Photo by Steven Harbour

The US Food and Drug Administration (FDA) has released a list of companies that “may be pursuing gaming tactics to delay generic competition.”

FDA Commissioner Scott Gottlieb, MD, said the agency is taking steps to improve access to drugs and make them more affordable.

One of these steps is trying to prevent companies that market brand-name drugs from delaying the release of generic equivalents.

Dr Gottlieb explained that brand companies may create obstacles for generic developers to purchase samples of a brand-name drug.

“In general, generic drug developers need the samples of the brand drug to develop their generic product and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval,” he said.

“Without these samples, generic drug makers may not be able to develop generic alternatives. Yet the FDA has heard that some brand companies will adopt tactics to make it hard for the generic companies to purchase these brand drugs at a fair value and in the open marketplace.”

One such tactic is for brand companies to place restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers, or specialty pharmacies that limit their ability to sell samples to generic drug developers.

In other cases, brand companies may be preventing generic drug developers from accessing samples due to limited distribution programs required by a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU).

“But I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Dr Gottlieb said. “Even in the case of limited distribution programs, such as those required by certain REMS, there should be a path forward for generic drug development.”

With this in mind, the FDA has released a list of brand companies that may have prevented generic drug developers from accessing samples. The list contains 52 brand-name drugs, including Pomalyst, Promacta, Revlimid, Tasigna, and Thalidomid.

Generic drug developers have reported trouble obtaining samples of these drugs and asked the FDA for assistance.

When the FDA receives such a request, the agency first determines whether the product in question has a REMS program with ETASU that may impact distribution.

If the FDA confirms the existence of such a program, the generic company can submit its bioequivalence testing protocol to the FDA. The agency then evaluates this protocol to ensure the plan for testing the product contains safety protections comparable to the brand product’s REMS program.

If a generic developer’s plans include appropriate protections, the developer can request that the FDA send a Safety Determination Letter to the brand company. This letter notes that the REMS program doesn’t prevent the brand company from selling its product to generic drug developers.

The FDA has issued 21 Safety Determination Letters to date, according to Dr Gottlieb.

If a generic drug developer has trouble obtaining samples of a drug for which there is no REMS program with ETASU, the FDA informs the developer that there are no FDA-required restrictions that would prevent it from obtaining samples.

The FDA also notifies the Federal Trade Commission (FTC) of requests from generic drug developers seeking assistance in obtaining samples from brand companies. And the FDA encourages generic drug developers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place.

Photo by Steven Harbour

The US Food and Drug Administration (FDA) has released a list of companies that “may be pursuing gaming tactics to delay generic competition.”

FDA Commissioner Scott Gottlieb, MD, said the agency is taking steps to improve access to drugs and make them more affordable.

One of these steps is trying to prevent companies that market brand-name drugs from delaying the release of generic equivalents.

Dr Gottlieb explained that brand companies may create obstacles for generic developers to purchase samples of a brand-name drug.

“In general, generic drug developers need the samples of the brand drug to develop their generic product and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval,” he said.

“Without these samples, generic drug makers may not be able to develop generic alternatives. Yet the FDA has heard that some brand companies will adopt tactics to make it hard for the generic companies to purchase these brand drugs at a fair value and in the open marketplace.”

One such tactic is for brand companies to place restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers, or specialty pharmacies that limit their ability to sell samples to generic drug developers.

In other cases, brand companies may be preventing generic drug developers from accessing samples due to limited distribution programs required by a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU).

“But I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Dr Gottlieb said. “Even in the case of limited distribution programs, such as those required by certain REMS, there should be a path forward for generic drug development.”

With this in mind, the FDA has released a list of brand companies that may have prevented generic drug developers from accessing samples. The list contains 52 brand-name drugs, including Pomalyst, Promacta, Revlimid, Tasigna, and Thalidomid.

Generic drug developers have reported trouble obtaining samples of these drugs and asked the FDA for assistance.

When the FDA receives such a request, the agency first determines whether the product in question has a REMS program with ETASU that may impact distribution.

If the FDA confirms the existence of such a program, the generic company can submit its bioequivalence testing protocol to the FDA. The agency then evaluates this protocol to ensure the plan for testing the product contains safety protections comparable to the brand product’s REMS program.

If a generic developer’s plans include appropriate protections, the developer can request that the FDA send a Safety Determination Letter to the brand company. This letter notes that the REMS program doesn’t prevent the brand company from selling its product to generic drug developers.

The FDA has issued 21 Safety Determination Letters to date, according to Dr Gottlieb.

If a generic drug developer has trouble obtaining samples of a drug for which there is no REMS program with ETASU, the FDA informs the developer that there are no FDA-required restrictions that would prevent it from obtaining samples.

The FDA also notifies the Federal Trade Commission (FTC) of requests from generic drug developers seeking assistance in obtaining samples from brand companies. And the FDA encourages generic drug developers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place.

Photo by Steven Harbour

The US Food and Drug Administration (FDA) has released a list of companies that “may be pursuing gaming tactics to delay generic competition.”

FDA Commissioner Scott Gottlieb, MD, said the agency is taking steps to improve access to drugs and make them more affordable.

One of these steps is trying to prevent companies that market brand-name drugs from delaying the release of generic equivalents.

Dr Gottlieb explained that brand companies may create obstacles for generic developers to purchase samples of a brand-name drug.

“In general, generic drug developers need the samples of the brand drug to develop their generic product and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval,” he said.

“Without these samples, generic drug makers may not be able to develop generic alternatives. Yet the FDA has heard that some brand companies will adopt tactics to make it hard for the generic companies to purchase these brand drugs at a fair value and in the open marketplace.”

One such tactic is for brand companies to place restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers, or specialty pharmacies that limit their ability to sell samples to generic drug developers.

In other cases, brand companies may be preventing generic drug developers from accessing samples due to limited distribution programs required by a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU).

“But I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available,” Dr Gottlieb said. “Even in the case of limited distribution programs, such as those required by certain REMS, there should be a path forward for generic drug development.”

With this in mind, the FDA has released a list of brand companies that may have prevented generic drug developers from accessing samples. The list contains 52 brand-name drugs, including Pomalyst, Promacta, Revlimid, Tasigna, and Thalidomid.

Generic drug developers have reported trouble obtaining samples of these drugs and asked the FDA for assistance.

When the FDA receives such a request, the agency first determines whether the product in question has a REMS program with ETASU that may impact distribution.

If the FDA confirms the existence of such a program, the generic company can submit its bioequivalence testing protocol to the FDA. The agency then evaluates this protocol to ensure the plan for testing the product contains safety protections comparable to the brand product’s REMS program.

If a generic developer’s plans include appropriate protections, the developer can request that the FDA send a Safety Determination Letter to the brand company. This letter notes that the REMS program doesn’t prevent the brand company from selling its product to generic drug developers.

The FDA has issued 21 Safety Determination Letters to date, according to Dr Gottlieb.

If a generic drug developer has trouble obtaining samples of a drug for which there is no REMS program with ETASU, the FDA informs the developer that there are no FDA-required restrictions that would prevent it from obtaining samples.

The FDA also notifies the Federal Trade Commission (FTC) of requests from generic drug developers seeking assistance in obtaining samples from brand companies. And the FDA encourages generic drug developers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place.

Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.

Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.

“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.

The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.

Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.

The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.

Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.

Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.

In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.

The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”

The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.

By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.

Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.

“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.

The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.

SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.

Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.

Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.

“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.

The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.

Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.

The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.

Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.

Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.

In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.

The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”

The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.

By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.

Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.

“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.

The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.

SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.

Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.

Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.

“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.

The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.

Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.

The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.

Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.

Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.

In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.

The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”

The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.

By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.

Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.

“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.

The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.

SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.

Rajiv Datta, MD, FACS, FRCS, chief of surgery, South Nassau Communities Hospital, Oceanside, NY, recently received South Nassau’s 2017 Mary Pearson Award. The award is presented annually to an individual for extraordinary effort and individual contributions that advance the hospital’s mission to provide compassionate care and standard-setting health care services.

Dr. Datta, also medical director, Gertrude & Louis Feil Cancer Center, Valley Stream, NY, and director, division of surgical oncology and head and neck surgery, joined South Nassau in 2001 and has since gained an international reputation for leadership and surgical innovation. His leadership allowed Gertrude & Louis Feil Cancer Center to be equipped with cutting-edge cancer treatment technology, and colleagues and patients recognize Dr. Datta for his surgical skill and compassionate demeanor.

The SESC noted that Dr. Greene earned the organization’s Distinguished Service Award for his contributions to the field of surgery, which significantly added to the SESC’s mission of supporting professional development and educational opportunities.

Rajiv Datta, MD, FACS, FRCS, chief of surgery, South Nassau Communities Hospital, Oceanside, NY, recently received South Nassau’s 2017 Mary Pearson Award. The award is presented annually to an individual for extraordinary effort and individual contributions that advance the hospital’s mission to provide compassionate care and standard-setting health care services.

Dr. Datta, also medical director, Gertrude & Louis Feil Cancer Center, Valley Stream, NY, and director, division of surgical oncology and head and neck surgery, joined South Nassau in 2001 and has since gained an international reputation for leadership and surgical innovation. His leadership allowed Gertrude & Louis Feil Cancer Center to be equipped with cutting-edge cancer treatment technology, and colleagues and patients recognize Dr. Datta for his surgical skill and compassionate demeanor.

The SESC noted that Dr. Greene earned the organization’s Distinguished Service Award for his contributions to the field of surgery, which significantly added to the SESC’s mission of supporting professional development and educational opportunities.

Rajiv Datta, MD, FACS, FRCS, chief of surgery, South Nassau Communities Hospital, Oceanside, NY, recently received South Nassau’s 2017 Mary Pearson Award. The award is presented annually to an individual for extraordinary effort and individual contributions that advance the hospital’s mission to provide compassionate care and standard-setting health care services.

Dr. Datta, also medical director, Gertrude & Louis Feil Cancer Center, Valley Stream, NY, and director, division of surgical oncology and head and neck surgery, joined South Nassau in 2001 and has since gained an international reputation for leadership and surgical innovation. His leadership allowed Gertrude & Louis Feil Cancer Center to be equipped with cutting-edge cancer treatment technology, and colleagues and patients recognize Dr. Datta for his surgical skill and compassionate demeanor.

The SESC noted that Dr. Greene earned the organization’s Distinguished Service Award for his contributions to the field of surgery, which significantly added to the SESC’s mission of supporting professional development and educational opportunities.

The American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) seeks feedback from Fellows about existing Medicare documentation requirements that are unnecessary, difficult to understand, complicate the submission of claims, and delay patient care. The DAHP will use surgeon input to establish policy recommendations for regulatory relief under the Centers for Medicare & Medicaid Services (CMS) Documentation Requirements Simplification (DRS) Initiative. The key objectives of the DRS Initiative are to eliminate documentation requirements that are no longer needed and to simplify the remaining documentation requirements to reduce improper payments and appeals. To share your story about Medicare documentation burdens, contact Lauren Foe, ACS Regulatory Associate, at [email protected].

The American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) seeks feedback from Fellows about existing Medicare documentation requirements that are unnecessary, difficult to understand, complicate the submission of claims, and delay patient care. The DAHP will use surgeon input to establish policy recommendations for regulatory relief under the Centers for Medicare & Medicaid Services (CMS) Documentation Requirements Simplification (DRS) Initiative. The key objectives of the DRS Initiative are to eliminate documentation requirements that are no longer needed and to simplify the remaining documentation requirements to reduce improper payments and appeals. To share your story about Medicare documentation burdens, contact Lauren Foe, ACS Regulatory Associate, at [email protected].

The American College of Surgeons (ACS) Division of Advocacy and Health Policy (DAHP) seeks feedback from Fellows about existing Medicare documentation requirements that are unnecessary, difficult to understand, complicate the submission of claims, and delay patient care. The DAHP will use surgeon input to establish policy recommendations for regulatory relief under the Centers for Medicare & Medicaid Services (CMS) Documentation Requirements Simplification (DRS) Initiative. The key objectives of the DRS Initiative are to eliminate documentation requirements that are no longer needed and to simplify the remaining documentation requirements to reduce improper payments and appeals. To share your story about Medicare documentation burdens, contact Lauren Foe, ACS Regulatory Associate, at [email protected].

An estimated 886 bleeding control courses were offered in the days leading up to March 31, the official day of observance, and on the day of the event itself. These courses were led by approximately 3,460 instructors who are now filing reports with the American College of Surgeons (ACS) Stop the Bleed^® office on the number of attendees who completed the training.

Media coverage of the event was significant, with hundreds of local media reports released about the Stop the Bleed Day in their hometown newspapers, television stations, online blogs, and other media outlets across the nation. To date, Stop the Bleed Day has captured 798 media mentions and more than 736 million media impressions.

The ACS Bleedingcontrol.org website was a major source of information about the day. In fact, during the month of March the website experienced a high volume of traffic (174,253 page views). The ACS National Stop the Bleed Day web page (www.bleedingcontrol.org/march31) captured 5,487 page views, and an informational video (goo.gl/QLRnwC) explaining what the event was about captured more than 1,200 views on YouTube. Stop the Bleed training can now be found in all 50 states and in 65 countries.
 

An estimated 886 bleeding control courses were offered in the days leading up to March 31, the official day of observance, and on the day of the event itself. These courses were led by approximately 3,460 instructors who are now filing reports with the American College of Surgeons (ACS) Stop the Bleed^® office on the number of attendees who completed the training.

Media coverage of the event was significant, with hundreds of local media reports released about the Stop the Bleed Day in their hometown newspapers, television stations, online blogs, and other media outlets across the nation. To date, Stop the Bleed Day has captured 798 media mentions and more than 736 million media impressions.

The ACS Bleedingcontrol.org website was a major source of information about the day. In fact, during the month of March the website experienced a high volume of traffic (174,253 page views). The ACS National Stop the Bleed Day web page (www.bleedingcontrol.org/march31) captured 5,487 page views, and an informational video (goo.gl/QLRnwC) explaining what the event was about captured more than 1,200 views on YouTube. Stop the Bleed training can now be found in all 50 states and in 65 countries.
 

An estimated 886 bleeding control courses were offered in the days leading up to March 31, the official day of observance, and on the day of the event itself. These courses were led by approximately 3,460 instructors who are now filing reports with the American College of Surgeons (ACS) Stop the Bleed^® office on the number of attendees who completed the training.

Media coverage of the event was significant, with hundreds of local media reports released about the Stop the Bleed Day in their hometown newspapers, television stations, online blogs, and other media outlets across the nation. To date, Stop the Bleed Day has captured 798 media mentions and more than 736 million media impressions.

The ACS Bleedingcontrol.org website was a major source of information about the day. In fact, during the month of March the website experienced a high volume of traffic (174,253 page views). The ACS National Stop the Bleed Day web page (www.bleedingcontrol.org/march31) captured 5,487 page views, and an informational video (goo.gl/QLRnwC) explaining what the event was about captured more than 1,200 views on YouTube. Stop the Bleed training can now be found in all 50 states and in 65 countries.
 

The American College of Surgeons (ACS) has posted the results of the 2017 Member Survey conducted last summer, to which more than 4,400 ACS Fellows and Associate Fellows responded. An infographic (available at www.facs.org/member-services/2017-survey provides an overview of member response rates, along with information on member work settings, overall satisfaction, the value of membership, the likelihood of recommending membership to others, top member benefits by importance and satisfaction, and member experiences with ACS Chapters. The ACS also has posted more detailed survey findings, available at www.facs.org/member-services/2017-survey/findings along with descriptions of the actions being taken in response to the results.

The survey results were presented to the Board of Regents at its October 2017 meeting. In addition, the results were discussed with the ACS Executive Leadership Team and have been used to develop the 2018 ACS strategic plan.

We value your membership and appreciate you providing this useful feedback. Questions or comments should be directed to the Division of Member Services at [email protected].

The American College of Surgeons (ACS) has posted the results of the 2017 Member Survey conducted last summer, to which more than 4,400 ACS Fellows and Associate Fellows responded. An infographic (available at www.facs.org/member-services/2017-survey provides an overview of member response rates, along with information on member work settings, overall satisfaction, the value of membership, the likelihood of recommending membership to others, top member benefits by importance and satisfaction, and member experiences with ACS Chapters. The ACS also has posted more detailed survey findings, available at www.facs.org/member-services/2017-survey/findings along with descriptions of the actions being taken in response to the results.

The survey results were presented to the Board of Regents at its October 2017 meeting. In addition, the results were discussed with the ACS Executive Leadership Team and have been used to develop the 2018 ACS strategic plan.

We value your membership and appreciate you providing this useful feedback. Questions or comments should be directed to the Division of Member Services at [email protected].

The American College of Surgeons (ACS) has posted the results of the 2017 Member Survey conducted last summer, to which more than 4,400 ACS Fellows and Associate Fellows responded. An infographic (available at www.facs.org/member-services/2017-survey provides an overview of member response rates, along with information on member work settings, overall satisfaction, the value of membership, the likelihood of recommending membership to others, top member benefits by importance and satisfaction, and member experiences with ACS Chapters. The ACS also has posted more detailed survey findings, available at www.facs.org/member-services/2017-survey/findings along with descriptions of the actions being taken in response to the results.

The survey results were presented to the Board of Regents at its October 2017 meeting. In addition, the results were discussed with the ACS Executive Leadership Team and have been used to develop the 2018 ACS strategic plan.

We value your membership and appreciate you providing this useful feedback. Questions or comments should be directed to the Division of Member Services at [email protected].

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award through May 31. The award will be presented at Clinical Congress 2018 in Boston, MA, in recognition of an individual’s significant contributions to the advancement of women in the field of surgery.

The award is named in honor of Mary Edwards Walker, MD, for her role as the first woman surgeon employed by the U.S. Army and the only woman to receive the Congressional Medal of Honor, the highest U.S. Armed Forces decoration for bravery. Dr. Walker’s example paved the way for women surgeons of today.

Nominees must have demonstrated a commitment to the advancement and inspiration of women in surgery and be members of the ACS, either in active practice or retired. WiSC members are ineligible for this award. The awardee is expected to attend Clinical Congress 2018 to accept the honor in person.

All nominations must be accompanied by the following documents:

• A letter of nomination outlining how the nominee has contributed to the advancement of women in the field of surgery

• An up-to-date curriculum vitae (CV) of the nominee

• Self-nominations are acceptable and should include a letter of reference

The letter of nomination and CV should be sent to Connie Bura at [email protected].

Read more about Dr. Walker, complete award eligibility requirements, and the selection process on the ACS website at www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/edwards-walker. Questions can be submitted to [email protected].

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award through May 31. The award will be presented at Clinical Congress 2018 in Boston, MA, in recognition of an individual’s significant contributions to the advancement of women in the field of surgery.

The award is named in honor of Mary Edwards Walker, MD, for her role as the first woman surgeon employed by the U.S. Army and the only woman to receive the Congressional Medal of Honor, the highest U.S. Armed Forces decoration for bravery. Dr. Walker’s example paved the way for women surgeons of today.

Nominees must have demonstrated a commitment to the advancement and inspiration of women in surgery and be members of the ACS, either in active practice or retired. WiSC members are ineligible for this award. The awardee is expected to attend Clinical Congress 2018 to accept the honor in person.

All nominations must be accompanied by the following documents:

• A letter of nomination outlining how the nominee has contributed to the advancement of women in the field of surgery

• An up-to-date curriculum vitae (CV) of the nominee

• Self-nominations are acceptable and should include a letter of reference

The letter of nomination and CV should be sent to Connie Bura at [email protected].

Read more about Dr. Walker, complete award eligibility requirements, and the selection process on the ACS website at www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/edwards-walker. Questions can be submitted to [email protected].

The American College of Surgeons (ACS) Women in Surgery Committee (WiSC) is accepting nominations for the annual Dr. Mary Edwards Walker Inspiring Women in Surgery Award through May 31. The award will be presented at Clinical Congress 2018 in Boston, MA, in recognition of an individual’s significant contributions to the advancement of women in the field of surgery.

The award is named in honor of Mary Edwards Walker, MD, for her role as the first woman surgeon employed by the U.S. Army and the only woman to receive the Congressional Medal of Honor, the highest U.S. Armed Forces decoration for bravery. Dr. Walker’s example paved the way for women surgeons of today.

Nominees must have demonstrated a commitment to the advancement and inspiration of women in surgery and be members of the ACS, either in active practice or retired. WiSC members are ineligible for this award. The awardee is expected to attend Clinical Congress 2018 to accept the honor in person.

All nominations must be accompanied by the following documents:

• A letter of nomination outlining how the nominee has contributed to the advancement of women in the field of surgery

• An up-to-date curriculum vitae (CV) of the nominee

• Self-nominations are acceptable and should include a letter of reference

The letter of nomination and CV should be sent to Connie Bura at [email protected].

Read more about Dr. Walker, complete award eligibility requirements, and the selection process on the ACS website at www.facs.org/about-acs/governance/acs-committees/women-in-surgery-committee/edwards-walker. Questions can be submitted to [email protected].

The family and friends of the late Claude H. Organ, Jr., MD, FACS, Past-President of the American College of Surgeons (ACS), have established an endowment through the ACS Foundation to provide funding for an annual fellowship to be awarded to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The ACS is accepting applications for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship through June 1.

The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than 45 years old who is a member of one of the previously mentioned societies to attend an educational meeting or make an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The 2017 fellow, Kakra Hughes, MD, FACS, visited locations in Ethiopia and Ghana to begin to develop partnerships and a program for resident training in vascular surgery.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted on the ACS website at www.facs.org/member-services/scholarships/special/organ. A decision regarding this year’s awardee is scheduled to be announced in August 2018. Questions and application materials should be submitted to the attention of the ACS Scholarships Administrator at [email protected].

The family and friends of the late Claude H. Organ, Jr., MD, FACS, Past-President of the American College of Surgeons (ACS), have established an endowment through the ACS Foundation to provide funding for an annual fellowship to be awarded to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The ACS is accepting applications for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship through June 1.

The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than 45 years old who is a member of one of the previously mentioned societies to attend an educational meeting or make an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The 2017 fellow, Kakra Hughes, MD, FACS, visited locations in Ethiopia and Ghana to begin to develop partnerships and a program for resident training in vascular surgery.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted on the ACS website at www.facs.org/member-services/scholarships/special/organ. A decision regarding this year’s awardee is scheduled to be announced in August 2018. Questions and application materials should be submitted to the attention of the ACS Scholarships Administrator at [email protected].

The family and friends of the late Claude H. Organ, Jr., MD, FACS, Past-President of the American College of Surgeons (ACS), have established an endowment through the ACS Foundation to provide funding for an annual fellowship to be awarded to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The ACS is accepting applications for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship through June 1.

The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than 45 years old who is a member of one of the previously mentioned societies to attend an educational meeting or make an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The 2017 fellow, Kakra Hughes, MD, FACS, visited locations in Ethiopia and Ghana to begin to develop partnerships and a program for resident training in vascular surgery.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted on the ACS website at www.facs.org/member-services/scholarships/special/organ. A decision regarding this year’s awardee is scheduled to be announced in August 2018. Questions and application materials should be submitted to the attention of the ACS Scholarships Administrator at [email protected].

AUSTIN, TEX. – Canagliflozin can improve renal outcomes in patients with type 2 diabetes, even when they have mild or moderate kidney disease, new data from the CANVAS program suggested.

“The effect of canagliflozin on composite renal outcomes was large, particularly in people with preserved kidney function,” Brendon L. Neuen, MBBS, of University of New South Wales, Sydney, and his associates wrote in a poster. Baseline renal function also did not appear to affect the safety of canagliflozin, the investigators reported at a meeting sponsored by the National Kidney Foundation.

In patients with diabetes mellitus, increased proximal reabsorption of glucose and sodium decreases the amount of sodium reaching the macula densa in the distal convoluted tubule. This results in reduced use of adenosine triphosphate for sodium reabsorption, which thereby decreases adenosine release and vasoconstriction of afferent arterioles. Left unchecked, this dampening of the tubuloglomerular feedback mechanism increases glomerular filtration and leads to diabetic nephropathy.

Sodium glucose cotransporter 2 (SGLT2) inhibitors such as canagliflozin (Invokana) and empagliflozin (Jardiance) help mitigate this pathology by vasoconstricting afferent arterioles. Previously, in an exploratory analysis of the multicenter, placebo-controlled EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) trial, empagliflozin led to modest but statistically significant long-term reductions in urinary albumin secretion for diabetic patients, regardless of their baseline urinary albumin to creatinine ratio (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). Treatment with empagliflozin also significantly reduced the risk of developing microalbuminuria or macroalbuminuria (P less than .0001).

The multicenter, double-blind, placebo-controlled CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) trials included more than 10,000 adults with type 2 diabetes and high cardiovascular risk. In the primary analysis, canagliflozin significantly reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke compared with placebo (N Engl J Med. 2017 Aug 17;377[7]:644-57).

Dr. Neuen and his associates compared the effects of canagliflozin on renal outcomes and safety among CANVAS patients whose estimated glomerular filtration rate (eGFR) was preserved (greater than 60 mL/min per 1.73 m²) or reduced (less than 60 ml/min per 1.73 m²). Actual mean eGFRs in each of these groups were 83 mL/min per 1.73 m² and 49 mL/min per 1.73 m², respectively. Compared with placebo, canagliflozin acutely reduced eGFR in patients with either preserved (average, –2.2 mL/min per 1.73 m²) or reduced (–2.83 mL/min/1.73 m² ) baseline kidney function (P = 0.21).

SOURCE: Neuen BL et al. SCM 2018.
 

AUSTIN, TEX. – Canagliflozin can improve renal outcomes in patients with type 2 diabetes, even when they have mild or moderate kidney disease, new data from the CANVAS program suggested.

“The effect of canagliflozin on composite renal outcomes was large, particularly in people with preserved kidney function,” Brendon L. Neuen, MBBS, of University of New South Wales, Sydney, and his associates wrote in a poster. Baseline renal function also did not appear to affect the safety of canagliflozin, the investigators reported at a meeting sponsored by the National Kidney Foundation.

In patients with diabetes mellitus, increased proximal reabsorption of glucose and sodium decreases the amount of sodium reaching the macula densa in the distal convoluted tubule. This results in reduced use of adenosine triphosphate for sodium reabsorption, which thereby decreases adenosine release and vasoconstriction of afferent arterioles. Left unchecked, this dampening of the tubuloglomerular feedback mechanism increases glomerular filtration and leads to diabetic nephropathy.

Sodium glucose cotransporter 2 (SGLT2) inhibitors such as canagliflozin (Invokana) and empagliflozin (Jardiance) help mitigate this pathology by vasoconstricting afferent arterioles. Previously, in an exploratory analysis of the multicenter, placebo-controlled EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) trial, empagliflozin led to modest but statistically significant long-term reductions in urinary albumin secretion for diabetic patients, regardless of their baseline urinary albumin to creatinine ratio (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). Treatment with empagliflozin also significantly reduced the risk of developing microalbuminuria or macroalbuminuria (P less than .0001).

The multicenter, double-blind, placebo-controlled CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) trials included more than 10,000 adults with type 2 diabetes and high cardiovascular risk. In the primary analysis, canagliflozin significantly reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke compared with placebo (N Engl J Med. 2017 Aug 17;377[7]:644-57).

Dr. Neuen and his associates compared the effects of canagliflozin on renal outcomes and safety among CANVAS patients whose estimated glomerular filtration rate (eGFR) was preserved (greater than 60 mL/min per 1.73 m²) or reduced (less than 60 ml/min per 1.73 m²). Actual mean eGFRs in each of these groups were 83 mL/min per 1.73 m² and 49 mL/min per 1.73 m², respectively. Compared with placebo, canagliflozin acutely reduced eGFR in patients with either preserved (average, –2.2 mL/min per 1.73 m²) or reduced (–2.83 mL/min/1.73 m² ) baseline kidney function (P = 0.21).

SOURCE: Neuen BL et al. SCM 2018.
 

AUSTIN, TEX. – Canagliflozin can improve renal outcomes in patients with type 2 diabetes, even when they have mild or moderate kidney disease, new data from the CANVAS program suggested.

“The effect of canagliflozin on composite renal outcomes was large, particularly in people with preserved kidney function,” Brendon L. Neuen, MBBS, of University of New South Wales, Sydney, and his associates wrote in a poster. Baseline renal function also did not appear to affect the safety of canagliflozin, the investigators reported at a meeting sponsored by the National Kidney Foundation.

In patients with diabetes mellitus, increased proximal reabsorption of glucose and sodium decreases the amount of sodium reaching the macula densa in the distal convoluted tubule. This results in reduced use of adenosine triphosphate for sodium reabsorption, which thereby decreases adenosine release and vasoconstriction of afferent arterioles. Left unchecked, this dampening of the tubuloglomerular feedback mechanism increases glomerular filtration and leads to diabetic nephropathy.

Sodium glucose cotransporter 2 (SGLT2) inhibitors such as canagliflozin (Invokana) and empagliflozin (Jardiance) help mitigate this pathology by vasoconstricting afferent arterioles. Previously, in an exploratory analysis of the multicenter, placebo-controlled EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) trial, empagliflozin led to modest but statistically significant long-term reductions in urinary albumin secretion for diabetic patients, regardless of their baseline urinary albumin to creatinine ratio (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). Treatment with empagliflozin also significantly reduced the risk of developing microalbuminuria or macroalbuminuria (P less than .0001).

The multicenter, double-blind, placebo-controlled CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) trials included more than 10,000 adults with type 2 diabetes and high cardiovascular risk. In the primary analysis, canagliflozin significantly reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke compared with placebo (N Engl J Med. 2017 Aug 17;377[7]:644-57).

Dr. Neuen and his associates compared the effects of canagliflozin on renal outcomes and safety among CANVAS patients whose estimated glomerular filtration rate (eGFR) was preserved (greater than 60 mL/min per 1.73 m²) or reduced (less than 60 ml/min per 1.73 m²). Actual mean eGFRs in each of these groups were 83 mL/min per 1.73 m² and 49 mL/min per 1.73 m², respectively. Compared with placebo, canagliflozin acutely reduced eGFR in patients with either preserved (average, –2.2 mL/min per 1.73 m²) or reduced (–2.83 mL/min/1.73 m² ) baseline kidney function (P = 0.21).

SOURCE: Neuen BL et al. SCM 2018.
 

BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.

BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.

BOSTON – A company that partners patients and health advisers claims to help patients with type 2 diabetes to manage their symptoms and lower their HbA_1c levels.

The Pack Health program connects each patient with a health adviser, who contacts them five times a week using a mix of phone calls, text messages, and emails. The goals include helping patients to find clinicians in their area, make appointments, and adhere to treatment, Dhiren Patel, PharmD, medical director at Pack Health, said at the annual meeting of the American Association of Clinical Endocrinologists.

In a prospective study of 756 type 2 diabetes patients, traditional modes of communication with a health coach were associated with a 1% decrease in HbA_1c within 3 months and the reduction was maintained at 1 year. Patients lost an average of 5 pounds, and annual eye and foot exams increased by 17% and 19%, respectively.

Similar remote health coach initiatives are being used to help other patients with chronic health conditions as part of the Pack Health services, which Dr. Patel discussed in a video interview.

[email protected]

SOURCE: Patel D et al. AACE 2018. Abstract 1209.