Platelets for transfusion

Photo from Flickr

Researchers have reported 2 cases in which the Zika virus seems to have been transmitted via platelet transfusion.

Brazilian health officials previously announced 2 cases of Zika virus—in a liver transplant recipient and a gunshot victim—that likely resulted from blood transfusions performed in 2015.

Now, researchers have reported possible transmission via transfusion in 2 more Brazilians—a patient with primary myelofibrosis (PMF) and one with acute myeloid leukemia (AML).

The researchers described these cases in a letter to NEJM.

An individual who donated platelets via apheresis on January 16, 2016, later tested positive for the Zika virus.

On January 19, platelets from that donor were transfused into a 54-year-old woman with PMF and a 14-year-old girl with AML who had also received a haploidentical bone marrow transplant on January 6.

The platelet donor called the blood bank on January 21 to report worrying symptoms—a cutaneous rash, retro-orbital pain, and pain in both knees—that had developed on January 18.

Subsequent testing revealed that the donor was negative for chikungunya and dengue virus. However, both plasma and urine samples tested positive for Zika virus.

Pre-transfusion samples collected from both of the recipients were negative for chikungunya, dengue, and Zika. However, samples collected after the transfusions—6 days after for the woman with PMF and 23 to 51 days after for the girl with AML—tested positive for Zika.

Researchers performed molecular sequencing and phylogenetic analysis of Zika virus RNA isolated from the donor and the recipients. Isolates from all 3 parties had nucleotide changes in the envelope gene (codons 11 and 186) that were not observed among other available isolates from Brazil.

The researchers said these results suggest the platelet transfusions were the source of Zika virus infection in the PMF patient and the AML patient.

Although both patients could have been exposed to Zika-carrying mosquitoes, both the RNA results and the timing of Zika infection suggest the transfusions were the cause.

Platelets for transfusion

Photo from Flickr

Researchers have reported 2 cases in which the Zika virus seems to have been transmitted via platelet transfusion.

Brazilian health officials previously announced 2 cases of Zika virus—in a liver transplant recipient and a gunshot victim—that likely resulted from blood transfusions performed in 2015.

Now, researchers have reported possible transmission via transfusion in 2 more Brazilians—a patient with primary myelofibrosis (PMF) and one with acute myeloid leukemia (AML).

The researchers described these cases in a letter to NEJM.

An individual who donated platelets via apheresis on January 16, 2016, later tested positive for the Zika virus.

On January 19, platelets from that donor were transfused into a 54-year-old woman with PMF and a 14-year-old girl with AML who had also received a haploidentical bone marrow transplant on January 6.

The platelet donor called the blood bank on January 21 to report worrying symptoms—a cutaneous rash, retro-orbital pain, and pain in both knees—that had developed on January 18.

Subsequent testing revealed that the donor was negative for chikungunya and dengue virus. However, both plasma and urine samples tested positive for Zika virus.

Pre-transfusion samples collected from both of the recipients were negative for chikungunya, dengue, and Zika. However, samples collected after the transfusions—6 days after for the woman with PMF and 23 to 51 days after for the girl with AML—tested positive for Zika.

Researchers performed molecular sequencing and phylogenetic analysis of Zika virus RNA isolated from the donor and the recipients. Isolates from all 3 parties had nucleotide changes in the envelope gene (codons 11 and 186) that were not observed among other available isolates from Brazil.

The researchers said these results suggest the platelet transfusions were the source of Zika virus infection in the PMF patient and the AML patient.

Although both patients could have been exposed to Zika-carrying mosquitoes, both the RNA results and the timing of Zika infection suggest the transfusions were the cause.

Platelets for transfusion

Photo from Flickr

Researchers have reported 2 cases in which the Zika virus seems to have been transmitted via platelet transfusion.

Brazilian health officials previously announced 2 cases of Zika virus—in a liver transplant recipient and a gunshot victim—that likely resulted from blood transfusions performed in 2015.

Now, researchers have reported possible transmission via transfusion in 2 more Brazilians—a patient with primary myelofibrosis (PMF) and one with acute myeloid leukemia (AML).

The researchers described these cases in a letter to NEJM.

An individual who donated platelets via apheresis on January 16, 2016, later tested positive for the Zika virus.

On January 19, platelets from that donor were transfused into a 54-year-old woman with PMF and a 14-year-old girl with AML who had also received a haploidentical bone marrow transplant on January 6.

The platelet donor called the blood bank on January 21 to report worrying symptoms—a cutaneous rash, retro-orbital pain, and pain in both knees—that had developed on January 18.

Subsequent testing revealed that the donor was negative for chikungunya and dengue virus. However, both plasma and urine samples tested positive for Zika virus.

Pre-transfusion samples collected from both of the recipients were negative for chikungunya, dengue, and Zika. However, samples collected after the transfusions—6 days after for the woman with PMF and 23 to 51 days after for the girl with AML—tested positive for Zika.

Researchers performed molecular sequencing and phylogenetic analysis of Zika virus RNA isolated from the donor and the recipients. Isolates from all 3 parties had nucleotide changes in the envelope gene (codons 11 and 186) that were not observed among other available isolates from Brazil.

The researchers said these results suggest the platelet transfusions were the source of Zika virus infection in the PMF patient and the AML patient.

Although both patients could have been exposed to Zika-carrying mosquitoes, both the RNA results and the timing of Zika infection suggest the transfusions were the cause.

Pregnant woman

Photo by Nina Matthews

New research suggests expanded prenatal genetic testing may increase the detection of carrier status for potentially serious genetic conditions, including hemoglobinopathies.

Researchers analyzed nearly 350,000 adults of diverse racial and ethnic backgrounds and found evidence to suggest that expanded screening for up to 94 conditions can increase the detection of carrier status when compared with current genetic testing recommendations from professional societies.

Imran S. Haque, PhD, of Counsyl in San Francisco, California, and his colleagues reported these findings in JAMA. The study was funded by Counsyl, a laboratory providing expanded carrier screening.

Genetic testing of prospective parents to detect carriers of specific inherited recessive diseases is part of routine obstetrical practice. The current recommendations are to test for a limited number of individual diseases, in part based on self-reported racial/ethnic background.

Dr Haque and his colleagues wanted to determine if recent advances in genetic testing could facilitate screening for an expanded number of conditions independent of racial/ethnic background.

The researchers analyzed results from expanded carrier screening in 346,790 reproductive-aged individuals, primarily from the US, without known indication for specific genetic testing.

The individuals were tested for carrier status for up to 94 conditions. Tests were offered by clinicians providing reproductive care.

Risk was defined as the probability that a hypothetical fetus created from a random pairing of individuals (within or across 15 self-reported racial/ethnic categories) would be homozygous or compound heterozygous for 2 mutations presumed to cause severe or profound disease.

Severe conditions were defined as those that, if left untreated, cause intellectual disability or a substantially shortened lifespan. Profound conditions were those causing both intellectual disability and a shortened lifespan.

The researchers found that, in most racial/ethnic categories, expanded carrier screening modeled more hypothetical fetuses at risk for severe or profound conditions than did screening based on current professional guidelines.

Overall, relative to expanded carrier screening, guideline-based screening ranged from identifying 6% of hypothetical fetuses affected for East Asian couples to 87% for African or African American couples.

Though this study suggests expanded screening could be beneficial, the researchers said their findings should be confirmed with prospective studies comparing current carrier screening with expanded screening in at-risk populations.

Pregnant woman

Photo by Nina Matthews

New research suggests expanded prenatal genetic testing may increase the detection of carrier status for potentially serious genetic conditions, including hemoglobinopathies.

Researchers analyzed nearly 350,000 adults of diverse racial and ethnic backgrounds and found evidence to suggest that expanded screening for up to 94 conditions can increase the detection of carrier status when compared with current genetic testing recommendations from professional societies.

Imran S. Haque, PhD, of Counsyl in San Francisco, California, and his colleagues reported these findings in JAMA. The study was funded by Counsyl, a laboratory providing expanded carrier screening.

Genetic testing of prospective parents to detect carriers of specific inherited recessive diseases is part of routine obstetrical practice. The current recommendations are to test for a limited number of individual diseases, in part based on self-reported racial/ethnic background.

Dr Haque and his colleagues wanted to determine if recent advances in genetic testing could facilitate screening for an expanded number of conditions independent of racial/ethnic background.

The researchers analyzed results from expanded carrier screening in 346,790 reproductive-aged individuals, primarily from the US, without known indication for specific genetic testing.

The individuals were tested for carrier status for up to 94 conditions. Tests were offered by clinicians providing reproductive care.

Risk was defined as the probability that a hypothetical fetus created from a random pairing of individuals (within or across 15 self-reported racial/ethnic categories) would be homozygous or compound heterozygous for 2 mutations presumed to cause severe or profound disease.

Severe conditions were defined as those that, if left untreated, cause intellectual disability or a substantially shortened lifespan. Profound conditions were those causing both intellectual disability and a shortened lifespan.

The researchers found that, in most racial/ethnic categories, expanded carrier screening modeled more hypothetical fetuses at risk for severe or profound conditions than did screening based on current professional guidelines.

Overall, relative to expanded carrier screening, guideline-based screening ranged from identifying 6% of hypothetical fetuses affected for East Asian couples to 87% for African or African American couples.

Though this study suggests expanded screening could be beneficial, the researchers said their findings should be confirmed with prospective studies comparing current carrier screening with expanded screening in at-risk populations.

Pregnant woman

Photo by Nina Matthews

New research suggests expanded prenatal genetic testing may increase the detection of carrier status for potentially serious genetic conditions, including hemoglobinopathies.

Researchers analyzed nearly 350,000 adults of diverse racial and ethnic backgrounds and found evidence to suggest that expanded screening for up to 94 conditions can increase the detection of carrier status when compared with current genetic testing recommendations from professional societies.

Imran S. Haque, PhD, of Counsyl in San Francisco, California, and his colleagues reported these findings in JAMA. The study was funded by Counsyl, a laboratory providing expanded carrier screening.

Genetic testing of prospective parents to detect carriers of specific inherited recessive diseases is part of routine obstetrical practice. The current recommendations are to test for a limited number of individual diseases, in part based on self-reported racial/ethnic background.

Dr Haque and his colleagues wanted to determine if recent advances in genetic testing could facilitate screening for an expanded number of conditions independent of racial/ethnic background.

The researchers analyzed results from expanded carrier screening in 346,790 reproductive-aged individuals, primarily from the US, without known indication for specific genetic testing.

The individuals were tested for carrier status for up to 94 conditions. Tests were offered by clinicians providing reproductive care.

Risk was defined as the probability that a hypothetical fetus created from a random pairing of individuals (within or across 15 self-reported racial/ethnic categories) would be homozygous or compound heterozygous for 2 mutations presumed to cause severe or profound disease.

Severe conditions were defined as those that, if left untreated, cause intellectual disability or a substantially shortened lifespan. Profound conditions were those causing both intellectual disability and a shortened lifespan.

The researchers found that, in most racial/ethnic categories, expanded carrier screening modeled more hypothetical fetuses at risk for severe or profound conditions than did screening based on current professional guidelines.

Overall, relative to expanded carrier screening, guideline-based screening ranged from identifying 6% of hypothetical fetuses affected for East Asian couples to 87% for African or African American couples.

Though this study suggests expanded screening could be beneficial, the researchers said their findings should be confirmed with prospective studies comparing current carrier screening with expanded screening in at-risk populations.

T cells

Image by NIAID

The European Commission (EC) has granted conditional marketing authorization for an immunogene therapy known as Zalmoxis.

This means Zalmoxis can be marketed in the European Economic Area as an adjunctive therapy to aid immune reconstitution and help treat graft-versus-host disease (GVHD) in adults with high-risk hematologic malignancies who are receiving a haploidentical hematopoietic stem cell transplant (haplo-HSCT).

Zalmoxis consists of allogeneic T cells genetically modified to express both a truncated form of the human low-affinity nerve growth factor receptor (ΔLNGFR), as a cell-surface selectable marker, and the suicide gene herpes simplex I virus thymidine kinase (HSV-TK Mut2).

The modified T cells are given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.

Because the T cells can also cause GVHD, they are equipped with the suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of the disease.

Zalmoxis is being developed by MolMed S.p.A. The company said the treatment should become available in the first European market during the first half of 2017.

About conditional marketing authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Under the provisions of the conditional marketing authorization for Zalmoxis, MolMed will be required to complete a post-marketing study aimed at confirming the clinical benefit of the treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has accepted the ongoing phase 3 TK008 trial as a post-marketing confirmatory study.

Trials of Zalmoxis

The EC’s decision to grant Zalmoxis conditional marketing authorization was based on cumulative efficacy and safety data collected from patients enrolled in a phase 1/2 trial (TK007) and an ongoing phase 3 trial (TK008).

The Zalmoxis group comprised 30 patients from the TK007 trial and 15 patients from the experimental arm of the TK008 trial. The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, and the TK008 trial is enrolling haplo-HSCT recipients with high-risk acute leukemia.

The data thus far have indicated that Zalmoxis can provide rapid immune reconstitution, an anti-leukemia effect, and complete control of GVHD, in the absence of any post-transplant immunosuppression.

Overall, these effects led to a clinically meaningful increase in survival rates in Zalmoxis-treated patients, when compared to historical controls from the European Society for Blood and Marrow Transplantation (EBMT) database.

The only adverse event related to Zalmoxis treatment was GVHD, which was fully resolved by the activation of the suicide gene system with ganciclovir treatment, without any GVHD-related death.

Detailed results of this analysis are set to be presented during the MolMed-sponsored symposium “A new era of haplo-transplantation” at the EBMT International Transplant Course, which is scheduled to take place September 9-11 in Barcelona, Spain.

T cells

Image by NIAID

The European Commission (EC) has granted conditional marketing authorization for an immunogene therapy known as Zalmoxis.

This means Zalmoxis can be marketed in the European Economic Area as an adjunctive therapy to aid immune reconstitution and help treat graft-versus-host disease (GVHD) in adults with high-risk hematologic malignancies who are receiving a haploidentical hematopoietic stem cell transplant (haplo-HSCT).

Zalmoxis consists of allogeneic T cells genetically modified to express both a truncated form of the human low-affinity nerve growth factor receptor (ΔLNGFR), as a cell-surface selectable marker, and the suicide gene herpes simplex I virus thymidine kinase (HSV-TK Mut2).

The modified T cells are given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.

Because the T cells can also cause GVHD, they are equipped with the suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of the disease.

Zalmoxis is being developed by MolMed S.p.A. The company said the treatment should become available in the first European market during the first half of 2017.

About conditional marketing authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Under the provisions of the conditional marketing authorization for Zalmoxis, MolMed will be required to complete a post-marketing study aimed at confirming the clinical benefit of the treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has accepted the ongoing phase 3 TK008 trial as a post-marketing confirmatory study.

Trials of Zalmoxis

The EC’s decision to grant Zalmoxis conditional marketing authorization was based on cumulative efficacy and safety data collected from patients enrolled in a phase 1/2 trial (TK007) and an ongoing phase 3 trial (TK008).

The Zalmoxis group comprised 30 patients from the TK007 trial and 15 patients from the experimental arm of the TK008 trial. The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, and the TK008 trial is enrolling haplo-HSCT recipients with high-risk acute leukemia.

The data thus far have indicated that Zalmoxis can provide rapid immune reconstitution, an anti-leukemia effect, and complete control of GVHD, in the absence of any post-transplant immunosuppression.

Overall, these effects led to a clinically meaningful increase in survival rates in Zalmoxis-treated patients, when compared to historical controls from the European Society for Blood and Marrow Transplantation (EBMT) database.

The only adverse event related to Zalmoxis treatment was GVHD, which was fully resolved by the activation of the suicide gene system with ganciclovir treatment, without any GVHD-related death.

Detailed results of this analysis are set to be presented during the MolMed-sponsored symposium “A new era of haplo-transplantation” at the EBMT International Transplant Course, which is scheduled to take place September 9-11 in Barcelona, Spain.

T cells

Image by NIAID

The European Commission (EC) has granted conditional marketing authorization for an immunogene therapy known as Zalmoxis.

This means Zalmoxis can be marketed in the European Economic Area as an adjunctive therapy to aid immune reconstitution and help treat graft-versus-host disease (GVHD) in adults with high-risk hematologic malignancies who are receiving a haploidentical hematopoietic stem cell transplant (haplo-HSCT).

Zalmoxis consists of allogeneic T cells genetically modified to express both a truncated form of the human low-affinity nerve growth factor receptor (ΔLNGFR), as a cell-surface selectable marker, and the suicide gene herpes simplex I virus thymidine kinase (HSV-TK Mut2).

The modified T cells are given to haplo-HSCT recipients to help fight off infection, enhance the success of the transplant, and support long-lasting anticancer effects.

Because the T cells can also cause GVHD, they are equipped with the suicide gene, which makes them susceptible to treatment with ganciclovir or valganciclovir. So if a patient develops GVHD, he or she can receive ganciclovir/valganciclovir, which should kill the modified T cells and prevent further development of the disease.

Zalmoxis is being developed by MolMed S.p.A. The company said the treatment should become available in the first European market during the first half of 2017.

About conditional marketing authorization

Conditional marketing authorization represents an expedited path for approval. The EC grants this type of authorization before pivotal registration studies are completed.

Conditional marketing authorization is granted to products whose benefits are thought to outweigh their risks, products that address unmet needs, and products that are expected to provide a significant public health benefit.

Under the provisions of the conditional marketing authorization for Zalmoxis, MolMed will be required to complete a post-marketing study aimed at confirming the clinical benefit of the treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has accepted the ongoing phase 3 TK008 trial as a post-marketing confirmatory study.

Trials of Zalmoxis

The EC’s decision to grant Zalmoxis conditional marketing authorization was based on cumulative efficacy and safety data collected from patients enrolled in a phase 1/2 trial (TK007) and an ongoing phase 3 trial (TK008).

The Zalmoxis group comprised 30 patients from the TK007 trial and 15 patients from the experimental arm of the TK008 trial. The TK007 trial included haplo-HSCT recipients with various high-risk hematologic malignancies, and the TK008 trial is enrolling haplo-HSCT recipients with high-risk acute leukemia.

The data thus far have indicated that Zalmoxis can provide rapid immune reconstitution, an anti-leukemia effect, and complete control of GVHD, in the absence of any post-transplant immunosuppression.

Overall, these effects led to a clinically meaningful increase in survival rates in Zalmoxis-treated patients, when compared to historical controls from the European Society for Blood and Marrow Transplantation (EBMT) database.

The only adverse event related to Zalmoxis treatment was GVHD, which was fully resolved by the activation of the suicide gene system with ganciclovir treatment, without any GVHD-related death.

Detailed results of this analysis are set to be presented during the MolMed-sponsored symposium “A new era of haplo-transplantation” at the EBMT International Transplant Course, which is scheduled to take place September 9-11 in Barcelona, Spain.

For patients with recurrent Clostridium difficile infection (CDI), donor stool administered via colonoscopy seemed safe and achieved clinical cure significantly more often than autologous fecal microbiota transplantation (FMT), based on a small trial reported online in Annals of Internal Medicine.

In all, 20 of 22 patients (91%) achieved cure with donor FMT, compared with 63% of patients who received their own markedly dysbiotic stool (P = .04), reported Colleen Kelly, MD, of The Miriam Hospital, Providence, R.I., together with her associates. “Differences in efficacy between sites suggest that some patients with lower risk for CDI recurrence may not benefit from FMT. Further research may help determine the best candidates,” the researchers wrote.

FMT corrects the dysbiosis associated with CDI and is recommended in the event of failed antibiotic therapy leading to a third episode of infection. But this advice is based mainly on case series and open-label trials, the researchers noted. Their dual-center, randomized, controlled, double-blinded study included 46 patients with at least three recurrences of CDI who had completed a course of vancomycin during their most recent episode of infection. Patients older than age 75 years or who were immunocompromised were excluded (Ann Intern Med. 2016 Aug 22. doi: 10.7326/M16-0271).

The overall clinical cure rates reflected the literature, the researchers reported, and all nine patients who developed CDI after autologous FMT were subsequently cured by donor FMT. Indeed, donor FMT “restored normal microbial community structure, with reductions in Proteobacteria and Verrucomicrobia and increases in Bacteroidetes and Firmicutes. In contrast, microbial diversity did not improve after autologous FMT.”

Notably, however, 90% of autologous FMT patients at the center in New York achieved clinical cure, compared with 43% of patients at the center in Rhode Island. Further analyses revealed differences between patients and fecal microbiota at the two sites, the investigators said. Patients in New York typically had CDI for longer, with more recurrences and up to 148 weeks of vancomycin and other antibiotics. Thus, they might have been cured before enrollment. But “autologous FMT patients at the New York site [also] had greater abundances of Clostridia, raising the possibility of emergence of microbial community assemblages inhibitory to C. difficile via competitive niche exclusion, or possibly by emergence of nontoxigenic organisms,” the researchers wrote.

There were no serious adverse effects associated with either type of FMT, they noted.

Dr. Kelly disclosed ties to Seres Health outside the submitted work. Two coauthors had patents or patents pending for “compositions and methods for transplantation of colon microbiota.” A third coauthor disclosed ties to OpenBiome and personal fees from CIPAC/Crestovo outside the submitted work. The remaining coauthors had no conflicts of interest.

For patients with recurrent Clostridium difficile infection (CDI), donor stool administered via colonoscopy seemed safe and achieved clinical cure significantly more often than autologous fecal microbiota transplantation (FMT), based on a small trial reported online in Annals of Internal Medicine.

In all, 20 of 22 patients (91%) achieved cure with donor FMT, compared with 63% of patients who received their own markedly dysbiotic stool (P = .04), reported Colleen Kelly, MD, of The Miriam Hospital, Providence, R.I., together with her associates. “Differences in efficacy between sites suggest that some patients with lower risk for CDI recurrence may not benefit from FMT. Further research may help determine the best candidates,” the researchers wrote.

FMT corrects the dysbiosis associated with CDI and is recommended in the event of failed antibiotic therapy leading to a third episode of infection. But this advice is based mainly on case series and open-label trials, the researchers noted. Their dual-center, randomized, controlled, double-blinded study included 46 patients with at least three recurrences of CDI who had completed a course of vancomycin during their most recent episode of infection. Patients older than age 75 years or who were immunocompromised were excluded (Ann Intern Med. 2016 Aug 22. doi: 10.7326/M16-0271).

The overall clinical cure rates reflected the literature, the researchers reported, and all nine patients who developed CDI after autologous FMT were subsequently cured by donor FMT. Indeed, donor FMT “restored normal microbial community structure, with reductions in Proteobacteria and Verrucomicrobia and increases in Bacteroidetes and Firmicutes. In contrast, microbial diversity did not improve after autologous FMT.”

Notably, however, 90% of autologous FMT patients at the center in New York achieved clinical cure, compared with 43% of patients at the center in Rhode Island. Further analyses revealed differences between patients and fecal microbiota at the two sites, the investigators said. Patients in New York typically had CDI for longer, with more recurrences and up to 148 weeks of vancomycin and other antibiotics. Thus, they might have been cured before enrollment. But “autologous FMT patients at the New York site [also] had greater abundances of Clostridia, raising the possibility of emergence of microbial community assemblages inhibitory to C. difficile via competitive niche exclusion, or possibly by emergence of nontoxigenic organisms,” the researchers wrote.

There were no serious adverse effects associated with either type of FMT, they noted.

Dr. Kelly disclosed ties to Seres Health outside the submitted work. Two coauthors had patents or patents pending for “compositions and methods for transplantation of colon microbiota.” A third coauthor disclosed ties to OpenBiome and personal fees from CIPAC/Crestovo outside the submitted work. The remaining coauthors had no conflicts of interest.

For patients with recurrent Clostridium difficile infection (CDI), donor stool administered via colonoscopy seemed safe and achieved clinical cure significantly more often than autologous fecal microbiota transplantation (FMT), based on a small trial reported online in Annals of Internal Medicine.

In all, 20 of 22 patients (91%) achieved cure with donor FMT, compared with 63% of patients who received their own markedly dysbiotic stool (P = .04), reported Colleen Kelly, MD, of The Miriam Hospital, Providence, R.I., together with her associates. “Differences in efficacy between sites suggest that some patients with lower risk for CDI recurrence may not benefit from FMT. Further research may help determine the best candidates,” the researchers wrote.

FMT corrects the dysbiosis associated with CDI and is recommended in the event of failed antibiotic therapy leading to a third episode of infection. But this advice is based mainly on case series and open-label trials, the researchers noted. Their dual-center, randomized, controlled, double-blinded study included 46 patients with at least three recurrences of CDI who had completed a course of vancomycin during their most recent episode of infection. Patients older than age 75 years or who were immunocompromised were excluded (Ann Intern Med. 2016 Aug 22. doi: 10.7326/M16-0271).

The overall clinical cure rates reflected the literature, the researchers reported, and all nine patients who developed CDI after autologous FMT were subsequently cured by donor FMT. Indeed, donor FMT “restored normal microbial community structure, with reductions in Proteobacteria and Verrucomicrobia and increases in Bacteroidetes and Firmicutes. In contrast, microbial diversity did not improve after autologous FMT.”

Notably, however, 90% of autologous FMT patients at the center in New York achieved clinical cure, compared with 43% of patients at the center in Rhode Island. Further analyses revealed differences between patients and fecal microbiota at the two sites, the investigators said. Patients in New York typically had CDI for longer, with more recurrences and up to 148 weeks of vancomycin and other antibiotics. Thus, they might have been cured before enrollment. But “autologous FMT patients at the New York site [also] had greater abundances of Clostridia, raising the possibility of emergence of microbial community assemblages inhibitory to C. difficile via competitive niche exclusion, or possibly by emergence of nontoxigenic organisms,” the researchers wrote.

There were no serious adverse effects associated with either type of FMT, they noted.

Dr. Kelly disclosed ties to Seres Health outside the submitted work. Two coauthors had patents or patents pending for “compositions and methods for transplantation of colon microbiota.” A third coauthor disclosed ties to OpenBiome and personal fees from CIPAC/Crestovo outside the submitted work. The remaining coauthors had no conflicts of interest.

Breast density is an important factor in determining the appropriate screening intervals for mammography after age 50 years, according to a report published online Aug. 22 in Annals of Internal Medicine.

Researchers from the Cancer Intervention and Surveillance Modeling Network, collaborating with the Breast Cancer Surveillance Consortium, assessed three separate, well-established microsimulation models that used different structures and underlying assumptions but the same data input to estimate the benefits and harms of various screening intervals. They applied the models to two hypothetical populations: Women aged 50 years and older who were initiating screening for the first time and women aged 65 years who had undergone biennial screening since age 50 years.

Catherine Yeulet/©Thinkstock

The models incorporated national data regarding breast cancer incidence, treatment efficacy, and survival. They assessed patient risk by including numerous factors, such as menopausal status, obesity status, age at menarche, nulliparity, and previous biopsy results, but didn’t include family history or genetic testing results. Screening strategies were compared among four possible breast-density levels, according to the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS).

The principal finding was that two factors – breast density and risk for breast cancer – were key to determining the optimal screening interval. The optimal interval was the one that would yield the highest number of benefits (breast cancer deaths averted, life-years gained, and quality-adjusted life-years gained) while yielding the lowest number of harms (false-positive mammograms, benign biopsies, and overdiagnosis).

“For average-risk women in low-density subgroups, who comprise a large portion of the population, triennial screening provides a reasonable balance of benefits and harms and is cost effective. Annual screening has a favorable balance of benefits and harms and would be considered cost effective for subgroups of women ... with risk levels that are two to four times the average and with heterogeneously or extremely dense breasts,” the researchers wrote (Ann.Intern Med. 2016 Aug 22. doi: 10.7326/M16-0476).

After age 50 years, annual mammography was more beneficial than harmful only in two subgroups of women: those with greater breast density and those with higher risk for breast cancer. Such women are estimated to comprise less than 1% of the general population at both age 50 years and age 65 years. In contrast, biennial and even triennial mammography yielded fewer false-positives and fewer biopsies for average-risk women with low-density breasts without affecting the number of breast cancer deaths averted, the researchers noted.

The study was supported by grants from the National Institutes of Health and several state public health departments and cancer registries in the United States. The researchers reported receiving grants and other support from the NIH, the American Society of Breast Surgeons, Renaissance Rx, Ally Clinical Diagnostics, the Netherlands National Institute for Public Health and the Environment, SCOR Global Risk Center, and Genomic Health Canada.

Breast density is an important factor in determining the appropriate screening intervals for mammography after age 50 years, according to a report published online Aug. 22 in Annals of Internal Medicine.

Researchers from the Cancer Intervention and Surveillance Modeling Network, collaborating with the Breast Cancer Surveillance Consortium, assessed three separate, well-established microsimulation models that used different structures and underlying assumptions but the same data input to estimate the benefits and harms of various screening intervals. They applied the models to two hypothetical populations: Women aged 50 years and older who were initiating screening for the first time and women aged 65 years who had undergone biennial screening since age 50 years.

Catherine Yeulet/©Thinkstock

The models incorporated national data regarding breast cancer incidence, treatment efficacy, and survival. They assessed patient risk by including numerous factors, such as menopausal status, obesity status, age at menarche, nulliparity, and previous biopsy results, but didn’t include family history or genetic testing results. Screening strategies were compared among four possible breast-density levels, according to the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS).

The principal finding was that two factors – breast density and risk for breast cancer – were key to determining the optimal screening interval. The optimal interval was the one that would yield the highest number of benefits (breast cancer deaths averted, life-years gained, and quality-adjusted life-years gained) while yielding the lowest number of harms (false-positive mammograms, benign biopsies, and overdiagnosis).

“For average-risk women in low-density subgroups, who comprise a large portion of the population, triennial screening provides a reasonable balance of benefits and harms and is cost effective. Annual screening has a favorable balance of benefits and harms and would be considered cost effective for subgroups of women ... with risk levels that are two to four times the average and with heterogeneously or extremely dense breasts,” the researchers wrote (Ann.Intern Med. 2016 Aug 22. doi: 10.7326/M16-0476).

After age 50 years, annual mammography was more beneficial than harmful only in two subgroups of women: those with greater breast density and those with higher risk for breast cancer. Such women are estimated to comprise less than 1% of the general population at both age 50 years and age 65 years. In contrast, biennial and even triennial mammography yielded fewer false-positives and fewer biopsies for average-risk women with low-density breasts without affecting the number of breast cancer deaths averted, the researchers noted.

The study was supported by grants from the National Institutes of Health and several state public health departments and cancer registries in the United States. The researchers reported receiving grants and other support from the NIH, the American Society of Breast Surgeons, Renaissance Rx, Ally Clinical Diagnostics, the Netherlands National Institute for Public Health and the Environment, SCOR Global Risk Center, and Genomic Health Canada.

Breast density is an important factor in determining the appropriate screening intervals for mammography after age 50 years, according to a report published online Aug. 22 in Annals of Internal Medicine.

Researchers from the Cancer Intervention and Surveillance Modeling Network, collaborating with the Breast Cancer Surveillance Consortium, assessed three separate, well-established microsimulation models that used different structures and underlying assumptions but the same data input to estimate the benefits and harms of various screening intervals. They applied the models to two hypothetical populations: Women aged 50 years and older who were initiating screening for the first time and women aged 65 years who had undergone biennial screening since age 50 years.

Catherine Yeulet/©Thinkstock

The models incorporated national data regarding breast cancer incidence, treatment efficacy, and survival. They assessed patient risk by including numerous factors, such as menopausal status, obesity status, age at menarche, nulliparity, and previous biopsy results, but didn’t include family history or genetic testing results. Screening strategies were compared among four possible breast-density levels, according to the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS).

The principal finding was that two factors – breast density and risk for breast cancer – were key to determining the optimal screening interval. The optimal interval was the one that would yield the highest number of benefits (breast cancer deaths averted, life-years gained, and quality-adjusted life-years gained) while yielding the lowest number of harms (false-positive mammograms, benign biopsies, and overdiagnosis).

“For average-risk women in low-density subgroups, who comprise a large portion of the population, triennial screening provides a reasonable balance of benefits and harms and is cost effective. Annual screening has a favorable balance of benefits and harms and would be considered cost effective for subgroups of women ... with risk levels that are two to four times the average and with heterogeneously or extremely dense breasts,” the researchers wrote (Ann.Intern Med. 2016 Aug 22. doi: 10.7326/M16-0476).

After age 50 years, annual mammography was more beneficial than harmful only in two subgroups of women: those with greater breast density and those with higher risk for breast cancer. Such women are estimated to comprise less than 1% of the general population at both age 50 years and age 65 years. In contrast, biennial and even triennial mammography yielded fewer false-positives and fewer biopsies for average-risk women with low-density breasts without affecting the number of breast cancer deaths averted, the researchers noted.

The study was supported by grants from the National Institutes of Health and several state public health departments and cancer registries in the United States. The researchers reported receiving grants and other support from the NIH, the American Society of Breast Surgeons, Renaissance Rx, Ally Clinical Diagnostics, the Netherlands National Institute for Public Health and the Environment, SCOR Global Risk Center, and Genomic Health Canada.

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].

The struggles with the State of Ohio Board of Pharmacy continue. The pharmacy board reopened its comment period for 2 weeks and received many comments from multiple physicians, organizations, and patients who would be adversely affected by the Board’s move to hold physicians’ offices to the same standard as compounding pharmacies. This was the topic of my recent column, in which I pointed out that as a result, “any practitioners who reconstitute any drug in their offices is considered to be a compounding pharmacy, ordered to pay compounding pharmacy registration fees ($112 yearly), and to undergo the same inspections as compounding pharmacies”.

At their last meeting, the pharmacy board members made a few minor changes, but practitioners will still have to throw out their neurotoxins after 1-6 hours (the exact time is still under debate). Incidentally, I have spoken to all three neurotoxin manufacturers, and they have no interest in adding preservative to their products or in bringing out smaller unit dose packaging. These regulations will have broad impact across the house of medicine because many specialties use neurotoxin.

You should know the back story behind all of this, and how the house of medicine came to this sad place.

About 20 years ago, pain control became a cause célèbre in medicine championed by no less than the World Health Organization. Numerous publications, thought leaders, and policy wonks decried the inadequacy of pain control both in and out of the hospital. It was explained loud and long that patients should have their pain controlled and that physicians fell short if they did not do so, never mind that there is no quantifiable way to measure pain. Further, it was explained that patients in severe pain did not become addicted to narcotics. And the Joint Commission heralded pain control as “the fifth vital sign.”

Where are these thought leaders now?

Graded on responsiveness to patients’ pain and the results of patient surveys on pain control, physicians grudgingly opened the narcotic floodgates and large quantities of prescription narcotics hit the streets. Admittedly, some were written by bad doctors running “pill mills,” but other supplies were diverted by producers, pharmacists, pharmacies, and pharmacy technicians. Hundreds of thousands of Americans became addicted to prescription narcotics, but overdoses were infrequent because there was a unit dose on the street.

Then the medical pendulum swung back, and it was decided that there was too much pain medicine on the streets. The narcotic supply spigots were tightened sharply by the Drug Enforcement Administration, medical boards, and legislatures. It became hard for drug-seeking patients to fill multiple prescriptions, pill mills were shut down, doctors were encouraged to prescribe minimum dosages of narcotic pain relievers, and the price of the unit dose shot up on the street. The patterns of abuse and addiction shifted as heroin became cheaper and more readily available, but hard to dose, particularly when Mexican fentanyl was being sold as “heroin.” Unable to judge the dose of illicitly obtained drugs, addicts began overdosing and dying all over America.

Angry, bereaved family members demanded an accounting for the addiction and deaths of their relatives. Heat was applied to politicians, and a “culprit” was found, physicians! Physicians had made these drugs available and caused all of these people to be addicted!

And thus began the political ascendancy of the pharmacy board, whose members claimed clean hands in this affair. Keen to expand their scope of practice, pharmacists have been trying to find a way into clinical medicine for years. The pharmacy board offered their expertise, and politicians angry at doctors were willing to give the pharmacists’ recommendations a try.

Last year in Ohio, the legislature passed a huge budget reconciliation bill with language tucked in it that authorized the pharmacy board to regulate buprenorphine and other dangerous drugs. The obvious reading of this authority would be that pharmacists were supposed to regulate compounding pharmacies, like the one that produced tainted steroid injections that resulted in 64 deaths in 2012.The regulation is so vague, however, that it could be construed that pharmacists were supposed to regulate everyone in the state, especially since the pharmacy board unilaterally moved to define “dangerous” as any prescription drug. This puts all of medicine in play. The board then declared that it would apply U.S. Pharmacopeial Convention standards (those used for compounding pharmacies) to all physician offices and declared that reconstitution of any drug is considered to be compounding.

To consider physician’s offices as compounding pharmacies is absurd and will degrade patient care by increasing expense and denying access to treatments. Physicians have made and applied individual customized medications to their patients since Galen. It is an integral part of the practice of medicine and has not suddenly become the practice of pharmacy. Using this logic, pharmacists, who have recently won the right to administer vaccinations, should obtain special licenses from the state medical board, since injecting medications is clearly in the purview of medical practice. Physicians have not been killing patients by running dirty compounding pharmacies, pharmacists have. Good, clean up the compounding pharmacies! But applying these compounding rules to physicians’ offices will not save any lives.

This battle has just been joined. The American Medical Association recently passed a resolution declaring that physician compounding should be regulated by state medical boards. This action is most helpful, and another reason for you to join and support the AMA. If you practice in Ohio, you should join the Ohio State Medical Association post haste. They are a big dog in the Ohio legislature, and your membership will influence their efforts.

I hope the Ohio governor’s Common Sense Initiative Office will convene a joint meeting that allows physicians, especially dermatologists, to demonstrate the absurdity of these rules, and their potentially destructive effects on patient care. However, I do not expect the pharmacy board to readily give up this power. Ultimately, the language in the legislative code must add two words after the word “compounding.” The words to be added are “by pharmacists.”

These rules may have to be stayed by a legal injunction. If the legislation is not clarified, a lawsuit against the pharmacy board based on restraint of trade should be successful.

Be vigilant, and watch your state legislatures. Just recently, the pharmacy board of North Dakota has made the same power grab. Stay tuned, as this struggle has national implications.

Dr. Coldiron is past president of the American Academy of Dermatology. He is currently in private practice, but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. Write to him at [email protected].

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. Creative young investigators are poised to make groundbreaking discoveries that will shape the future of gastroenterology. As the charitable arm of the AGA, the AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career.

“To continue to improve the diagnosis and treatment of digestive disease, we need innovative researchers with new approaches. This kind of scientific exploration has the potential to make a tremendous impact on the future of health care,” states Dr. Robert S. Sandler, chair of the AGA Research Foundation and AGA Legacy Society member.

By joining others in supporting the AGA Research Foundation, you will ensure that young investigators have opportunities to continue their life-saving work. Learn more or make a contribution at the AGA Research Foundation web site.

Join the AGA Legacy Society

The AGA Legacy Society honors individuals who have chosen to benefit the AGA Research Foundation through a significant current or planned gift. Research is made possible through their support. AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back. Members of the AGA Legacy Society contribute $5,000 or more annually for five years to the AGA Research Foundation. Learn more about the AGA Legacy Society on the foundation’s website.

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. Creative young investigators are poised to make groundbreaking discoveries that will shape the future of gastroenterology. As the charitable arm of the AGA, the AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career.

“To continue to improve the diagnosis and treatment of digestive disease, we need innovative researchers with new approaches. This kind of scientific exploration has the potential to make a tremendous impact on the future of health care,” states Dr. Robert S. Sandler, chair of the AGA Research Foundation and AGA Legacy Society member.

By joining others in supporting the AGA Research Foundation, you will ensure that young investigators have opportunities to continue their life-saving work. Learn more or make a contribution at the AGA Research Foundation web site.

Join the AGA Legacy Society

The AGA Legacy Society honors individuals who have chosen to benefit the AGA Research Foundation through a significant current or planned gift. Research is made possible through their support. AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back. Members of the AGA Legacy Society contribute $5,000 or more annually for five years to the AGA Research Foundation. Learn more about the AGA Legacy Society on the foundation’s website.

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field – clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. Creative young investigators are poised to make groundbreaking discoveries that will shape the future of gastroenterology. As the charitable arm of the AGA, the AGA Research Foundation provides a key source of funding at a critical juncture in a young researcher’s career.

“To continue to improve the diagnosis and treatment of digestive disease, we need innovative researchers with new approaches. This kind of scientific exploration has the potential to make a tremendous impact on the future of health care,” states Dr. Robert S. Sandler, chair of the AGA Research Foundation and AGA Legacy Society member.

By joining others in supporting the AGA Research Foundation, you will ensure that young investigators have opportunities to continue their life-saving work. Learn more or make a contribution at the AGA Research Foundation web site.

Join the AGA Legacy Society

The AGA Legacy Society honors individuals who have chosen to benefit the AGA Research Foundation through a significant current or planned gift. Research is made possible through their support. AGA Legacy Society members are showing their gratitude for what funding and research has brought to our specialty by giving back. Members of the AGA Legacy Society contribute $5,000 or more annually for five years to the AGA Research Foundation. Learn more about the AGA Legacy Society on the foundation’s website.

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Avoid weight-based language, use motivational interviewing techniques, and promote healthy family-based lifestyle modifications to prevent and manage obesity without predisposing adolescents to eating disorders, according to new recommendations in an American Academy of Pediatrics clinical report.

Obesity and eating disorders are becoming increasingly prevalent in adolescents. In 2012, 20.5% of 12- to 19-year-olds met sex-specific body mass index (BMI) criteria for obesity, according to data from the National Health and Nutrition Examination survey. From 1999 to 2006, there was a 119% increase in hospitalizations due to eating disorders among children younger than 12 years, according to a 2011 study by the Agency for Healthcare Research and Quality.

©moodboard/thinkstockphotos.com

Most adolescents who develop eating disorders are not obese, lead coauthor Neville H. Golden, MD, of Stanford (Calif.) University and his associates noted in the report by the AAP Committee on Nutrition, the Committee on Adolescence, and the Section on Obesity (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-1649).

However, in some adolescents, obesity prevention or management and initial attempts to lose weight can spiral into the development of an eating disorder, they said. “In one study in adolescents seeking treatment of an [eating disorder], 36.7% had a previous weight greater than the 85th percentile for age and sex.”

Cross-sectional and longitudinal observational studies identified dieting, body dissatisfaction, and talking about or teasing a child about his or her weight as risk factors for obesity and eating disorders. Conversely, family meals have been associated with improved dietary quality and a reduction in eating disorders among adolescent girls.

As pediatricians are often the first professional consulted by a parent when eating disorders or obesity are a concern, the investigators recommended the following office-based, evidence-informed tools to provide guidance about obesity and eating disorders:

• Discourage dieting, skipping of meals, or the use of diet pills.

• Encourage healthy eating and physical activity.

• Promote a positive body image; do not focus on body dissatisfaction as a reason for dieting.

• Encourage family meals.

• Encourage families not to talk about weight, but rather to talk about healthy eating and being active to stay healthy.

• Inquire about a history of mistreatment or bullying in overweight and obese teenagers and address this issue with patients and their families.

• Monitor weight loss in adolescents who need to lose weight.

The American Academy of Pediatrics supported this clinical report. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

In preparation for a presentation at the 58th Annual Meeting of the Noah Worcester Dermatological Society (April 6-10, 2016; Marana, Arizona) entitled “Burnout: The New Epidemic,” I sent out a brief survey with 4 questions, one of which asked what changes members planned to make to deal with burnout symptoms. I offered the following list of possibilities: retire early, go to more dermatology meetings, work fewer hours, see fewer patients, change jobs, leave dermatology, leave the profession of medicine altogether, restrict practice to previous patients, restrict patients to certain types of insurances only, restrict practice to self-pay patients only, and hire additional help. One of my colleagues tested the survey and suggested that I add both practicing mindfulness at work and volunteering in underprivileged settings. Mindfulness? Interesting, but it seemed unlikely that anyone would select that answer. Needing some filler answers, I added both to the list on the final survey.

Burnout is defined by episodes of emotional fatigue; development of a negative, callous, or cynical attitude toward patients; and a decreased sense of personal accomplishment.¹ Survey responses showed that 58% of 48 respondents indicated that they experienced a symptom of burnout and stated that their primary issues were helplessness in the ability to shape their role or their practice, difficulty in obtaining medications that they prescribed for their patients, and too many hours at work. What did they choose as their primary actions to deal with burnout? Forty-two percent of respondents said they would work fewer hours, 38% said they would retire early, and a startling 35% said they would practice mindfulness at work.² Because one-third of these practicing dermatologists thought they would find value in practicing mindfulness, I decided to explore this topic for its relevance in our work lives.

Mindfulness is a purposeful activity that involves being acutely aware of what is happening now as opposed to thinking about the past or worrying about the future. Jon Kabat-Zinn, PhD, developer of the practice called mindfulness-based stress reduction, phrases it this way: “Mindfulness is awareness, cultivated by paying attention in a sustained and particular way: on purpose, in the present moment, and non-judgmentally.”³ It is being rather than becoming; it is noticing internal experiences and external events rather than reacting; and it is intentional, not accidental.

Mindfulness practices include meditation, yoga, and tai chi. Buddhist monks listen to bells chime, Sufis spin by putting one foot in front of the other, and fly fishermen watch the ripples in the river. My son, a jazz musician, gets into the zone playing his bass and even senses color changes while completely losing track of time and space. I enjoy walking with my camera, looking intently for little things in the right light that will make interesting photographs. Then, I work on the right framing for that view before I take the photograph. The process keeps me in the moment, visually appreciating what I see, with no room for anxiety about my long must-do list.

Is mindfulness relevant to our work lives? The Boston Globe highlighted how mindfulness has become mainstream, reporting that major companies including Google, Aetna, the Huffington Post, Eileen Fisher, and the Massachusetts General Hospital build in opportunities during the work day for an employee to utilize practices that promote mindfulness.⁴ In the corporate setting, the stated objective is to contribute to the well-being of the employee, but the major motivation by the company is to reduce stress, which is one of the most costly employee health issues for absenteeism, turnover, and diminished creativity and productivity.

The medical literature supports the worth of mindfulness practices. A study of Brazilian primary care professionals showed a strong negative correlation between mindfulness and perceived stress.⁵ Irving et al⁶ showed that an 8-week formal mindfulness program reduced stress in health care professionals and produced remarkable evidence of better physical and mental health. In Australia, where medical students have much higher levels of depression and anxiety compared to the general adult population, medical students with higher levels of mindfulness traits, especially the nonjudgmental subscale, had lower levels of distress.⁷ Shapiro et al⁸ found notable decreases in distress for medical students who participated in a mindfulness program.

And mindfulness matters to patient care. A multicenter observational study of 45 clinicians caring for patients with human immunodeficiency virus found that clinicians with the highest mindfulness scores displayed a more positive emotional tone with patients and their patients reported higher ratings on clinician communication. The researchers hypothesized that these better clinical interactions may have a profound effect on quality, safety, and efficacy of the patient’s care.⁹

How can we incorporate mindfulness in our daily work lives? For some it is a cognitive style that regularly facilitates nonjudgmental awareness, but there are regular practices that induce mindfulness as temporary states and help build it as a persistent style. A common exercise is to take a raisin, hold it in your hand and appreciate its color and shape, roll it in between your fingers for a tactile sensation that you describe in words to yourself, then put it on your tongue to feel its sensation there, and finally chew it noticing the texture and the taste. Another practice has been highlighted by respected Buddhist monk Thich Nhat Hanh who reminds us to concentrate on our breath, observing what happens as we breathe in and out.¹⁰ Kabat-Zinn³ challenges us to “hear what is here to be heard. . . . letting sounds arrive at our door, letting them come to us.” He points out it is relatively easy to be intently aware of the external and physical world, but the real difficulty is being aware and examining our thoughts and internal experiences without being drawn into judging them, which then leads us to be carried away on an emotional path.³

When I am preoccupied or distracted at work, I find it helpful to stop at the door I am about to enter, hold the knob, and take a deep breath, concentrating on the next single task in front of me. Then I open the door and see a patient or deal with an administrative issue. My mindfulness in action at the workplace, helping me have a good and productive day. Yes, mindfulness is relevant to our work lives.

The total metabolic tumor volume, as quantified on PET scanning at the time that follicular lymphoma is diagnosed, is a strong independent predictor of treatment response and patient outcome, according to a report published online in Journal of Clinical Oncology.

Until now, no study has specifically examined the prognostic possibilities of PET-derived total metabolic tumor volume (TMTV) for this malignancy, either on its own or in combination with any of several existing prognostic indices. Those tools use a variety of surrogates to estimate tumor burden. Now that PET is recommended at diagnosis for all cases of follicular lymphoma and anatomic CT data are also available, it is much easier to estimate total tumor burden than it was when those indices were developed, said Michel Meignan, MD, PhD, of Hôpital Henri Mondor, Crétiel (France) and his associates.

It is crucial to identify patients likely to have a poor response to standard treatment, both to spare them the considerable adverse effects of that treatment and to select them for alternative first-line approaches. Even though patient survival has improved markedly during the past decade with the introduction of combined treatment using rituximab plus chemotherapy, approximately 20% of patients still show disease progression within 2 years, and the 5-year overall survival is only 50%, the investigators noted.

To assess the prognostic value of TMTV as assessed by PET, they pooled data from three multicenter prospective studies involving 185 patients with either a high tumor burden or advanced-stage follicular lymphoma. These participants were followed for a median of 63.5 months at 56 medical centers in France, Belgium, Australia, and Italy.

A TMTV threshold of 510 cm³ was found to have the optimal sensitivity (0.46), specificity (0.83), positive predictive value (0.67), and negative predictive value (0.67) for predicting both progression-free and overall survival. The 30% of patients who had a TMTV greater than that cutoff point had markedly inferior 5-year progression-free survival (less than 3 years), while the 70% who had a smaller TMTV had median progression-free survival of more than 6 years, Dr. Meignan and his associates said (J Clin Oncol. 2016 Aug 22. doi:10.1200/JCO.2016.66.9440).

Combining TMTV with other prognostic measures improved predictions even further. Patients who had both a high TMTV and an intermediate to high score on the Follicular Lymphoma International Prognostic Index 2 showed extremely poor outcomes, with a median progression-free survival of only 19 months. “This population can no longer be characterized as having an indolent lymphoma,” the investigators said.

No sponsor or funding source was cited for this study. Dr. Meignan reported receiving fees for travel and expenses from Roche; his associates reported ties to numerous industry sources.

The total metabolic tumor volume, as quantified on PET scanning at the time that follicular lymphoma is diagnosed, is a strong independent predictor of treatment response and patient outcome, according to a report published online in Journal of Clinical Oncology.

Until now, no study has specifically examined the prognostic possibilities of PET-derived total metabolic tumor volume (TMTV) for this malignancy, either on its own or in combination with any of several existing prognostic indices. Those tools use a variety of surrogates to estimate tumor burden. Now that PET is recommended at diagnosis for all cases of follicular lymphoma and anatomic CT data are also available, it is much easier to estimate total tumor burden than it was when those indices were developed, said Michel Meignan, MD, PhD, of Hôpital Henri Mondor, Crétiel (France) and his associates.

It is crucial to identify patients likely to have a poor response to standard treatment, both to spare them the considerable adverse effects of that treatment and to select them for alternative first-line approaches. Even though patient survival has improved markedly during the past decade with the introduction of combined treatment using rituximab plus chemotherapy, approximately 20% of patients still show disease progression within 2 years, and the 5-year overall survival is only 50%, the investigators noted.

To assess the prognostic value of TMTV as assessed by PET, they pooled data from three multicenter prospective studies involving 185 patients with either a high tumor burden or advanced-stage follicular lymphoma. These participants were followed for a median of 63.5 months at 56 medical centers in France, Belgium, Australia, and Italy.

A TMTV threshold of 510 cm³ was found to have the optimal sensitivity (0.46), specificity (0.83), positive predictive value (0.67), and negative predictive value (0.67) for predicting both progression-free and overall survival. The 30% of patients who had a TMTV greater than that cutoff point had markedly inferior 5-year progression-free survival (less than 3 years), while the 70% who had a smaller TMTV had median progression-free survival of more than 6 years, Dr. Meignan and his associates said (J Clin Oncol. 2016 Aug 22. doi:10.1200/JCO.2016.66.9440).

Combining TMTV with other prognostic measures improved predictions even further. Patients who had both a high TMTV and an intermediate to high score on the Follicular Lymphoma International Prognostic Index 2 showed extremely poor outcomes, with a median progression-free survival of only 19 months. “This population can no longer be characterized as having an indolent lymphoma,” the investigators said.

No sponsor or funding source was cited for this study. Dr. Meignan reported receiving fees for travel and expenses from Roche; his associates reported ties to numerous industry sources.

The total metabolic tumor volume, as quantified on PET scanning at the time that follicular lymphoma is diagnosed, is a strong independent predictor of treatment response and patient outcome, according to a report published online in Journal of Clinical Oncology.

Until now, no study has specifically examined the prognostic possibilities of PET-derived total metabolic tumor volume (TMTV) for this malignancy, either on its own or in combination with any of several existing prognostic indices. Those tools use a variety of surrogates to estimate tumor burden. Now that PET is recommended at diagnosis for all cases of follicular lymphoma and anatomic CT data are also available, it is much easier to estimate total tumor burden than it was when those indices were developed, said Michel Meignan, MD, PhD, of Hôpital Henri Mondor, Crétiel (France) and his associates.

It is crucial to identify patients likely to have a poor response to standard treatment, both to spare them the considerable adverse effects of that treatment and to select them for alternative first-line approaches. Even though patient survival has improved markedly during the past decade with the introduction of combined treatment using rituximab plus chemotherapy, approximately 20% of patients still show disease progression within 2 years, and the 5-year overall survival is only 50%, the investigators noted.

To assess the prognostic value of TMTV as assessed by PET, they pooled data from three multicenter prospective studies involving 185 patients with either a high tumor burden or advanced-stage follicular lymphoma. These participants were followed for a median of 63.5 months at 56 medical centers in France, Belgium, Australia, and Italy.

A TMTV threshold of 510 cm³ was found to have the optimal sensitivity (0.46), specificity (0.83), positive predictive value (0.67), and negative predictive value (0.67) for predicting both progression-free and overall survival. The 30% of patients who had a TMTV greater than that cutoff point had markedly inferior 5-year progression-free survival (less than 3 years), while the 70% who had a smaller TMTV had median progression-free survival of more than 6 years, Dr. Meignan and his associates said (J Clin Oncol. 2016 Aug 22. doi:10.1200/JCO.2016.66.9440).

Combining TMTV with other prognostic measures improved predictions even further. Patients who had both a high TMTV and an intermediate to high score on the Follicular Lymphoma International Prognostic Index 2 showed extremely poor outcomes, with a median progression-free survival of only 19 months. “This population can no longer be characterized as having an indolent lymphoma,” the investigators said.

No sponsor or funding source was cited for this study. Dr. Meignan reported receiving fees for travel and expenses from Roche; his associates reported ties to numerous industry sources.