A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

A version of this article first appeared on WebMD.com.

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

A version of this article first appeared on WebMD.com.

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

A version of this article first appeared on WebMD.com.

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

A version of this article first appeared on Medscape.com.

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.

A Canadian woman was recently charged by police in Vancouver, British Columbia, with impersonating a registered nurse while working inside a local hospital. Online news reports indicate the suspect has a long history of similar deception in other locations in Canada and the United States dating back 30 years.

The Vancouver Police Department (VPD) charged the woman, who goes by the name of Brigitte Cleroux, 49, with fraud over $5,000 and personation with intent. VPD launched an investigation in June after learning that an employee at BC Women’s Hospital had fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release. At press time, Ms. Cleroux was in custody, and her next court appearance was set for Jan. 5, according to BC court records.

In June, the British Columbia College of Nurses & Midwives (BCCNM) issued a warning that Ms. Cleroux might be using aliases, including Melanie Smith. It stated that it had “received a report that Melanie Smith has held herself out as a registered nurse in British Columbia in order to seek employment in a hospital, dental surgery clinic, and in residential care.” The aliases included Melanie Thompson and Melanie Cleroux.

“This person has never been and is not a registrant of BCCNM and is not entitled to practice as a registered nurse in British Columbia.”

“Our detectives worked collaboratively with the Ottawa Police Service, which was conducting a parallel investigation into the same suspect,” said Constable Tania Visintin. “We don’t yet know how many people in Vancouver may have received treatment from the fraudulent nurse, but we’re working with the Provincial Health Services Authority to identify patients who may have had contact with her.”

Ottawa Police had charged Ms. Cleroux in September with more serious offenses of assault with a weapon and criminal negligence causing bodily harm along with “personation to gain advantage,” obtaining by false pretense, and using a forged document.

The charges followed an investigation into “personation, criminal negligence and fraud-related incidents after falsely gaining employment and conducting duties as a nurse at a medical and dental clinic in Ottawa. Some of those duties included the administration of medications, including injections, to patients,” police said in a statement.

“The investigation began when police were told that a woman had used aliases and assumed the identifies of registered nurses that she fraudulently obtained.” Police said they believed there might be other clinics and victims.

The College of Nurses of Ontario also issued a warning about Ms. Cleroux and a list of seven other aliases under the Ottawa region heading.

Ms. Cleroux’s past includes reports of a long string of deception dating back about three decades and including incidents in Florida and Colorado. Ms. Cleroux was in nursing school in Colorado but only competed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC Radio-Canada.

A version of this article first appeared on Medscape.com.

A Canadian woman was recently charged by police in Vancouver, British Columbia, with impersonating a registered nurse while working inside a local hospital. Online news reports indicate the suspect has a long history of similar deception in other locations in Canada and the United States dating back 30 years.

The Vancouver Police Department (VPD) charged the woman, who goes by the name of Brigitte Cleroux, 49, with fraud over $5,000 and personation with intent. VPD launched an investigation in June after learning that an employee at BC Women’s Hospital had fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release. At press time, Ms. Cleroux was in custody, and her next court appearance was set for Jan. 5, according to BC court records.

In June, the British Columbia College of Nurses & Midwives (BCCNM) issued a warning that Ms. Cleroux might be using aliases, including Melanie Smith. It stated that it had “received a report that Melanie Smith has held herself out as a registered nurse in British Columbia in order to seek employment in a hospital, dental surgery clinic, and in residential care.” The aliases included Melanie Thompson and Melanie Cleroux.

“This person has never been and is not a registrant of BCCNM and is not entitled to practice as a registered nurse in British Columbia.”

“Our detectives worked collaboratively with the Ottawa Police Service, which was conducting a parallel investigation into the same suspect,” said Constable Tania Visintin. “We don’t yet know how many people in Vancouver may have received treatment from the fraudulent nurse, but we’re working with the Provincial Health Services Authority to identify patients who may have had contact with her.”

Ottawa Police had charged Ms. Cleroux in September with more serious offenses of assault with a weapon and criminal negligence causing bodily harm along with “personation to gain advantage,” obtaining by false pretense, and using a forged document.

The charges followed an investigation into “personation, criminal negligence and fraud-related incidents after falsely gaining employment and conducting duties as a nurse at a medical and dental clinic in Ottawa. Some of those duties included the administration of medications, including injections, to patients,” police said in a statement.

“The investigation began when police were told that a woman had used aliases and assumed the identifies of registered nurses that she fraudulently obtained.” Police said they believed there might be other clinics and victims.

The College of Nurses of Ontario also issued a warning about Ms. Cleroux and a list of seven other aliases under the Ottawa region heading.

Ms. Cleroux’s past includes reports of a long string of deception dating back about three decades and including incidents in Florida and Colorado. Ms. Cleroux was in nursing school in Colorado but only competed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC Radio-Canada.

A version of this article first appeared on Medscape.com.

A Canadian woman was recently charged by police in Vancouver, British Columbia, with impersonating a registered nurse while working inside a local hospital. Online news reports indicate the suspect has a long history of similar deception in other locations in Canada and the United States dating back 30 years.

The Vancouver Police Department (VPD) charged the woman, who goes by the name of Brigitte Cleroux, 49, with fraud over $5,000 and personation with intent. VPD launched an investigation in June after learning that an employee at BC Women’s Hospital had fraudulently identified herself as a nurse while working there between June 2020 and June 2021, according to a VPD press release. At press time, Ms. Cleroux was in custody, and her next court appearance was set for Jan. 5, according to BC court records.

In June, the British Columbia College of Nurses & Midwives (BCCNM) issued a warning that Ms. Cleroux might be using aliases, including Melanie Smith. It stated that it had “received a report that Melanie Smith has held herself out as a registered nurse in British Columbia in order to seek employment in a hospital, dental surgery clinic, and in residential care.” The aliases included Melanie Thompson and Melanie Cleroux.

“This person has never been and is not a registrant of BCCNM and is not entitled to practice as a registered nurse in British Columbia.”

“Our detectives worked collaboratively with the Ottawa Police Service, which was conducting a parallel investigation into the same suspect,” said Constable Tania Visintin. “We don’t yet know how many people in Vancouver may have received treatment from the fraudulent nurse, but we’re working with the Provincial Health Services Authority to identify patients who may have had contact with her.”

Ottawa Police had charged Ms. Cleroux in September with more serious offenses of assault with a weapon and criminal negligence causing bodily harm along with “personation to gain advantage,” obtaining by false pretense, and using a forged document.

The charges followed an investigation into “personation, criminal negligence and fraud-related incidents after falsely gaining employment and conducting duties as a nurse at a medical and dental clinic in Ottawa. Some of those duties included the administration of medications, including injections, to patients,” police said in a statement.

“The investigation began when police were told that a woman had used aliases and assumed the identifies of registered nurses that she fraudulently obtained.” Police said they believed there might be other clinics and victims.

The College of Nurses of Ontario also issued a warning about Ms. Cleroux and a list of seven other aliases under the Ottawa region heading.

Ms. Cleroux’s past includes reports of a long string of deception dating back about three decades and including incidents in Florida and Colorado. Ms. Cleroux was in nursing school in Colorado but only competed 2 years of a 4-year nursing course and was never certified as a nurse, according to CBC Radio-Canada.

A version of this article first appeared on Medscape.com.

Which vaccines are contraindicated in pregnancy?

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Which vaccines are contraindicated in pregnancy?

Continue to the answer...

Which vaccines are contraindicated in pregnancy?

Continue to the answer...

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

A version of this article first appeared on Medscape.com.

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

A version of this article first appeared on Medscape.com.

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

A version of this article first appeared on Medscape.com.

A growing number of patients with opioid use disorder (OUD) have a diagnosis of comorbid attention-deficit/hyperactivity disorder (ADHD), raising issues about whether it’s appropriate to prescribe stimulants in this patient population.

One new study showed that from 2007-2017, there was a threefold increase in OUD and comorbid ADHD and that a significant number of these patients received prescription stimulants.

“This is the beginning stages of looking at whether or not there are risks of prescribing stimulants to patients who are on medications for opioid use disorder,” investigator Tae Woo (Ted) Park, MD, assistant professor, department of psychiatry, University of Pittsburgh School of Medicine, told this news organization.

“More and more people are being identified with ADHD, and we need to do more research on the best way to manage this patient group,” Dr. Park added.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Biological connection?

Dr. Park is not convinced there is “an actual biological connection” between ADHD and OUD, noting that there are many reasons why patients with ADHD may be more prone to developing such a disorder.

Perhaps they did not get an ADHD diagnosis as a child, “which led to impairment in their ability to be successful at school and then in a job,” which in turn predisposed them to having a substance use disorder, said Dr. Park.

From previous research and his own clinical experience, ADHD can significantly affect quality of life and “cause increased impairment” in patients with a substance use disorder, he added.

Interestingly, there’s evidence suggesting patients treated for ADHD early in life are less likely to develop a substance use disorder later on, he said.

The “gold standard” treatment for ADHD is a prescription stimulant, which carries its own addiction risks. “So the issue is about whether or not to prescribe risky medications and how to weigh the risks and benefits,” said Dr. Park.

From a private health insurance database, researchers examined records for patients aged 18-64 years who were receiving medication for OUD, including buprenorphine, methadone, or naltrexone, from 2007-2017.

In the study sample, about 17,000 individuals were receiving stimulants, and 156,000 were not receiving these drugs. The largest percentage of participants in both groups was in the age-18-to-25 category.

About 35% of those receiving stimulants had ADHD, and about the same percentage had a mood disorder diagnosis.

Percentage of co-occurring ADHD and OUD increased from more than 4% in 2007 to more than 14% in 2017. The prevalence of stimulant use plus medication for OUD also increased during that time.

The increase in ADHD diagnoses may reflect growing identification of the condition, Dr. Park noted. As the opioid problem became more apparent and additional treatments made available, “there were more health care contacts, more assessments, and more diagnoses, including of ADHD,” he said.
 

Risks versus benefits

Stimulants may also be risky in patients with OUD. Results from another study presented at the AAAP meeting showed these drugs were associated with an increased chance of poisoning in patients receiving buprenorphine.

However, Dr. Park is skeptical the combination of stimulants and buprenorphine “leads to a biological risk of overdose.” He used a hypothetical scenario where other factors play into the connection: A patient gets a prescription stimulant, becomes addicted, then starts using street or illicit stimulants, which leads to a relapse on opioids, and then to an overdose.

Dr. Park noted that the same study that found an increased poisoning risk in stimulant users also found that patients tend to stay on buprenorphine treatment, providing protection against overdose.

“So there are risks and benefits of prescribing these medications, and it becomes tricky to know whether to prescribe them or not,” he said.

While stimulants are by far the best treatment for ADHD, atomoxetine (Strattera), a nonstimulant medication with antidepressant effects is another option, Dr. Park said.

He added that a limitation of his study was that very few individuals in the database received methadone.

A version of this article first appeared on Medscape.com.

A growing number of patients with opioid use disorder (OUD) have a diagnosis of comorbid attention-deficit/hyperactivity disorder (ADHD), raising issues about whether it’s appropriate to prescribe stimulants in this patient population.

One new study showed that from 2007-2017, there was a threefold increase in OUD and comorbid ADHD and that a significant number of these patients received prescription stimulants.

“This is the beginning stages of looking at whether or not there are risks of prescribing stimulants to patients who are on medications for opioid use disorder,” investigator Tae Woo (Ted) Park, MD, assistant professor, department of psychiatry, University of Pittsburgh School of Medicine, told this news organization.

“More and more people are being identified with ADHD, and we need to do more research on the best way to manage this patient group,” Dr. Park added.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Biological connection?

Dr. Park is not convinced there is “an actual biological connection” between ADHD and OUD, noting that there are many reasons why patients with ADHD may be more prone to developing such a disorder.

Perhaps they did not get an ADHD diagnosis as a child, “which led to impairment in their ability to be successful at school and then in a job,” which in turn predisposed them to having a substance use disorder, said Dr. Park.

From previous research and his own clinical experience, ADHD can significantly affect quality of life and “cause increased impairment” in patients with a substance use disorder, he added.

Interestingly, there’s evidence suggesting patients treated for ADHD early in life are less likely to develop a substance use disorder later on, he said.

The “gold standard” treatment for ADHD is a prescription stimulant, which carries its own addiction risks. “So the issue is about whether or not to prescribe risky medications and how to weigh the risks and benefits,” said Dr. Park.

From a private health insurance database, researchers examined records for patients aged 18-64 years who were receiving medication for OUD, including buprenorphine, methadone, or naltrexone, from 2007-2017.

In the study sample, about 17,000 individuals were receiving stimulants, and 156,000 were not receiving these drugs. The largest percentage of participants in both groups was in the age-18-to-25 category.

About 35% of those receiving stimulants had ADHD, and about the same percentage had a mood disorder diagnosis.

Percentage of co-occurring ADHD and OUD increased from more than 4% in 2007 to more than 14% in 2017. The prevalence of stimulant use plus medication for OUD also increased during that time.

The increase in ADHD diagnoses may reflect growing identification of the condition, Dr. Park noted. As the opioid problem became more apparent and additional treatments made available, “there were more health care contacts, more assessments, and more diagnoses, including of ADHD,” he said.
 

Risks versus benefits

Stimulants may also be risky in patients with OUD. Results from another study presented at the AAAP meeting showed these drugs were associated with an increased chance of poisoning in patients receiving buprenorphine.

However, Dr. Park is skeptical the combination of stimulants and buprenorphine “leads to a biological risk of overdose.” He used a hypothetical scenario where other factors play into the connection: A patient gets a prescription stimulant, becomes addicted, then starts using street or illicit stimulants, which leads to a relapse on opioids, and then to an overdose.

Dr. Park noted that the same study that found an increased poisoning risk in stimulant users also found that patients tend to stay on buprenorphine treatment, providing protection against overdose.

“So there are risks and benefits of prescribing these medications, and it becomes tricky to know whether to prescribe them or not,” he said.

While stimulants are by far the best treatment for ADHD, atomoxetine (Strattera), a nonstimulant medication with antidepressant effects is another option, Dr. Park said.

He added that a limitation of his study was that very few individuals in the database received methadone.

A version of this article first appeared on Medscape.com.

A growing number of patients with opioid use disorder (OUD) have a diagnosis of comorbid attention-deficit/hyperactivity disorder (ADHD), raising issues about whether it’s appropriate to prescribe stimulants in this patient population.

One new study showed that from 2007-2017, there was a threefold increase in OUD and comorbid ADHD and that a significant number of these patients received prescription stimulants.

“This is the beginning stages of looking at whether or not there are risks of prescribing stimulants to patients who are on medications for opioid use disorder,” investigator Tae Woo (Ted) Park, MD, assistant professor, department of psychiatry, University of Pittsburgh School of Medicine, told this news organization.

“More and more people are being identified with ADHD, and we need to do more research on the best way to manage this patient group,” Dr. Park added.

The findings were presented at the annual meeting of the American Academy of Addiction Psychiatry.
 

Biological connection?

Dr. Park is not convinced there is “an actual biological connection” between ADHD and OUD, noting that there are many reasons why patients with ADHD may be more prone to developing such a disorder.

Perhaps they did not get an ADHD diagnosis as a child, “which led to impairment in their ability to be successful at school and then in a job,” which in turn predisposed them to having a substance use disorder, said Dr. Park.

From previous research and his own clinical experience, ADHD can significantly affect quality of life and “cause increased impairment” in patients with a substance use disorder, he added.

Interestingly, there’s evidence suggesting patients treated for ADHD early in life are less likely to develop a substance use disorder later on, he said.

The “gold standard” treatment for ADHD is a prescription stimulant, which carries its own addiction risks. “So the issue is about whether or not to prescribe risky medications and how to weigh the risks and benefits,” said Dr. Park.

From a private health insurance database, researchers examined records for patients aged 18-64 years who were receiving medication for OUD, including buprenorphine, methadone, or naltrexone, from 2007-2017.

In the study sample, about 17,000 individuals were receiving stimulants, and 156,000 were not receiving these drugs. The largest percentage of participants in both groups was in the age-18-to-25 category.

About 35% of those receiving stimulants had ADHD, and about the same percentage had a mood disorder diagnosis.

Percentage of co-occurring ADHD and OUD increased from more than 4% in 2007 to more than 14% in 2017. The prevalence of stimulant use plus medication for OUD also increased during that time.

The increase in ADHD diagnoses may reflect growing identification of the condition, Dr. Park noted. As the opioid problem became more apparent and additional treatments made available, “there were more health care contacts, more assessments, and more diagnoses, including of ADHD,” he said.
 

Risks versus benefits

Stimulants may also be risky in patients with OUD. Results from another study presented at the AAAP meeting showed these drugs were associated with an increased chance of poisoning in patients receiving buprenorphine.

However, Dr. Park is skeptical the combination of stimulants and buprenorphine “leads to a biological risk of overdose.” He used a hypothetical scenario where other factors play into the connection: A patient gets a prescription stimulant, becomes addicted, then starts using street or illicit stimulants, which leads to a relapse on opioids, and then to an overdose.

Dr. Park noted that the same study that found an increased poisoning risk in stimulant users also found that patients tend to stay on buprenorphine treatment, providing protection against overdose.

“So there are risks and benefits of prescribing these medications, and it becomes tricky to know whether to prescribe them or not,” he said.

While stimulants are by far the best treatment for ADHD, atomoxetine (Strattera), a nonstimulant medication with antidepressant effects is another option, Dr. Park said.

He added that a limitation of his study was that very few individuals in the database received methadone.

A version of this article first appeared on Medscape.com.

_{Text copyright DenseBreast-info.org.}

Answer

A. For women with extremely dense breasts who are not otherwise at increased risk for breast cancer, screening magnetic resonance imaging (MRI) is preferred, plus her mammogram or tomosynthesis. If MRI is not an option, consider ultrasonography or contrast-enhanced mammography. 

The same screening considerations apply to women with heterogeneously dense breasts; however, there is limited capacity for MRI or even ultrasound screening at many facilities. Research supports MRI in dense breasts, and abbreviated, lower-cost protocols have been validated that address some of the barriers to MRI.¹ Although not yet widely available, abbreviated MRI will likely have a greater role in screening women with dense breasts who are not high risk. It is important to note that preauthorization from insurance may be required for screening MRI, and in most US states, deductibles and copays apply.

The exam

Contrast-enhanced MRI requires IV injection of gadolinium-based contrast to look at the anatomy and blood flow patterns of the breast tissue. The patient lies face down with the breasts placed in two rectangular openings, or “coils.” The exam takes place inside the tunnel of the scanner, with the head facing out.After initial images are obtained, the contrast agent is injected into a vein in the arm, and additional images are taken, which will show areas of enhancement. The exam takes about 20 to 40 minutes. An “abbreviated” MRI can be performed for screening in some centers, which uses fewer sequences and takes about 10 minutes. 

Benefits

At least 40% of cancers are missed on mammography in women with dense breasts.² MRI is the most widely studied technique using a contrast agent, and it produces the highest additional cancer detection of all the supplemental technologies to date, yielding, in the first year, 10-16 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Berg et al.³). The cancer-detection benefit is seen across all breast density categories, even among average-risk women.⁴ There is no ionizing radiation, and it has been shown to reduce the rate of interval cancers (those detected due to symptoms after a negative screening mammogram), as well as the rate of late-stage disease. Axillary lymph nodes can be examined at the same screening exam. 

While tomosynthesis improves cancer detection in women with fatty breasts, scattered fibroglandular breast tissue, and heterogeneously dense breasts, it does not significantly improve cancer detection in women with extremely dense breasts.^5,6 Current American Cancer Society and National Comprehensive Cancer Network guidelines recommend annual screening MRI for women at high risk for breast cancer (regardless of breast density); however, increasingly, research supports the effectiveness of MRI in women with dense breasts who are otherwise considered average risk. A large randomized controlled trial in the Netherlands compared outcomes in women with extremely dense breasts invited to have screening MRI after negative mammography to those assigned to continue receiving screening mammography only. The incremental cancer detection rate was 16.5 per 1,000 (79/4,783) women screened with MRI in the first round⁷ and 6 per 1,000 women screened in the second round 2 years later.⁸ The interval cancer rate was 0.8 per 1,000 (4/4,783) women screened with MRI, compared with 4.9 per 1,000 (16/3,278) women who declined MRI and received mammography only.⁷ 

Screening ultrasound will show up to 3 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Vourtsis and Berg⁹ and Berg and Vourtsis¹⁰), far lower than the added cancer-detection rate of MRI. Consider screening ultrasound for women who cannot tolerate or access screening MRI.¹¹ Contrast-enhanced mammography (CEM) uses iodinated contrast (as in computed tomography). CEM is not widely available but appears to show cancer-detection similar to MRI. For further discussion, see Berg et al’s 2021 review.³ 

The FIGURE shows an example of an invasive cancer depicted on contrast-enhanced MRI in a 53-year-old woman with dense breasts and a family history of breast cancer that was not visible on tomosynthesis, even in retrospect, due to masking by dense tissue. 

Considerations

Breast MRI increases callbacks even after mammography and ultrasound; however, such false alarms are reduced in subsequent screening rounds. MRI cannot be performed in women who have certain metal implants— some pacemakers or spinal fixation rods—and is not recommended for pregnant women. Claustrophobia may be an issue for some women. MRI is expensive and requires IV contrast. Gadolinium is known to accumulate in the brain, although the long-term effects of this are unknown and no harm has been shown.●

_{Text copyright DenseBreast-info.org.}

Answer

A. For women with extremely dense breasts who are not otherwise at increased risk for breast cancer, screening magnetic resonance imaging (MRI) is preferred, plus her mammogram or tomosynthesis. If MRI is not an option, consider ultrasonography or contrast-enhanced mammography. 

The same screening considerations apply to women with heterogeneously dense breasts; however, there is limited capacity for MRI or even ultrasound screening at many facilities. Research supports MRI in dense breasts, and abbreviated, lower-cost protocols have been validated that address some of the barriers to MRI.¹ Although not yet widely available, abbreviated MRI will likely have a greater role in screening women with dense breasts who are not high risk. It is important to note that preauthorization from insurance may be required for screening MRI, and in most US states, deductibles and copays apply.

The exam

Contrast-enhanced MRI requires IV injection of gadolinium-based contrast to look at the anatomy and blood flow patterns of the breast tissue. The patient lies face down with the breasts placed in two rectangular openings, or “coils.” The exam takes place inside the tunnel of the scanner, with the head facing out.After initial images are obtained, the contrast agent is injected into a vein in the arm, and additional images are taken, which will show areas of enhancement. The exam takes about 20 to 40 minutes. An “abbreviated” MRI can be performed for screening in some centers, which uses fewer sequences and takes about 10 minutes. 

Benefits

At least 40% of cancers are missed on mammography in women with dense breasts.² MRI is the most widely studied technique using a contrast agent, and it produces the highest additional cancer detection of all the supplemental technologies to date, yielding, in the first year, 10-16 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Berg et al.³). The cancer-detection benefit is seen across all breast density categories, even among average-risk women.⁴ There is no ionizing radiation, and it has been shown to reduce the rate of interval cancers (those detected due to symptoms after a negative screening mammogram), as well as the rate of late-stage disease. Axillary lymph nodes can be examined at the same screening exam. 

While tomosynthesis improves cancer detection in women with fatty breasts, scattered fibroglandular breast tissue, and heterogeneously dense breasts, it does not significantly improve cancer detection in women with extremely dense breasts.^5,6 Current American Cancer Society and National Comprehensive Cancer Network guidelines recommend annual screening MRI for women at high risk for breast cancer (regardless of breast density); however, increasingly, research supports the effectiveness of MRI in women with dense breasts who are otherwise considered average risk. A large randomized controlled trial in the Netherlands compared outcomes in women with extremely dense breasts invited to have screening MRI after negative mammography to those assigned to continue receiving screening mammography only. The incremental cancer detection rate was 16.5 per 1,000 (79/4,783) women screened with MRI in the first round⁷ and 6 per 1,000 women screened in the second round 2 years later.⁸ The interval cancer rate was 0.8 per 1,000 (4/4,783) women screened with MRI, compared with 4.9 per 1,000 (16/3,278) women who declined MRI and received mammography only.⁷ 

Screening ultrasound will show up to 3 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Vourtsis and Berg⁹ and Berg and Vourtsis¹⁰), far lower than the added cancer-detection rate of MRI. Consider screening ultrasound for women who cannot tolerate or access screening MRI.¹¹ Contrast-enhanced mammography (CEM) uses iodinated contrast (as in computed tomography). CEM is not widely available but appears to show cancer-detection similar to MRI. For further discussion, see Berg et al’s 2021 review.³ 

The FIGURE shows an example of an invasive cancer depicted on contrast-enhanced MRI in a 53-year-old woman with dense breasts and a family history of breast cancer that was not visible on tomosynthesis, even in retrospect, due to masking by dense tissue. 

Considerations

Breast MRI increases callbacks even after mammography and ultrasound; however, such false alarms are reduced in subsequent screening rounds. MRI cannot be performed in women who have certain metal implants— some pacemakers or spinal fixation rods—and is not recommended for pregnant women. Claustrophobia may be an issue for some women. MRI is expensive and requires IV contrast. Gadolinium is known to accumulate in the brain, although the long-term effects of this are unknown and no harm has been shown.●

_{Text copyright DenseBreast-info.org.}

Answer

A. For women with extremely dense breasts who are not otherwise at increased risk for breast cancer, screening magnetic resonance imaging (MRI) is preferred, plus her mammogram or tomosynthesis. If MRI is not an option, consider ultrasonography or contrast-enhanced mammography. 

The same screening considerations apply to women with heterogeneously dense breasts; however, there is limited capacity for MRI or even ultrasound screening at many facilities. Research supports MRI in dense breasts, and abbreviated, lower-cost protocols have been validated that address some of the barriers to MRI.¹ Although not yet widely available, abbreviated MRI will likely have a greater role in screening women with dense breasts who are not high risk. It is important to note that preauthorization from insurance may be required for screening MRI, and in most US states, deductibles and copays apply.

The exam

Contrast-enhanced MRI requires IV injection of gadolinium-based contrast to look at the anatomy and blood flow patterns of the breast tissue. The patient lies face down with the breasts placed in two rectangular openings, or “coils.” The exam takes place inside the tunnel of the scanner, with the head facing out.After initial images are obtained, the contrast agent is injected into a vein in the arm, and additional images are taken, which will show areas of enhancement. The exam takes about 20 to 40 minutes. An “abbreviated” MRI can be performed for screening in some centers, which uses fewer sequences and takes about 10 minutes. 

Benefits

At least 40% of cancers are missed on mammography in women with dense breasts.² MRI is the most widely studied technique using a contrast agent, and it produces the highest additional cancer detection of all the supplemental technologies to date, yielding, in the first year, 10-16 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Berg et al.³). The cancer-detection benefit is seen across all breast density categories, even among average-risk women.⁴ There is no ionizing radiation, and it has been shown to reduce the rate of interval cancers (those detected due to symptoms after a negative screening mammogram), as well as the rate of late-stage disease. Axillary lymph nodes can be examined at the same screening exam. 

While tomosynthesis improves cancer detection in women with fatty breasts, scattered fibroglandular breast tissue, and heterogeneously dense breasts, it does not significantly improve cancer detection in women with extremely dense breasts.^5,6 Current American Cancer Society and National Comprehensive Cancer Network guidelines recommend annual screening MRI for women at high risk for breast cancer (regardless of breast density); however, increasingly, research supports the effectiveness of MRI in women with dense breasts who are otherwise considered average risk. A large randomized controlled trial in the Netherlands compared outcomes in women with extremely dense breasts invited to have screening MRI after negative mammography to those assigned to continue receiving screening mammography only. The incremental cancer detection rate was 16.5 per 1,000 (79/4,783) women screened with MRI in the first round⁷ and 6 per 1,000 women screened in the second round 2 years later.⁸ The interval cancer rate was 0.8 per 1,000 (4/4,783) women screened with MRI, compared with 4.9 per 1,000 (16/3,278) women who declined MRI and received mammography only.⁷ 

Screening ultrasound will show up to 3 additional cancers per 1,000 women screened after mammography/tomosynthesis (reviewed in Vourtsis and Berg⁹ and Berg and Vourtsis¹⁰), far lower than the added cancer-detection rate of MRI. Consider screening ultrasound for women who cannot tolerate or access screening MRI.¹¹ Contrast-enhanced mammography (CEM) uses iodinated contrast (as in computed tomography). CEM is not widely available but appears to show cancer-detection similar to MRI. For further discussion, see Berg et al’s 2021 review.³ 

The FIGURE shows an example of an invasive cancer depicted on contrast-enhanced MRI in a 53-year-old woman with dense breasts and a family history of breast cancer that was not visible on tomosynthesis, even in retrospect, due to masking by dense tissue. 

Considerations

Breast MRI increases callbacks even after mammography and ultrasound; however, such false alarms are reduced in subsequent screening rounds. MRI cannot be performed in women who have certain metal implants— some pacemakers or spinal fixation rods—and is not recommended for pregnant women. Claustrophobia may be an issue for some women. MRI is expensive and requires IV contrast. Gadolinium is known to accumulate in the brain, although the long-term effects of this are unknown and no harm has been shown.●