-up procedure at 6 months, an additional 18 patients also agreed after the database for this study’s analysis had been closed. These results lend additional validation to the good safety and tolerability findings from an initial proof of concept study in nine patients with established rheumatoid arthritis (Arthritis Res. Ther. 2007;9:R101).

The study was supported by a grant from the Medical Research Council, and Dr. Kelly reported receiving a Clinical Research Fellowship from Arthritis Research UK.

[email protected]

A minimally invasive, ultrasound-guided biopsy technique safely harvested synovial tissue samples for immunohistochemical analysis and RNA extraction from both large and small joints of patients with inflammatory arthritis of less than 1 year duration in a small, single-center study.

Dr. Stephen Kelly of Mile End Hospital at Barts Health NHS Trust in London and his colleagues collected a median of 14 samples per procedure in 57 patients with a mean age of 50 years who were a part of the Pathobiology of Early Arthritis Cohort, a multicenter consortium that recruits patients in the early stages of arthritis. Clinical diagnoses in the patients included rheumatoid arthritis (40); psoriatic arthritis (6); undifferentiated arthritis (10); and monoarthritis (1). The investigators took tissue from the knee, elbow, and wrist, as well as metacarpal phalangeal and proximal interphalangeal joints (Ann. Rheum. Dis. 2013 Dec. 13 [doi:10.1136/annrheumdis-2013-204603]).

Synovial tissue biopsies are performed to collect RNA, identify tissue damage, and monitor early stages of rheumatoid arthritis and other joint disorders. The procedure is usually done using a blind needle examination – the simplest of biopsy options – or with arthroscopy, which the authors argue is a more complicated procedure and can target only larger joints (which is not a problem with the ultrasound-guided procedure). Although arthroscopy is still the ‘gold standard’ for joint tissue collection, the ability to conduct minimally invasive synovial tissue sampling would benefit research and drug development, as well as potentially assisting diagnosis, classification, and monitoring of treatment.

The investigators recorded no major complications and only mild pain or discomfort in 93 procedures in the patients, including 36 who participated in a follow-up procedure. In addition, 86 of the biopsies (93%) yielded high-quality tissue samples, on par with other ultrasound extraction methods like renal biopsies in which suitable tissue for analysis is obtained in 83%-97% of reported cases.

At a follow-up visit 3-7 days after the procedure, the patients did not have infection, hemarthrosis, deep venous thrombosis, thrombophlebitis, or flare of the underlying disease. A total of 18 patients reported mild arthralgia after the procedure, but this resolved within 24 hours with simple analgesia. Although 36 of the 57 patients initially agreed to a follow-up procedure at 6 months, an additional 18 patients also agreed after the database for this study’s analysis had been closed. These results lend additional validation to the good safety and tolerability findings from an initial proof of concept study in nine patients with established rheumatoid arthritis (Arthritis Res. Ther. 2007;9:R101).

The study was supported by a grant from the Medical Research Council, and Dr. Kelly reported receiving a Clinical Research Fellowship from Arthritis Research UK.

[email protected]

A minimally invasive, ultrasound-guided biopsy technique safely harvested synovial tissue samples for immunohistochemical analysis and RNA extraction from both large and small joints of patients with inflammatory arthritis of less than 1 year duration in a small, single-center study.

Dr. Stephen Kelly of Mile End Hospital at Barts Health NHS Trust in London and his colleagues collected a median of 14 samples per procedure in 57 patients with a mean age of 50 years who were a part of the Pathobiology of Early Arthritis Cohort, a multicenter consortium that recruits patients in the early stages of arthritis. Clinical diagnoses in the patients included rheumatoid arthritis (40); psoriatic arthritis (6); undifferentiated arthritis (10); and monoarthritis (1). The investigators took tissue from the knee, elbow, and wrist, as well as metacarpal phalangeal and proximal interphalangeal joints (Ann. Rheum. Dis. 2013 Dec. 13 [doi:10.1136/annrheumdis-2013-204603]).

Synovial tissue biopsies are performed to collect RNA, identify tissue damage, and monitor early stages of rheumatoid arthritis and other joint disorders. The procedure is usually done using a blind needle examination – the simplest of biopsy options – or with arthroscopy, which the authors argue is a more complicated procedure and can target only larger joints (which is not a problem with the ultrasound-guided procedure). Although arthroscopy is still the ‘gold standard’ for joint tissue collection, the ability to conduct minimally invasive synovial tissue sampling would benefit research and drug development, as well as potentially assisting diagnosis, classification, and monitoring of treatment.

The investigators recorded no major complications and only mild pain or discomfort in 93 procedures in the patients, including 36 who participated in a follow-up procedure. In addition, 86 of the biopsies (93%) yielded high-quality tissue samples, on par with other ultrasound extraction methods like renal biopsies in which suitable tissue for analysis is obtained in 83%-97% of reported cases.

At a follow-up visit 3-7 days after the procedure, the patients did not have infection, hemarthrosis, deep venous thrombosis, thrombophlebitis, or flare of the underlying disease. A total of 18 patients reported mild arthralgia after the procedure, but this resolved within 24 hours with simple analgesia. Although 36 of the 57 patients initially agreed to a follow-up procedure at 6 months, an additional 18 patients also agreed after the database for this study’s analysis had been closed. These results lend additional validation to the good safety and tolerability findings from an initial proof of concept study in nine patients with established rheumatoid arthritis (Arthritis Res. Ther. 2007;9:R101).

The study was supported by a grant from the Medical Research Council, and Dr. Kelly reported receiving a Clinical Research Fellowship from Arthritis Research UK.

[email protected]

Although the United States deserves recognition for sustaining elimination of measles, rubella, and congenital rubella syndrome, importation of the diseases remains a threat, according to research published Dec. 5 in JAMA Pediatrics.

The study, designed to review the evidence for sustained elimination of endemic measles, rubella, and congenital rubella syndrome (CRS), was submitted to the Pan American Health Organization as a way to review the evidence for prevention of the diseases. Measles was declared eliminated from the United States in 2000, and endemic rubella and CRS were eliminated from the United States in 2004.

CDC/Dr. Heinz F. Eichenwald

"Collectively, the very low disease incidences, the high proportions of importation-associated cases, the absence of endemic genotypes, the adequate surveillance, and the high levels of population immunity all indicate that the elimination of endemic measles, rubella, and CRS has been sustained in the United States," reported Dr. Mark J. Papania of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention and his associates. "However, because measles and rubella remain endemic in many parts of the world, importations will continue to occur."

There has been significant global progress in the past 10 years in reducing measles deaths in children, and recent advances in elimination of the disease have been "tremendous but unfinished," Dr. Thomas Frieden, director of the CDC, said at a press conference. He pointed to two small spikes in measles cases in 2011 and 2013, but stressed that less than 2% of the patients in those cases were fully vaccinated. "It is not a failure of the vaccine, it is a failure to vaccinate," he said.

Dr. Samuel L. Katz, chair emeritus of pediatrics at Duke University in Durham, N.C., and coinventor of measles vaccine, highlighted the work of local administrators and health professionals in the field as a major factor in reducing measles deaths around the world. "It’s been 50 years [since the vaccine was invented], and we’re pretty much using the same vaccine in the same way," he said at the press conference, but he mentioned a number of potential improvements to the vaccine currently in development, including microneedles and aerosol sprays.

Courtesy CDC

Dr. Papania and his associates reviewed state health department data submitted to the CDC, as well as data on vaccine exemption and measles and rubella seroprevalence from the National Health and Nutrition Examination Survey. Measles-mumps-rubella (MMR) vaccine coverage data were obtained from the National Immunization Survey, the National Immunization Survey–Teen, and kindergarten immunization surveys conducted by the states (JAMA Pediatr. 2013 Dec. 5 [doi: 10.1001/jamapediatrics.2013.4342]).

There were 911 cases of measles reported between 2001 and 2011, which falls below the elimination criterion of 1 case per 1,000,000 per year. Of those reported measles cases, 801 (88%) were import-associated, the investigators wrote. Sixty-five percent of measles cases were unvaccinated, and 20% had unknown vaccination status.

Rubella and CRS were even rarer, with 77 rubella cases and 4 CRS cases reported between 2004 and 2011. Forty-two rubella cases (54%) were determined to be import-associated, and 88% of patients with the disease were unvaccinated or of unknown vaccination status. The average yearly reported CRS incidence was less than 1 case per 5,000,000 births. Three cases were import-associated, with maternal exposures to rubella occurring outside the United States.

The keys to sustaining elimination of the diseases in the western hemisphere will be sustaining high levels of immunity throughout the U.S. population through vaccination, maintaining strong U.S. surveillance and public health response capacity, and supporting other countries in their efforts, Dr. Papania and his associates concluded.

The investigators also noted that elimination of the diseases in the United States does not necessarily mean extinction, because most U.S. cases of the diseases were traced to other parts of the world or locally transmitted.

The CDC spent approximately $438.9 million from 2001 to 2011 on global measles control activities, the authors wrote, including purchasing more than 200 million doses of the measles vaccine.

No conflict of interest disclosures were reported.

[email protected]

Although the United States deserves recognition for sustaining elimination of measles, rubella, and congenital rubella syndrome, importation of the diseases remains a threat, according to research published Dec. 5 in JAMA Pediatrics.

The study, designed to review the evidence for sustained elimination of endemic measles, rubella, and congenital rubella syndrome (CRS), was submitted to the Pan American Health Organization as a way to review the evidence for prevention of the diseases. Measles was declared eliminated from the United States in 2000, and endemic rubella and CRS were eliminated from the United States in 2004.

CDC/Dr. Heinz F. Eichenwald

"Collectively, the very low disease incidences, the high proportions of importation-associated cases, the absence of endemic genotypes, the adequate surveillance, and the high levels of population immunity all indicate that the elimination of endemic measles, rubella, and CRS has been sustained in the United States," reported Dr. Mark J. Papania of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention and his associates. "However, because measles and rubella remain endemic in many parts of the world, importations will continue to occur."

There has been significant global progress in the past 10 years in reducing measles deaths in children, and recent advances in elimination of the disease have been "tremendous but unfinished," Dr. Thomas Frieden, director of the CDC, said at a press conference. He pointed to two small spikes in measles cases in 2011 and 2013, but stressed that less than 2% of the patients in those cases were fully vaccinated. "It is not a failure of the vaccine, it is a failure to vaccinate," he said.

Dr. Samuel L. Katz, chair emeritus of pediatrics at Duke University in Durham, N.C., and coinventor of measles vaccine, highlighted the work of local administrators and health professionals in the field as a major factor in reducing measles deaths around the world. "It’s been 50 years [since the vaccine was invented], and we’re pretty much using the same vaccine in the same way," he said at the press conference, but he mentioned a number of potential improvements to the vaccine currently in development, including microneedles and aerosol sprays.

Courtesy CDC

Dr. Papania and his associates reviewed state health department data submitted to the CDC, as well as data on vaccine exemption and measles and rubella seroprevalence from the National Health and Nutrition Examination Survey. Measles-mumps-rubella (MMR) vaccine coverage data were obtained from the National Immunization Survey, the National Immunization Survey–Teen, and kindergarten immunization surveys conducted by the states (JAMA Pediatr. 2013 Dec. 5 [doi: 10.1001/jamapediatrics.2013.4342]).

There were 911 cases of measles reported between 2001 and 2011, which falls below the elimination criterion of 1 case per 1,000,000 per year. Of those reported measles cases, 801 (88%) were import-associated, the investigators wrote. Sixty-five percent of measles cases were unvaccinated, and 20% had unknown vaccination status.

Rubella and CRS were even rarer, with 77 rubella cases and 4 CRS cases reported between 2004 and 2011. Forty-two rubella cases (54%) were determined to be import-associated, and 88% of patients with the disease were unvaccinated or of unknown vaccination status. The average yearly reported CRS incidence was less than 1 case per 5,000,000 births. Three cases were import-associated, with maternal exposures to rubella occurring outside the United States.

The keys to sustaining elimination of the diseases in the western hemisphere will be sustaining high levels of immunity throughout the U.S. population through vaccination, maintaining strong U.S. surveillance and public health response capacity, and supporting other countries in their efforts, Dr. Papania and his associates concluded.

The investigators also noted that elimination of the diseases in the United States does not necessarily mean extinction, because most U.S. cases of the diseases were traced to other parts of the world or locally transmitted.

The CDC spent approximately $438.9 million from 2001 to 2011 on global measles control activities, the authors wrote, including purchasing more than 200 million doses of the measles vaccine.

No conflict of interest disclosures were reported.

[email protected]

Although the United States deserves recognition for sustaining elimination of measles, rubella, and congenital rubella syndrome, importation of the diseases remains a threat, according to research published Dec. 5 in JAMA Pediatrics.

The study, designed to review the evidence for sustained elimination of endemic measles, rubella, and congenital rubella syndrome (CRS), was submitted to the Pan American Health Organization as a way to review the evidence for prevention of the diseases. Measles was declared eliminated from the United States in 2000, and endemic rubella and CRS were eliminated from the United States in 2004.

CDC/Dr. Heinz F. Eichenwald

"Collectively, the very low disease incidences, the high proportions of importation-associated cases, the absence of endemic genotypes, the adequate surveillance, and the high levels of population immunity all indicate that the elimination of endemic measles, rubella, and CRS has been sustained in the United States," reported Dr. Mark J. Papania of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention and his associates. "However, because measles and rubella remain endemic in many parts of the world, importations will continue to occur."

There has been significant global progress in the past 10 years in reducing measles deaths in children, and recent advances in elimination of the disease have been "tremendous but unfinished," Dr. Thomas Frieden, director of the CDC, said at a press conference. He pointed to two small spikes in measles cases in 2011 and 2013, but stressed that less than 2% of the patients in those cases were fully vaccinated. "It is not a failure of the vaccine, it is a failure to vaccinate," he said.

Dr. Samuel L. Katz, chair emeritus of pediatrics at Duke University in Durham, N.C., and coinventor of measles vaccine, highlighted the work of local administrators and health professionals in the field as a major factor in reducing measles deaths around the world. "It’s been 50 years [since the vaccine was invented], and we’re pretty much using the same vaccine in the same way," he said at the press conference, but he mentioned a number of potential improvements to the vaccine currently in development, including microneedles and aerosol sprays.

Courtesy CDC

Dr. Papania and his associates reviewed state health department data submitted to the CDC, as well as data on vaccine exemption and measles and rubella seroprevalence from the National Health and Nutrition Examination Survey. Measles-mumps-rubella (MMR) vaccine coverage data were obtained from the National Immunization Survey, the National Immunization Survey–Teen, and kindergarten immunization surveys conducted by the states (JAMA Pediatr. 2013 Dec. 5 [doi: 10.1001/jamapediatrics.2013.4342]).

There were 911 cases of measles reported between 2001 and 2011, which falls below the elimination criterion of 1 case per 1,000,000 per year. Of those reported measles cases, 801 (88%) were import-associated, the investigators wrote. Sixty-five percent of measles cases were unvaccinated, and 20% had unknown vaccination status.

Rubella and CRS were even rarer, with 77 rubella cases and 4 CRS cases reported between 2004 and 2011. Forty-two rubella cases (54%) were determined to be import-associated, and 88% of patients with the disease were unvaccinated or of unknown vaccination status. The average yearly reported CRS incidence was less than 1 case per 5,000,000 births. Three cases were import-associated, with maternal exposures to rubella occurring outside the United States.

The keys to sustaining elimination of the diseases in the western hemisphere will be sustaining high levels of immunity throughout the U.S. population through vaccination, maintaining strong U.S. surveillance and public health response capacity, and supporting other countries in their efforts, Dr. Papania and his associates concluded.

The investigators also noted that elimination of the diseases in the United States does not necessarily mean extinction, because most U.S. cases of the diseases were traced to other parts of the world or locally transmitted.

The CDC spent approximately $438.9 million from 2001 to 2011 on global measles control activities, the authors wrote, including purchasing more than 200 million doses of the measles vaccine.

No conflict of interest disclosures were reported.

[email protected]

Johns Hopkins Hospital’s black lung x-ray program has been suspended following an investigation by the Center for Public Integrity and ABC News.

The investigation, published on the center’s web site, alleges that Dr. Paul Wheeler, a radiologist from Johns Hopkins, reviewed more than 1,500 x-rays of coal miners’ lungs since 2000 and never found a single instance of black lung, which would automatically qualify the miner for disability benefits under a federal program. The report states that Dr. Wheeler’s findings are being used by the coal industry to refute claims of black lung and ultimately deny monthly benefit payments to the patients. The center’s investigation documented that black lung patients have lost more than 800 cases after at least one other physician had found evidence of the disease on an x-ray that Dr. Wheeler read as negative. In addition, the report notes that the black lung unit at Hopkins receives funding from coal mining companies to perform the examinations. Physicians do not receive any financial incentives for participating in the black lung program, according to a statement on the Hopkins website.

As a result of the study, officials from the United Mine Workers of America union are calling for Dr. Wheeler to be prohibited from performing any x-ray readings related to the disease.

"We take very seriously the questions raised in a recent ABC News report about our second opinions for pneumoconiosis including black lung disease, and we are carefully reviewing the news story and our pneumoconiosis service," Hopkins said in the statement.

Read the full investigative report here.

[email protected]

Johns Hopkins Hospital’s black lung x-ray program has been suspended following an investigation by the Center for Public Integrity and ABC News.

The investigation, published on the center’s web site, alleges that Dr. Paul Wheeler, a radiologist from Johns Hopkins, reviewed more than 1,500 x-rays of coal miners’ lungs since 2000 and never found a single instance of black lung, which would automatically qualify the miner for disability benefits under a federal program. The report states that Dr. Wheeler’s findings are being used by the coal industry to refute claims of black lung and ultimately deny monthly benefit payments to the patients. The center’s investigation documented that black lung patients have lost more than 800 cases after at least one other physician had found evidence of the disease on an x-ray that Dr. Wheeler read as negative. In addition, the report notes that the black lung unit at Hopkins receives funding from coal mining companies to perform the examinations. Physicians do not receive any financial incentives for participating in the black lung program, according to a statement on the Hopkins website.

As a result of the study, officials from the United Mine Workers of America union are calling for Dr. Wheeler to be prohibited from performing any x-ray readings related to the disease.

"We take very seriously the questions raised in a recent ABC News report about our second opinions for pneumoconiosis including black lung disease, and we are carefully reviewing the news story and our pneumoconiosis service," Hopkins said in the statement.

Read the full investigative report here.

[email protected]

Johns Hopkins Hospital’s black lung x-ray program has been suspended following an investigation by the Center for Public Integrity and ABC News.

The investigation, published on the center’s web site, alleges that Dr. Paul Wheeler, a radiologist from Johns Hopkins, reviewed more than 1,500 x-rays of coal miners’ lungs since 2000 and never found a single instance of black lung, which would automatically qualify the miner for disability benefits under a federal program. The report states that Dr. Wheeler’s findings are being used by the coal industry to refute claims of black lung and ultimately deny monthly benefit payments to the patients. The center’s investigation documented that black lung patients have lost more than 800 cases after at least one other physician had found evidence of the disease on an x-ray that Dr. Wheeler read as negative. In addition, the report notes that the black lung unit at Hopkins receives funding from coal mining companies to perform the examinations. Physicians do not receive any financial incentives for participating in the black lung program, according to a statement on the Hopkins website.

As a result of the study, officials from the United Mine Workers of America union are calling for Dr. Wheeler to be prohibited from performing any x-ray readings related to the disease.

"We take very seriously the questions raised in a recent ABC News report about our second opinions for pneumoconiosis including black lung disease, and we are carefully reviewing the news story and our pneumoconiosis service," Hopkins said in the statement.

Read the full investigative report here.

[email protected]

The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

[email protected]

The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

[email protected]

The Food and Drug Administration announced on Oct. 31 two initiatives aimed at cutting down on drug shortages and improving communications with drug companies.

The first is a proposed rule to require drug manufacturers to alert the FDA if certain "medically important drug products" are running low, Dr. Margaret Hamburg, commissioner of the agency, said during a teleconference announcing the initiatives. This proposal expands on early notification requirements included in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which created a task force designated to deal with drug shortages. The proposal also would extend those requirements to biologically manufactured drugs.

The second initiative is a strategic plan to improve communications between the FDA and drug manufacturers, develop short- and long-term contingency plans for drug shortages, and revamp communications processes within the agency to improve response times to potential shortages.

The strategy was developed with both internal and external input and analysis from work groups, drug manufacturers, and health care organizations. For the plan to work "this has to be a group effort," Dr. Hamburg said.

Drug shortages have declined significantly since 2012, with 117 drug shortages in 2012, down from 212 in 2011. But early notification from manufacturers about possible shortages can help drive those numbers down even further, said FDA representatives.

The strategic plan, which was required by FDASIA and is being sent to Congress Oct. 31, also includes new ideas such as the development of a smartphone app for real-time drug shortage news, a proposal for rewarding drug manufacturers based on cooperation with the FDA, and a new office within the Center for Drug Evaluation and Research focused exclusively on pharmaceutical quality.

Members of the public may comment on the proposed rule, which is scheduled to be published in the Federal Register on Nov. 4.

[email protected]

The Endocrine Society and the American Association of Clinical Endocrinologists have released a series of recommendations that advise against unnecessary tests and procedures in patient diagnosis and treatment.

More than 30 health organizations have released or will release treatment guidelines as part of the American Board of Internal Medicine Foundation’s "Choosing Wisely" campaign, which is meant to educate patients and physicians about unnecessary and potentially harmful testing and treatment. The recommendation lists, expected to be completed by early 2014, are part of a series that hopes to "spark conversations between patients and physicians about what care is really necessary for specific conditions."

The Endocrine Society and AACE recommended the following:

• Avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes on agents that do not cause hypoglycemia. Such testing can be excessive for patients who are doing a good job of maintaining glycemic control, and testing results can become quite predictable. There are a number of exceptions, such as when a patient is sick or losing weight, or when new medications are added or hemoglobin A_1c values stray from targets.

• Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function. In vitamin D deficiency, 1,25-dihydroxyvitamin D levels go up, not down. Serum levels of 1,25-dihyroxyvitamin D are regulated primarily by parathyroid hormone levels and have little connection to vitamin D stores. When trying to assess vitamin D stores or diagnose vitamin D deficiency (or toxicity), 25-hydroxyvitamin D is the correct test.

• Don’t routinely order a thyroid ultrasound in patients with abnormal thyroid function tests if there is no palpable abnormality of the thyroid gland. Nodules detected via ultrasound are usually unrelated to the abnormal thyroid function and may divert the clinical evaluation to assess the nodules, rather than the thyroid dysfunction.

• Don’t order a total or free T3 level when assessing levothyroxine (T4) dose in hypothyroid patients, as the blood level of total or free T3 may be misleading. With most patients, a normal TSH indicates a correct dose of T4.

• Don’t prescribe testosterone therapy unless there is strong biochemical evidence of testosterone deficiency. Many of the symptoms attributed to male hypogonadism are common in the normal male aging process or are the result of a comorbid condition. In addition, testosterone therapy is expensive and has the potential for serious side effects in some patients. Total testosterone levels should be taken in the morning, and a low level should be confirmed on a different day.

[email protected]

The Endocrine Society and the American Association of Clinical Endocrinologists have released a series of recommendations that advise against unnecessary tests and procedures in patient diagnosis and treatment.

More than 30 health organizations have released or will release treatment guidelines as part of the American Board of Internal Medicine Foundation’s "Choosing Wisely" campaign, which is meant to educate patients and physicians about unnecessary and potentially harmful testing and treatment. The recommendation lists, expected to be completed by early 2014, are part of a series that hopes to "spark conversations between patients and physicians about what care is really necessary for specific conditions."

The Endocrine Society and AACE recommended the following:

• Avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes on agents that do not cause hypoglycemia. Such testing can be excessive for patients who are doing a good job of maintaining glycemic control, and testing results can become quite predictable. There are a number of exceptions, such as when a patient is sick or losing weight, or when new medications are added or hemoglobin A_1c values stray from targets.

• Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function. In vitamin D deficiency, 1,25-dihydroxyvitamin D levels go up, not down. Serum levels of 1,25-dihyroxyvitamin D are regulated primarily by parathyroid hormone levels and have little connection to vitamin D stores. When trying to assess vitamin D stores or diagnose vitamin D deficiency (or toxicity), 25-hydroxyvitamin D is the correct test.

• Don’t routinely order a thyroid ultrasound in patients with abnormal thyroid function tests if there is no palpable abnormality of the thyroid gland. Nodules detected via ultrasound are usually unrelated to the abnormal thyroid function and may divert the clinical evaluation to assess the nodules, rather than the thyroid dysfunction.

• Don’t order a total or free T3 level when assessing levothyroxine (T4) dose in hypothyroid patients, as the blood level of total or free T3 may be misleading. With most patients, a normal TSH indicates a correct dose of T4.

• Don’t prescribe testosterone therapy unless there is strong biochemical evidence of testosterone deficiency. Many of the symptoms attributed to male hypogonadism are common in the normal male aging process or are the result of a comorbid condition. In addition, testosterone therapy is expensive and has the potential for serious side effects in some patients. Total testosterone levels should be taken in the morning, and a low level should be confirmed on a different day.

[email protected]

The Endocrine Society and the American Association of Clinical Endocrinologists have released a series of recommendations that advise against unnecessary tests and procedures in patient diagnosis and treatment.

More than 30 health organizations have released or will release treatment guidelines as part of the American Board of Internal Medicine Foundation’s "Choosing Wisely" campaign, which is meant to educate patients and physicians about unnecessary and potentially harmful testing and treatment. The recommendation lists, expected to be completed by early 2014, are part of a series that hopes to "spark conversations between patients and physicians about what care is really necessary for specific conditions."

The Endocrine Society and AACE recommended the following:

• Avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes on agents that do not cause hypoglycemia. Such testing can be excessive for patients who are doing a good job of maintaining glycemic control, and testing results can become quite predictable. There are a number of exceptions, such as when a patient is sick or losing weight, or when new medications are added or hemoglobin A_1c values stray from targets.

• Don’t routinely measure 1,25-dihydroxyvitamin D unless the patient has hypercalcemia or decreased kidney function. In vitamin D deficiency, 1,25-dihydroxyvitamin D levels go up, not down. Serum levels of 1,25-dihyroxyvitamin D are regulated primarily by parathyroid hormone levels and have little connection to vitamin D stores. When trying to assess vitamin D stores or diagnose vitamin D deficiency (or toxicity), 25-hydroxyvitamin D is the correct test.

• Don’t routinely order a thyroid ultrasound in patients with abnormal thyroid function tests if there is no palpable abnormality of the thyroid gland. Nodules detected via ultrasound are usually unrelated to the abnormal thyroid function and may divert the clinical evaluation to assess the nodules, rather than the thyroid dysfunction.

• Don’t order a total or free T3 level when assessing levothyroxine (T4) dose in hypothyroid patients, as the blood level of total or free T3 may be misleading. With most patients, a normal TSH indicates a correct dose of T4.

• Don’t prescribe testosterone therapy unless there is strong biochemical evidence of testosterone deficiency. Many of the symptoms attributed to male hypogonadism are common in the normal male aging process or are the result of a comorbid condition. In addition, testosterone therapy is expensive and has the potential for serious side effects in some patients. Total testosterone levels should be taken in the morning, and a low level should be confirmed on a different day.

[email protected]