A novel blood test has shown promise for colorectal cancer screening.

The “multiomics” test, under development by Freenome, has previously been shown to detect early-stage (I/II) colorectal cancer with a sensitivity of 94% and a specificity of 94%.

A new study shows that it can also detect precancerous lesions, colorectal advanced adenomas (AAs).

“The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous,” senior author Aasma Shaukat, MD, MPH, chief of gastroenterology at Minneapolis VA Health Care System and professor of medicine at the University of Minnesota, Minneapolis, said in a statement.

At the Gastrointestinal Cancers Symposium 2021, she presented data showing that the novel test was able to detect AAs with a sensitivity of 41% and a specificity of 90%.

This sensitivity of the new test is better than or similar to that of currently available stool tests, noted study author C. Jimmy Lin, MD, PhD, MHS, chief scientific officer at Freenome.

The new test had almost double the sensitivity for detecting AAs (41% vs. 24%) as the fecal immunochemical test (FIT), and its sensitivity was comparable to that of FIT-DNA testing (41% vs. 42%).

In addition, it showed much higher sensitivity (41% vs 22%) for detecting AAs than the Epi proColon, a screening blood test that has been approved by the U.S. Food and Drug Administration for detecting methylated septin 9 DNA (mSEPT9).

“What’s special about our company is ... that we use a multinomic technology, meaning we look at DNA, RNA, protein, and other biomarkers – all of these things together,” Dr. Lin told this news organization.

Their platform integrates assays for circulating free DNA, methylation, and proteins using advanced computational biology and machine-learning techniques, which provide a multidimensional view of both tumor- and immune-derived signatures that enable the early detection of cancer.

In contrast to other blood tests that are under development for cancer screening, some of which claim to detect several common cancer types, Freenome is focusing on only colorectal cancer. “There are other companies in the early-detection space, but some of them are doing multicancer screening and have a generalized product,” said Dr. Lin. “Our approach is to focus on a specific cancer type, and we are beginning with colorectal cancer screening, and then will expand to other types.”
 

Better sensitivity

The study that was presented at the meeting evaluated the novel multiomics blood test for AA detection.

Blood samples were obtained from participants in the AI-EMERGE study, a prospective, multicenter study that included primarily average-risk screening patients from 30 clinical sites in the United States and Canada. The study included a total of 542 samples, including 122 histopathologically confirmed AAs and 420 colonoscopy-confirmed negative control samples.

AA sensitivity of the novel test was greater than that with the mSEPT9 test, which is the only blood test currently available for colorectal cancer screening. The new test’s sensitivity was much higher than that of FIT and was comparable to that of FIT-DNA. Sensitivity increased with increasing lesion size and was consistent across location and histology except for serrated lesions, the authors noted in the abstract.

“By combining signatures from both tumor and non–tumor-derived sources, our multiomics signatures detect twice as many AAs as methylation only or single-protein approaches,” Dr. Lin said. “And we have now shown that sensitive AA detection at a level similar to or better than currently available stool tests is achievable in blood, which is necessary for effective early detection and prevention of colorectal cancers.”

The company has begun the regulatory process for having the test approved by the FDA. The company’s goal is to enroll 14,000 participants and have prospectively collected data.

The research was funded by Freenome. Dr. Lin is the chief scientific officer at Freenome and has relationships with Labroots, Natera, and Neon Therapeutics. Shaukat has relationships with Freenome and Iterative Scopes.

Help your patients understand colorectal cancer prevention, and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

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

A novel blood test has shown promise for colorectal cancer screening.

The “multiomics” test, under development by Freenome, has previously been shown to detect early-stage (I/II) colorectal cancer with a sensitivity of 94% and a specificity of 94%.

A new study shows that it can also detect precancerous lesions, colorectal advanced adenomas (AAs).

“The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous,” senior author Aasma Shaukat, MD, MPH, chief of gastroenterology at Minneapolis VA Health Care System and professor of medicine at the University of Minnesota, Minneapolis, said in a statement.

At the Gastrointestinal Cancers Symposium 2021, she presented data showing that the novel test was able to detect AAs with a sensitivity of 41% and a specificity of 90%.

This sensitivity of the new test is better than or similar to that of currently available stool tests, noted study author C. Jimmy Lin, MD, PhD, MHS, chief scientific officer at Freenome.

The new test had almost double the sensitivity for detecting AAs (41% vs. 24%) as the fecal immunochemical test (FIT), and its sensitivity was comparable to that of FIT-DNA testing (41% vs. 42%).

In addition, it showed much higher sensitivity (41% vs 22%) for detecting AAs than the Epi proColon, a screening blood test that has been approved by the U.S. Food and Drug Administration for detecting methylated septin 9 DNA (mSEPT9).

“What’s special about our company is ... that we use a multinomic technology, meaning we look at DNA, RNA, protein, and other biomarkers – all of these things together,” Dr. Lin told this news organization.

Their platform integrates assays for circulating free DNA, methylation, and proteins using advanced computational biology and machine-learning techniques, which provide a multidimensional view of both tumor- and immune-derived signatures that enable the early detection of cancer.

In contrast to other blood tests that are under development for cancer screening, some of which claim to detect several common cancer types, Freenome is focusing on only colorectal cancer. “There are other companies in the early-detection space, but some of them are doing multicancer screening and have a generalized product,” said Dr. Lin. “Our approach is to focus on a specific cancer type, and we are beginning with colorectal cancer screening, and then will expand to other types.”
 

Better sensitivity

The study that was presented at the meeting evaluated the novel multiomics blood test for AA detection.

Blood samples were obtained from participants in the AI-EMERGE study, a prospective, multicenter study that included primarily average-risk screening patients from 30 clinical sites in the United States and Canada. The study included a total of 542 samples, including 122 histopathologically confirmed AAs and 420 colonoscopy-confirmed negative control samples.

AA sensitivity of the novel test was greater than that with the mSEPT9 test, which is the only blood test currently available for colorectal cancer screening. The new test’s sensitivity was much higher than that of FIT and was comparable to that of FIT-DNA. Sensitivity increased with increasing lesion size and was consistent across location and histology except for serrated lesions, the authors noted in the abstract.

“By combining signatures from both tumor and non–tumor-derived sources, our multiomics signatures detect twice as many AAs as methylation only or single-protein approaches,” Dr. Lin said. “And we have now shown that sensitive AA detection at a level similar to or better than currently available stool tests is achievable in blood, which is necessary for effective early detection and prevention of colorectal cancers.”

The company has begun the regulatory process for having the test approved by the FDA. The company’s goal is to enroll 14,000 participants and have prospectively collected data.

The research was funded by Freenome. Dr. Lin is the chief scientific officer at Freenome and has relationships with Labroots, Natera, and Neon Therapeutics. Shaukat has relationships with Freenome and Iterative Scopes.

Help your patients understand colorectal cancer prevention, and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

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

A novel blood test has shown promise for colorectal cancer screening.

The “multiomics” test, under development by Freenome, has previously been shown to detect early-stage (I/II) colorectal cancer with a sensitivity of 94% and a specificity of 94%.

A new study shows that it can also detect precancerous lesions, colorectal advanced adenomas (AAs).

“The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous,” senior author Aasma Shaukat, MD, MPH, chief of gastroenterology at Minneapolis VA Health Care System and professor of medicine at the University of Minnesota, Minneapolis, said in a statement.

At the Gastrointestinal Cancers Symposium 2021, she presented data showing that the novel test was able to detect AAs with a sensitivity of 41% and a specificity of 90%.

This sensitivity of the new test is better than or similar to that of currently available stool tests, noted study author C. Jimmy Lin, MD, PhD, MHS, chief scientific officer at Freenome.

The new test had almost double the sensitivity for detecting AAs (41% vs. 24%) as the fecal immunochemical test (FIT), and its sensitivity was comparable to that of FIT-DNA testing (41% vs. 42%).

In addition, it showed much higher sensitivity (41% vs 22%) for detecting AAs than the Epi proColon, a screening blood test that has been approved by the U.S. Food and Drug Administration for detecting methylated septin 9 DNA (mSEPT9).

“What’s special about our company is ... that we use a multinomic technology, meaning we look at DNA, RNA, protein, and other biomarkers – all of these things together,” Dr. Lin told this news organization.

Their platform integrates assays for circulating free DNA, methylation, and proteins using advanced computational biology and machine-learning techniques, which provide a multidimensional view of both tumor- and immune-derived signatures that enable the early detection of cancer.

In contrast to other blood tests that are under development for cancer screening, some of which claim to detect several common cancer types, Freenome is focusing on only colorectal cancer. “There are other companies in the early-detection space, but some of them are doing multicancer screening and have a generalized product,” said Dr. Lin. “Our approach is to focus on a specific cancer type, and we are beginning with colorectal cancer screening, and then will expand to other types.”
 

Better sensitivity

The study that was presented at the meeting evaluated the novel multiomics blood test for AA detection.

Blood samples were obtained from participants in the AI-EMERGE study, a prospective, multicenter study that included primarily average-risk screening patients from 30 clinical sites in the United States and Canada. The study included a total of 542 samples, including 122 histopathologically confirmed AAs and 420 colonoscopy-confirmed negative control samples.

AA sensitivity of the novel test was greater than that with the mSEPT9 test, which is the only blood test currently available for colorectal cancer screening. The new test’s sensitivity was much higher than that of FIT and was comparable to that of FIT-DNA. Sensitivity increased with increasing lesion size and was consistent across location and histology except for serrated lesions, the authors noted in the abstract.

“By combining signatures from both tumor and non–tumor-derived sources, our multiomics signatures detect twice as many AAs as methylation only or single-protein approaches,” Dr. Lin said. “And we have now shown that sensitive AA detection at a level similar to or better than currently available stool tests is achievable in blood, which is necessary for effective early detection and prevention of colorectal cancers.”

The company has begun the regulatory process for having the test approved by the FDA. The company’s goal is to enroll 14,000 participants and have prospectively collected data.

The research was funded by Freenome. Dr. Lin is the chief scientific officer at Freenome and has relationships with Labroots, Natera, and Neon Therapeutics. Shaukat has relationships with Freenome and Iterative Scopes.

Help your patients understand colorectal cancer prevention, and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

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

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

[email protected]

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

[email protected]

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

[email protected]

The Blitz was a Nazi bombing campaign targeting London. It was designed to break the spirit of the British. Knowing London would be the centerpiece of the campaign, the British rather hastily established several psychiatric hospitals for the expected panic in the streets. However, despite 9 months of bombing, 43,000 civilians killed and 139,000 more wounded, the predicted chaos in the streets did not manifest. Civilians continued to work, industry continued to churn, and eventually, Hitler’s eye turned east toward Russia.

H. F. Davis/Wikimedia Commons/Public Domain

The surprising lack of pandemonium in London inspired Dr. John T. MacCurdy, who chronicled his findings in a book The Structure of Morale, more recently popularized in Malcolm Gladwell’s David and Goliath. A brief summary of Dr. MacCurdy’s theory divides the targeted Londoners into the following categories:

• Direct hit
• Near miss
• Remote miss

The direct hit group was defined as those killed by the bombing. However, As Dr. MacCurdy stated, “The morale of the community depends on the reaction of the survivors…Put this way, the fact is obvious, corpses do not run about spreading panic.”

A near miss were those for whom wounds were inflicted or loved ones were killed. This group felt the real repercussions of the bombing. However, with 139,000 wounded out of a city of 8 million people, they were a small minority.

The majority of Londoners, then, fit into the third group – the remote miss. These people faced a serious fear, but survived, often totally unscathed. The process of facing that fear without having panicked or having been harmed, then, led to “a feeling of excitement with a flavour of invulnerability.”

Therefore, rather than a city of millions running in fear in the streets, requiring military presence to control the chaos, London became a city of people who felt themselves, perhaps, invincible.

A similar threat passed through the world in the first several months of the COVID-19 pandemic. Hospitals were expected to be overrun, and ethics committees convened to discuss allocation of scarce ventilators. However, due, at least in part, to the impressive efforts of the populace of the United States, the majority of civilians did not feel the burden of this frightening disease. Certainly, in a few places, hospitals were overwhelmed, and resources were unavailable due to sheer numbers. These places saw those who suffered direct hits with the highest frequency. However, a disease with an infection fatality ratio recently estimated at 0.5-1%, with a relatively high rate of asymptomatic disease, led to a large majority of people who experienced the first wave of COVID-19 in the United States as a remote miss. COVID-19’s flattened first peak gave much of the population a sense of relief, and, perhaps, a “flavour of invulnerability.”

An anonymous, but concerned, household contact wrote The New York Times and illustrated perfectly the invulnerable feelings of a remote miss:

“I’m doing my best to avoid social contact, along with two other members of my household. We have sufficient supplies for a month. Despite that, one member insists on going out for trivial reasons, such as not liking the kind of apples we have. He’s 92. I’ve tried explaining and cajoling, using graphs and anecdotes to make the danger to all of us seem ‘real.’ It doesn’t take. His risk of death is many times greater than mine, and he’s poking holes in a lifeboat we all have to rely on. What is the correct path?”

American culture expects certainty from science. Therein lies the problem with a new disease no medical provider or researcher had seen prior to November 2019. Action was required in the effort to slow the spread with little to no data as a guide. Therefore, messages that seemed contradictory reached the public. “A mask less than N-95 grade will not protect you,” evolved to, “everyone should wear a homemade cloth mask.” As the pandemic evolved and data was gathered, new recommendations were presented. Unfortunately, such well-meaning and necessary changes led to confusion, mistrust, and conspiracy theories.

Medicine’s response

The science of COVID-19 carries phenomenal uncertainties, but the psychology of those who have suffered direct hits or near misses are the daily bedside challenge of all physicians, but particularly of hospitalists. We live at the front lines of disease – as one colleague put it to me, “we are the watchers on the wall.” Though we do not yet have our hoped-for, evidence-based treatment for this virus, we are familiar with acute illness. We know the rapid change of health to disease, and we know the chronically ill who suffer exacerbations of such illness. Supporting patients and their loved ones through those times is our daily practice.

On the other hand, those who have experienced only remote misses remain vulnerable in this pandemic, despite their feelings of invincibility. Those that feel invincible may be the least interested in our advice. This, too, is no strange position for a physician. We have tools to reach patients who do not reach out to us. Traditional media outlets have been saturated with headlines and talking points about this disease. Physicians who have taken to social media have been met with appreciation in some situations, but ignored, doubted, or shunned in others. In May 2020, NBC News reported an ED doctor’s attempt to dispel some COVID myths on social media. Unfortunately, his remarks were summarily dismissed. Through the frustration, we persevere.

Out of the many responsible authorities who help battle misinformation, the World Health Organization’s mythbusting website (www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters) directly confronts many incorrect circulating ideas. My personal favorite at the time of this writing is: “Being able to hold your breath for 10 seconds or more without coughing or feeling discomfort DOES NOT mean you are free from COVID-19.”

For the policy and communication side of medicine in the midst of this pandemic, I will not claim to have a silver bullet. There are many intelligent, policy-minded people who are working on that very problem. However, as individual practitioners and as individual citizens, I can see two powerful tools that may help us move forward.

1) Confidence and humility: We live in a world of uncertainty, and we struggle against that every day. This pandemic has put our uncertainty clearly on display. However, we may also be confident in providing the best currently known care, even while holding the humility that what we know will likely change. Before COVID-19, we have all seen patients who received multiple different answers from multiple different providers. When I am willing to admit my uncertainty, I have witnessed patients’ skepticism transform into assuming an active role in their care.

For those who have suffered a direct hit or a near miss, honest conversations are vital to build a trusting physician-patient relationship. For the remote miss group, speaking candidly about our uncertainty displays our authenticity and helps combat conspiracy-type theories of ulterior motives. This becomes all the more crucial when new technologies are being deployed – for instance, a September 2020 CBS News survey showed only 21% of Americans planned to get a COVID-19 vaccine “as soon as possible.”

2) Insight into our driving emotions: While the near miss patients are likely ready to continue prevention measures, the remote miss group is often more difficult. When we do have the opportunity to discuss actions to impede the virus’ spread with the remote miss group, understanding their potentially unrecognized motivations helps with that conversation. I have shared the story of the London Blitz and the remote miss and seen people connect the dots with their own emotions. Effective counseling – expecting the feelings of invulnerability amongst the remote miss group – can support endurance with prevention measures amongst that group and help flatten the curve.

Communicating our strengths, transparently discussing our weaknesses, and better understanding underlying emotions for ourselves and our patients may help save lives. As physicians, that is our daily practice, unchanged even as medicine takes center stage in our national conversation.

Dr. Walthall completed his internal medicine residency at the Medical University of South Carolina in Charleston, SC. After residency, he joined the faculty at MUSC in the Division of Hospital Medicine. He is also interested in systems-based care and has taken on the role of physician advisor. This essay appeared first on The Hospital Leader, the official blog of SHM.

The Blitz was a Nazi bombing campaign targeting London. It was designed to break the spirit of the British. Knowing London would be the centerpiece of the campaign, the British rather hastily established several psychiatric hospitals for the expected panic in the streets. However, despite 9 months of bombing, 43,000 civilians killed and 139,000 more wounded, the predicted chaos in the streets did not manifest. Civilians continued to work, industry continued to churn, and eventually, Hitler’s eye turned east toward Russia.

H. F. Davis/Wikimedia Commons/Public Domain

The surprising lack of pandemonium in London inspired Dr. John T. MacCurdy, who chronicled his findings in a book The Structure of Morale, more recently popularized in Malcolm Gladwell’s David and Goliath. A brief summary of Dr. MacCurdy’s theory divides the targeted Londoners into the following categories:

• Direct hit
• Near miss
• Remote miss

The direct hit group was defined as those killed by the bombing. However, As Dr. MacCurdy stated, “The morale of the community depends on the reaction of the survivors…Put this way, the fact is obvious, corpses do not run about spreading panic.”

A near miss were those for whom wounds were inflicted or loved ones were killed. This group felt the real repercussions of the bombing. However, with 139,000 wounded out of a city of 8 million people, they were a small minority.

The majority of Londoners, then, fit into the third group – the remote miss. These people faced a serious fear, but survived, often totally unscathed. The process of facing that fear without having panicked or having been harmed, then, led to “a feeling of excitement with a flavour of invulnerability.”

Therefore, rather than a city of millions running in fear in the streets, requiring military presence to control the chaos, London became a city of people who felt themselves, perhaps, invincible.

A similar threat passed through the world in the first several months of the COVID-19 pandemic. Hospitals were expected to be overrun, and ethics committees convened to discuss allocation of scarce ventilators. However, due, at least in part, to the impressive efforts of the populace of the United States, the majority of civilians did not feel the burden of this frightening disease. Certainly, in a few places, hospitals were overwhelmed, and resources were unavailable due to sheer numbers. These places saw those who suffered direct hits with the highest frequency. However, a disease with an infection fatality ratio recently estimated at 0.5-1%, with a relatively high rate of asymptomatic disease, led to a large majority of people who experienced the first wave of COVID-19 in the United States as a remote miss. COVID-19’s flattened first peak gave much of the population a sense of relief, and, perhaps, a “flavour of invulnerability.”

An anonymous, but concerned, household contact wrote The New York Times and illustrated perfectly the invulnerable feelings of a remote miss:

“I’m doing my best to avoid social contact, along with two other members of my household. We have sufficient supplies for a month. Despite that, one member insists on going out for trivial reasons, such as not liking the kind of apples we have. He’s 92. I’ve tried explaining and cajoling, using graphs and anecdotes to make the danger to all of us seem ‘real.’ It doesn’t take. His risk of death is many times greater than mine, and he’s poking holes in a lifeboat we all have to rely on. What is the correct path?”

American culture expects certainty from science. Therein lies the problem with a new disease no medical provider or researcher had seen prior to November 2019. Action was required in the effort to slow the spread with little to no data as a guide. Therefore, messages that seemed contradictory reached the public. “A mask less than N-95 grade will not protect you,” evolved to, “everyone should wear a homemade cloth mask.” As the pandemic evolved and data was gathered, new recommendations were presented. Unfortunately, such well-meaning and necessary changes led to confusion, mistrust, and conspiracy theories.

Medicine’s response

The science of COVID-19 carries phenomenal uncertainties, but the psychology of those who have suffered direct hits or near misses are the daily bedside challenge of all physicians, but particularly of hospitalists. We live at the front lines of disease – as one colleague put it to me, “we are the watchers on the wall.” Though we do not yet have our hoped-for, evidence-based treatment for this virus, we are familiar with acute illness. We know the rapid change of health to disease, and we know the chronically ill who suffer exacerbations of such illness. Supporting patients and their loved ones through those times is our daily practice.

On the other hand, those who have experienced only remote misses remain vulnerable in this pandemic, despite their feelings of invincibility. Those that feel invincible may be the least interested in our advice. This, too, is no strange position for a physician. We have tools to reach patients who do not reach out to us. Traditional media outlets have been saturated with headlines and talking points about this disease. Physicians who have taken to social media have been met with appreciation in some situations, but ignored, doubted, or shunned in others. In May 2020, NBC News reported an ED doctor’s attempt to dispel some COVID myths on social media. Unfortunately, his remarks were summarily dismissed. Through the frustration, we persevere.

Out of the many responsible authorities who help battle misinformation, the World Health Organization’s mythbusting website (www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters) directly confronts many incorrect circulating ideas. My personal favorite at the time of this writing is: “Being able to hold your breath for 10 seconds or more without coughing or feeling discomfort DOES NOT mean you are free from COVID-19.”

For the policy and communication side of medicine in the midst of this pandemic, I will not claim to have a silver bullet. There are many intelligent, policy-minded people who are working on that very problem. However, as individual practitioners and as individual citizens, I can see two powerful tools that may help us move forward.

1) Confidence and humility: We live in a world of uncertainty, and we struggle against that every day. This pandemic has put our uncertainty clearly on display. However, we may also be confident in providing the best currently known care, even while holding the humility that what we know will likely change. Before COVID-19, we have all seen patients who received multiple different answers from multiple different providers. When I am willing to admit my uncertainty, I have witnessed patients’ skepticism transform into assuming an active role in their care.

For those who have suffered a direct hit or a near miss, honest conversations are vital to build a trusting physician-patient relationship. For the remote miss group, speaking candidly about our uncertainty displays our authenticity and helps combat conspiracy-type theories of ulterior motives. This becomes all the more crucial when new technologies are being deployed – for instance, a September 2020 CBS News survey showed only 21% of Americans planned to get a COVID-19 vaccine “as soon as possible.”

2) Insight into our driving emotions: While the near miss patients are likely ready to continue prevention measures, the remote miss group is often more difficult. When we do have the opportunity to discuss actions to impede the virus’ spread with the remote miss group, understanding their potentially unrecognized motivations helps with that conversation. I have shared the story of the London Blitz and the remote miss and seen people connect the dots with their own emotions. Effective counseling – expecting the feelings of invulnerability amongst the remote miss group – can support endurance with prevention measures amongst that group and help flatten the curve.

Communicating our strengths, transparently discussing our weaknesses, and better understanding underlying emotions for ourselves and our patients may help save lives. As physicians, that is our daily practice, unchanged even as medicine takes center stage in our national conversation.

Dr. Walthall completed his internal medicine residency at the Medical University of South Carolina in Charleston, SC. After residency, he joined the faculty at MUSC in the Division of Hospital Medicine. He is also interested in systems-based care and has taken on the role of physician advisor. This essay appeared first on The Hospital Leader, the official blog of SHM.

The Blitz was a Nazi bombing campaign targeting London. It was designed to break the spirit of the British. Knowing London would be the centerpiece of the campaign, the British rather hastily established several psychiatric hospitals for the expected panic in the streets. However, despite 9 months of bombing, 43,000 civilians killed and 139,000 more wounded, the predicted chaos in the streets did not manifest. Civilians continued to work, industry continued to churn, and eventually, Hitler’s eye turned east toward Russia.

H. F. Davis/Wikimedia Commons/Public Domain

The surprising lack of pandemonium in London inspired Dr. John T. MacCurdy, who chronicled his findings in a book The Structure of Morale, more recently popularized in Malcolm Gladwell’s David and Goliath. A brief summary of Dr. MacCurdy’s theory divides the targeted Londoners into the following categories:

• Direct hit
• Near miss
• Remote miss

The direct hit group was defined as those killed by the bombing. However, As Dr. MacCurdy stated, “The morale of the community depends on the reaction of the survivors…Put this way, the fact is obvious, corpses do not run about spreading panic.”

A near miss were those for whom wounds were inflicted or loved ones were killed. This group felt the real repercussions of the bombing. However, with 139,000 wounded out of a city of 8 million people, they were a small minority.

The majority of Londoners, then, fit into the third group – the remote miss. These people faced a serious fear, but survived, often totally unscathed. The process of facing that fear without having panicked or having been harmed, then, led to “a feeling of excitement with a flavour of invulnerability.”

Therefore, rather than a city of millions running in fear in the streets, requiring military presence to control the chaos, London became a city of people who felt themselves, perhaps, invincible.

A similar threat passed through the world in the first several months of the COVID-19 pandemic. Hospitals were expected to be overrun, and ethics committees convened to discuss allocation of scarce ventilators. However, due, at least in part, to the impressive efforts of the populace of the United States, the majority of civilians did not feel the burden of this frightening disease. Certainly, in a few places, hospitals were overwhelmed, and resources were unavailable due to sheer numbers. These places saw those who suffered direct hits with the highest frequency. However, a disease with an infection fatality ratio recently estimated at 0.5-1%, with a relatively high rate of asymptomatic disease, led to a large majority of people who experienced the first wave of COVID-19 in the United States as a remote miss. COVID-19’s flattened first peak gave much of the population a sense of relief, and, perhaps, a “flavour of invulnerability.”

An anonymous, but concerned, household contact wrote The New York Times and illustrated perfectly the invulnerable feelings of a remote miss:

“I’m doing my best to avoid social contact, along with two other members of my household. We have sufficient supplies for a month. Despite that, one member insists on going out for trivial reasons, such as not liking the kind of apples we have. He’s 92. I’ve tried explaining and cajoling, using graphs and anecdotes to make the danger to all of us seem ‘real.’ It doesn’t take. His risk of death is many times greater than mine, and he’s poking holes in a lifeboat we all have to rely on. What is the correct path?”

American culture expects certainty from science. Therein lies the problem with a new disease no medical provider or researcher had seen prior to November 2019. Action was required in the effort to slow the spread with little to no data as a guide. Therefore, messages that seemed contradictory reached the public. “A mask less than N-95 grade will not protect you,” evolved to, “everyone should wear a homemade cloth mask.” As the pandemic evolved and data was gathered, new recommendations were presented. Unfortunately, such well-meaning and necessary changes led to confusion, mistrust, and conspiracy theories.

Medicine’s response

The science of COVID-19 carries phenomenal uncertainties, but the psychology of those who have suffered direct hits or near misses are the daily bedside challenge of all physicians, but particularly of hospitalists. We live at the front lines of disease – as one colleague put it to me, “we are the watchers on the wall.” Though we do not yet have our hoped-for, evidence-based treatment for this virus, we are familiar with acute illness. We know the rapid change of health to disease, and we know the chronically ill who suffer exacerbations of such illness. Supporting patients and their loved ones through those times is our daily practice.

On the other hand, those who have experienced only remote misses remain vulnerable in this pandemic, despite their feelings of invincibility. Those that feel invincible may be the least interested in our advice. This, too, is no strange position for a physician. We have tools to reach patients who do not reach out to us. Traditional media outlets have been saturated with headlines and talking points about this disease. Physicians who have taken to social media have been met with appreciation in some situations, but ignored, doubted, or shunned in others. In May 2020, NBC News reported an ED doctor’s attempt to dispel some COVID myths on social media. Unfortunately, his remarks were summarily dismissed. Through the frustration, we persevere.

Out of the many responsible authorities who help battle misinformation, the World Health Organization’s mythbusting website (www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters) directly confronts many incorrect circulating ideas. My personal favorite at the time of this writing is: “Being able to hold your breath for 10 seconds or more without coughing or feeling discomfort DOES NOT mean you are free from COVID-19.”

For the policy and communication side of medicine in the midst of this pandemic, I will not claim to have a silver bullet. There are many intelligent, policy-minded people who are working on that very problem. However, as individual practitioners and as individual citizens, I can see two powerful tools that may help us move forward.

1) Confidence and humility: We live in a world of uncertainty, and we struggle against that every day. This pandemic has put our uncertainty clearly on display. However, we may also be confident in providing the best currently known care, even while holding the humility that what we know will likely change. Before COVID-19, we have all seen patients who received multiple different answers from multiple different providers. When I am willing to admit my uncertainty, I have witnessed patients’ skepticism transform into assuming an active role in their care.

For those who have suffered a direct hit or a near miss, honest conversations are vital to build a trusting physician-patient relationship. For the remote miss group, speaking candidly about our uncertainty displays our authenticity and helps combat conspiracy-type theories of ulterior motives. This becomes all the more crucial when new technologies are being deployed – for instance, a September 2020 CBS News survey showed only 21% of Americans planned to get a COVID-19 vaccine “as soon as possible.”

2) Insight into our driving emotions: While the near miss patients are likely ready to continue prevention measures, the remote miss group is often more difficult. When we do have the opportunity to discuss actions to impede the virus’ spread with the remote miss group, understanding their potentially unrecognized motivations helps with that conversation. I have shared the story of the London Blitz and the remote miss and seen people connect the dots with their own emotions. Effective counseling – expecting the feelings of invulnerability amongst the remote miss group – can support endurance with prevention measures amongst that group and help flatten the curve.

Communicating our strengths, transparently discussing our weaknesses, and better understanding underlying emotions for ourselves and our patients may help save lives. As physicians, that is our daily practice, unchanged even as medicine takes center stage in our national conversation.

Dr. Walthall completed his internal medicine residency at the Medical University of South Carolina in Charleston, SC. After residency, he joined the faculty at MUSC in the Division of Hospital Medicine. He is also interested in systems-based care and has taken on the role of physician advisor. This essay appeared first on The Hospital Leader, the official blog of SHM.

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

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Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

Oral antibiotic treatment for 7-10 days works for most feverish children with uncomplicated urinary tract infection (UTI), reported Tej K. Mattoo, MD, of Wayne State University, Detroit, and associates.

A good clinical assessment supported by laboratory results using a clean urine specimen is crucial to accurately diagnosing UTI in children, Dr. Mattoo and colleagues reported in a state-of-the-art review article in Pediatrics.

The authors set out to summarize the current literature on UTI in children with the goal of guiding clinical management. They provide a thorough summary of the research on a wide range of issues, including pathogenesis of acute pyelonephritis and renal scarring, risk factors for UTI and renal scarring, diagnosis and common errors in diagnosis, complications of UTI and post-UTI renal imaging, antibiotics, antimicrobial prophylaxis, surgical interventions, and prevention of recurrent UTIs.
 

What key steps make all the difference?

To help guide practicing physicians through this wealth of information, Dr. Mattoo noted in an interview that, although the review article offers “many takeaway messages,” there are several issues of crucial importance. Notably, urine collection in young children who are not yet toilet trained can present considerable challenges in achieving an accurate assessment. A contaminated urine specimen leads to unnecessary antibiotic treatment, and in some cases unwarranted hospitalization, intravenous lines, renal imaging, and follow-up investigations, Dr. Mattoo said.

Ureteral catheterization or suprapubic bladder aspiration are the preferred methods of specimen collection, especially in cases where specimens collected with a perineal bag are dipstick positive, the authors explained. Midstream collection (known as the Quick-Wee method) can also be used following stimulation of the suprapubic area with cold fluid-soaked gauze.

Also of considerable importance is distinguishing bladder infections from kidney infections whenever possible, Dr. Mattoo noted. The antibiotic treatment, complications, and follow-up plans can be different for each, he cautioned. The authors have provided a helpful table within the article to help make this differentiation.
 

Timing is crucial

Prescribing treatment with an antibiotic within 48 hours of fever onset is essential for the prevention of renal scarring, Dr. Mattoo advised. The key is to treat with the goal of avoiding long-term complications. Although there are some exceptions, most cases of UTI can be treated with oral antibiotics and do not require hospitalization.

Some children with first UTI need additional testing, such as renal imaging, to ensure that there are no underlying risk factors for UTI. These children, in particular, can be at an increased risk of recurrent UTI and renal scarring, Dr. Mattoo explained.

Antibiotic resistance is a major emerging problem in patients with UTI at all ages and we should use antibiotics only in patients who truly have a UTI that requires such treatment, he urged.

In an interview, Timothy Joos, MD, a Seattle internist and pediatrician in private practice, noted: “In the words of the British novelist Tom Holt, ‘There are few moments of clarity more profound than those that follow the emptying of an overcharged bladder. The world slows down, the focus sharpens, the brain comes back online. Huge nebulous difficulties prove on close calm examination to be merely cloud giants.’ Thank you to Drs. Mattoo, Nelson, and Shaikh for providing this clarity of current UTI diagnosis and management,” Dr. Joos said.

“It bears repeating that because of the rare prevalence of grade 4 to 5 vesicoureteral reflux in children with their first UTI, current guidelines recommend that a voiding cystourethrogram can be reserved for children with an abnormal ultrasound, atypical pathogen, complicated clinical course, or known renal scarring,” added Dr. Joos.

The authors had no relevant disclosures. Dr. Joos is a member of the Pediatric News editorial advisory board but had no other disclosures.

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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