User login
Transgender surgery making inroads
The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.
“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”
As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.
“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”
She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.
“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”
Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”
After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.
Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.
“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”
In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.
“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”
During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”
Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.
According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”
When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”
The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.
Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”
Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.
Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”
In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”
Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.
The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.
“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”
As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.
“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”
She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.
“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”
Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”
After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.
Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.
“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”
In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.
“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”
During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”
Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.
According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”
When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”
The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.
Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”
Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.
Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”
In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”
Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.
The way Dr. Marci L. Bowers sees it, societal acceptance of transgender persons has come a long way, and the future of transgender surgery is bright.
“Who thought that we’d have our decathlon winner Bruce Jenner become Caitlyn?” Dr. Bowers said at the annual scientific meeting of the Society of Gynecologic Surgeons in Indian Wells, Calif. “Who thought that the brothers who created “The Matrix” movies [Larry and Andy Wachowski] would become sisters? All in this past year?”
As the first transgender surgeon to perform transgender surgery in North America, Dr. Bowers knows of what she speaks. In fact, she recently joined the faculty at Mount Sinai Beth Israel Medical Center in New York to help launch what she said will be the first U.S.-based surgical training program for transgender medicine in nearly 40 years.
“An academic institution doing these procedures is really revolutionary,” she said. “I think it’s going to really help how things are taught and described to practitioners.”
She said she also hopes the effort helps stem the “high percentage” of transgender teenagers who attempt or commit suicide. According to 7,261 transgender students in grades 6-12 who responded to the 2009 National School Climate Survey, 61% reported feeling unsafe at school because of their sexual orientation and 40% because of how they expressed their gender; 19% said they have been punched, kicked, or injured with a weapon on at least one occasion within the last year because of their sexual orientation and 13% because of their gender expression; and 53% reported cyberbullying because of their gender identity.
“We need to stop losing these people,” she said. “My kids are now in their early 20s. This generation is asking for honesty in the areas of sexuality and gender identity.”
Dr. Bowers, who graduated from the University of Minnesota Medical School in 1986 and did her ob.gyn. residency at the University of Washington, Seattle, characterized the notion of being “misgendered” as a biologic process. “If you look around nature, there is no single measure anywhere in biology that offers only two choices, besides gender,” said Dr. Bowers, who underwent male to female reassignment surgery at age 39. “So when you think about it, the world is represented by a spectrum; it’s represented by diversity. That’s what transgender is, the inner concept of maleness and femaleness. It can’t be just two choices. This is what’s coming to the surface as this movement takes hold.”
After practicing ob.gyn. in Seattle for 13 years, Dr. Bowers relocated to Trinidad, Colo., where she learned and began to practice transgender surgery under the tutelage of the late Dr. Stanley Biber, who performed more than 4,000 sex reassignment surgeries. After working there for 8 years, Dr. Bowers moved her practice to Burlingame, Calif., where she currently performs about 140 male to female operations each year and has a 3-year waiting list. During each 3-hour operation the testicles are removed, the glans penis becomes the clitoris, the scrotum becomes the labia majora, the urethra becomes the labia minora mucosa, the scrotum/penile skin becomes the vagina, and the Cowper’s glands and prostate are retained. Results are “rather convincing,” she said.
Most patients require a hospital stay of up to 3 days, and the most common complication is wound separation/dehiscence, which occurs in 3%-9% of cases. Out-of-pocket costs average about $25,000 per case, but a growing number of insurers now pay for the procedure.
“A dozen years ago, only one company in the Fortune 500 covered transgender surgery,” she said. “Now in our practice, nearly 90% of insurers do, about 70% of the Fortune 500 companies do, and 12 states mandate coverage for all of their citizens to be covered for transgender surgery. It’s really changed.”
In 2009 the American Medical Association passed a resolution supporting public and private insurance coverage for the treatment of gender identity disorder. According to Dr. Bowers, this came about in part because of a 2009 landmark study conducted by the National Center for Transgender Quality and the Gay and Lesbian Task Force that found that more than half of transgender and gender nonconforming people who were bullied, harassed, or assaulted in school because of their gender identity have attempted suicide. In 2011, ACOG’s Committee on Health Care for Underserved Women published an opinion on health care for transgender individuals. Part of its recommendation was that ob. gyns. “should be prepared to assist or refer transgender individuals for routine treatment and screening as well as hormonal and surgical therapies.” According to guidelines from the World Professional Association for Transgender Health (WPATH), individuals seeking transgender surgery should undergo a psychological evaluation, 1 year of cross-sex hormone therapy, and 1 year of desired gender role, and be at least 18 years of age before undergoing surgery itself.
“Gender identity is established early; this is not something that somebody wakes up with,” said Dr. Bowers, who has appeared on “The Oprah Winfrey Show,” “CBS Sunday Morning,” “Discovery Health,” and CNN, and was named one of Huffington Post’s 50 Transgender Icons. “Yes, they need to have a psychological evaluation. Yes, they need to live in their desired gender role, and yes, they need to be on hormones, but other than that, they rarely regret their decision to move forward medically and surgically. Almost never.”
During a presentation at the annual meeting of the American College of Physicians, Dr. Henry Ng noted that some transgender patients are ambivalent about undergoing gender reassignment surgery. “A lot of them don’t want surgery because it’s not a covered benefit under most health plans, it’s expensive, and it does require a lot of healing time because it’s a very invasive procedure,” said Dr. Ng of the departments of internal medicine and pediatrics at Case Western Reserve University, Cleveland. “Especially for certain procedures like phalloplasty, those procedures have not been developed to a point where we can avoid a lot of complications.”
Dr. Ng, who is also clinical director of the MetroHealth Pride Clinic in Cleveland, noted that general health screening guidelines for transgender patients can be found at www.transhealth.ucsf.edu/protocols. “The good news is that it’s really no different than that versus gender people: cardiovascular health; tobacco use; addressing issues of mood disorders/depression, in part related to the experience of microaggressions and macroaggressions from discrimination, violence, and hate-motivated violence on a day-to-day basis; thyroid disease; respiratory illnesses that may be associated with increased use of tobacco products; sexual health; and vaccinations,” he said. “These are all important to include in a general health screening for transgender people.” A free consultation service known as TransLine offers physicians clinical information about transgender issues and individualized case consultation. For information, visit www.project-health.org/transline.
According to the Human Rights Campaign’s Corporate Quality Index, scores of major employers in the United States, including 3M, Amazon.com, American Express, Boeing, General Motors, Johnson & Johnson, Morgan Stanley, Nike, Procter & Gamble, Starbucks, UnitedHealth Group, Visa, and Xerox, offer at least one transgender-inclusive health care coverage plan. A list of insurers who offer transgender health coverage can be found here. The Human Rights Campaign also notes that seven states that have both bans on insurance exclusions for transgender health care and provide transgender inclusive benefits for state employees: New York, Massachusetts, Connecticut, Rhode Island, California, Oregon, and Washington. The National Center for Transgender Quality notes that since May of 2014, Medicare coverage decisions for transition-related surgeries are “made individually on the basis of medical need and applicable standards of care, similar to other doctor or hospital services under Medicare.”
When a patient realizes that his or her employer has not opted in to cover transgender care as part of its health insurance offerings, “it’s heartbreaking to be the middle man,” Dr. Cecile Unger, a surgeon at the Cleveland Clinic center for female pelvic medicine and reconstructive surgery, said in an interview. “Some patients start calculating how much they need to save weekly or monthly [in order to pay out of pocket]. They figure out where they want to have surgery. We provide them with the exact self-pay numbers. They usually will shop around a bit to see what some of the other providers are offering. Some patients will try to get their names on the books a year-and-a-half or two ahead of time.”
The cost of procedures varies. For example, the price of a vaginoplasty at the Philadelphia Center for Transgender Surgery is $12,600, plus $7,150 in anesthesia, operating room, and hospital stay charges, for a total of $19,750. The center’s cost for female to male surgery at the center are slightly higher. For example, the price of a phalloplasty, scrotoplasty, testicular implants, glansplasty, and transposition of the clitoris is $15,500, plus $5,750 in anesthesia, OR, and hospital charges, for a total of $21,250.
Wound separation and wound-healing problems are the most common complications after gender reassignment surgery, Dr. Unger said, “but within 4-12 weeks usually those issues resolve themselves with a bit of conservative wound care, and don’t require more surgery. Infection is quite rare. Hematoma formation is not common in the first few days after surgery. In female to male procedures, there’s a bit of a risk for stricture of the urethra, which can lead to problems with voiding and fistula formation.”
Discussing realistic expectations with patients preoperatively is key, Dr. Unger said, especially in terms of scarring and cosmesis. “Most of the time you get a great result, but patients should also understand that everybody’s anatomy is different and everybody’s wound healing is different, so [they] have to be flexible and understand that secondary procedures are sometimes necessary to get the perfect outcomes,” she said.
Another procedure Dr. Bowers provides in her practice is functional clitoroplasty for females who have undergone genital mutation, a procedure that has impacted an estimated 140 million women worldwide, especially those in Indonesia. “These women often have never had orgasm in their life because all or part of the clitoris and the labia have been excised,” Dr. Bowers said. “It’s one of the great human tragedies.”
In a procedure that takes about an hour, Dr. Bowers restores refibulation and sensation for women who have been genitally mutilated – at no charge to them. “We 100% of the time find the clitoris when we do these operations,” she said. “We refibulate, we release the suspensory ligament, we anchor the clitoral body down, and that restores function. From the letters I receive, this is a miracle for these patients, to feel orgasm for the first time in your life. Imagine restoring sight to a blind person. It’s that profound.”
Dr. Bowers disclosed that she is a member of WPATH and that she serves on the board of directors of GLAAD and the Transgender Law Center. The meeting was jointly sponsored by the American College of Surgeons.
VIDEO: Caring for transgender youth will require care across specialties
BALTIMORE – Training in transgender care needs to be amplified across all specialties, including pediatrics, as the number of transgender individuals, both young and old, continues to climb.
“We all have a gender, we all have a gender identity, we all have a way in which we express that to the world around us, and to ignore that part of a human being [and] a patient would be a real detriment [to] our society,” explained Dr. Kristen Eckstrand a resident in the child psychiatry program at the University of Pittsburgh.
In an interview at the annual meeting of the Pediatric Academic Societies, Dr. Eckstrand discussed strategies for talking to transgender patients to provide the best care for them, and the importance of working across professions and specialties when the situation calls for it.
Dr. Eckstrand did not report any relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Go to LGBT Youth Consult on our site for articles on the nature of sexuality and gender identity and how they affect health, advice on how to talk with your patients about these topics, and how to make your office a safe place for LGBT youth.
BALTIMORE – Training in transgender care needs to be amplified across all specialties, including pediatrics, as the number of transgender individuals, both young and old, continues to climb.
“We all have a gender, we all have a gender identity, we all have a way in which we express that to the world around us, and to ignore that part of a human being [and] a patient would be a real detriment [to] our society,” explained Dr. Kristen Eckstrand a resident in the child psychiatry program at the University of Pittsburgh.
In an interview at the annual meeting of the Pediatric Academic Societies, Dr. Eckstrand discussed strategies for talking to transgender patients to provide the best care for them, and the importance of working across professions and specialties when the situation calls for it.
Dr. Eckstrand did not report any relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Go to LGBT Youth Consult on our site for articles on the nature of sexuality and gender identity and how they affect health, advice on how to talk with your patients about these topics, and how to make your office a safe place for LGBT youth.
BALTIMORE – Training in transgender care needs to be amplified across all specialties, including pediatrics, as the number of transgender individuals, both young and old, continues to climb.
“We all have a gender, we all have a gender identity, we all have a way in which we express that to the world around us, and to ignore that part of a human being [and] a patient would be a real detriment [to] our society,” explained Dr. Kristen Eckstrand a resident in the child psychiatry program at the University of Pittsburgh.
In an interview at the annual meeting of the Pediatric Academic Societies, Dr. Eckstrand discussed strategies for talking to transgender patients to provide the best care for them, and the importance of working across professions and specialties when the situation calls for it.
Dr. Eckstrand did not report any relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Go to LGBT Youth Consult on our site for articles on the nature of sexuality and gender identity and how they affect health, advice on how to talk with your patients about these topics, and how to make your office a safe place for LGBT youth.
AT THE PAS ANNUAL MEETING
VIDEO: Is hysterectomy still best for complex atypical hyperplasia?
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
EXPERT ANALYSIS FROM ACOG 2016
Dealing with compassion fatigue
It was close to 2 decades ago, but it is still as clear as if it had been yesterday. I sat in the intensive care unit, fresh from my residency, tears streaming down my face, which was firmly nestled between my hands as I tried to hide my pain from every soul around me – doctors, nurses, patients’ family members – anyone and everyone.
I had just lost a very dear patient and emotions were running high. I only hoped no one at the nurses’ station would notice me, at least until I had a chance to regain my composure. After all, who would expect to see, or even respect, a doctor found sobbing like a child over a patient who died? Isn’t that all part of the job? Don’t we anticipate the death of some of our most critically ill patients?
Almost paralyzed with grief, I had a hard decision to make.
Option one: I could sit firmly planted in my seat and deal with my personal loss, the loss of my patient with chart number 0001 – yes, my very first patient in private practice. Over time, she and I had developed a very warm, loving relationship, almost like that of a mother and daughter as she was several decades my elder. I had a right to grieve my loss just as anyone else would grieve after losing someone they cared for, didn’t I?
Option two: I could bury my personal feelings and deal with them later in the comfort of my home, safe from the incessant pages from nurses calling about other patients’ urgent needs, hidden from accusing, sometimes condescending glances from other medical professionals who could never understand why I would react so strongly to the death of a patient – especially in a place surrounded by the watchful eyes of others who hold physicians to such a high standard.
Not so much to save face, but for the sake of other critically ill patients who needed a calm, clear-thinking physician to make prudent decisions regarding their care, I chose option two.
As hospitalists, our work is exciting and extremely rewarding, yet with all the suffering and death we see, we must be very careful to guard our hearts and minds, lest we fall into a state of perpetual inner turmoil and stress, and find ourselves seeking counseling or even prescription medication to cope. Compassion satisfaction and compassion fatigue are two ends of a spectrum that caregivers, including medical professionals, often experience. As the names suggest, the former refers to the positive feelings of helping others in need, while the latter refers to a potentially pathologic psychological adaptation to the suffering we experience.
Dr. Charles Figley, director of the Tulane Traumatology Institute in New Orleans, describes compassion fatigue as “a state experienced by those helping people or animals in distress; it is an extreme state of tension and preoccupation with the suffering of those being helped to the degree that it can create a secondary traumatic stress for the helper.”
We all have different coping mechanisms. Some hospitalists are so focused on the art of healing the sick that they have learned to dissociate themselves from the suffering of the individuals they serve, while still delivering excellent care to each and every patient. Not everyone has reached that level.
“Striking the right work-life balance helps me,” said Dr. Marianne Cunanan-Bush, medical director of the inpatient team at Baltimore Washington Medical Center in Glen Burnie, Md. “The first part of my day is spent in personal quiet time, [so] I can just relax and let my mind go free. And my family life is vital. My husband and I play tennis with our children and do other fun things as a family and that helps keep me grounded.”
Dr. Jiayan Chen, a hospitalist at Baltimore Washington Medical Center, finds it almost impossible to completely avoid compassion fatigue. “As hospitalists, I think we can only try to minimize it,” she said. “Try to be sympathetic to patient and family but remain neutral to avoid too high compassion fatigue. Talk to colleagues a couple of times a day, give yourself a few small breaks, including lunch time, drink a cup of water, anything to help break the tension of care during the day.”
Whatever your personal style or inner make-up, be true to yourself. It’s okay to be stoic and to cry sometimes, but if you need help dealing with the trauma and stress this profession sometimes brings, don’t be ashamed to seek the counsel of friends, family members, or even professionals. Two useful resources for help in dealing with, and preventing, compassion fatigue are the Compassion Fatigue Awareness Project and ProQOL.org.
Those of you with small children will appreciate this more than others: As the words of a popular song sung by little girls from coast to coast say, “Let it go, let it go. Don’t hold it back anymore!”
Dr. Hester is a hospitalist at Baltimore Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
It was close to 2 decades ago, but it is still as clear as if it had been yesterday. I sat in the intensive care unit, fresh from my residency, tears streaming down my face, which was firmly nestled between my hands as I tried to hide my pain from every soul around me – doctors, nurses, patients’ family members – anyone and everyone.
I had just lost a very dear patient and emotions were running high. I only hoped no one at the nurses’ station would notice me, at least until I had a chance to regain my composure. After all, who would expect to see, or even respect, a doctor found sobbing like a child over a patient who died? Isn’t that all part of the job? Don’t we anticipate the death of some of our most critically ill patients?
Almost paralyzed with grief, I had a hard decision to make.
Option one: I could sit firmly planted in my seat and deal with my personal loss, the loss of my patient with chart number 0001 – yes, my very first patient in private practice. Over time, she and I had developed a very warm, loving relationship, almost like that of a mother and daughter as she was several decades my elder. I had a right to grieve my loss just as anyone else would grieve after losing someone they cared for, didn’t I?
Option two: I could bury my personal feelings and deal with them later in the comfort of my home, safe from the incessant pages from nurses calling about other patients’ urgent needs, hidden from accusing, sometimes condescending glances from other medical professionals who could never understand why I would react so strongly to the death of a patient – especially in a place surrounded by the watchful eyes of others who hold physicians to such a high standard.
Not so much to save face, but for the sake of other critically ill patients who needed a calm, clear-thinking physician to make prudent decisions regarding their care, I chose option two.
As hospitalists, our work is exciting and extremely rewarding, yet with all the suffering and death we see, we must be very careful to guard our hearts and minds, lest we fall into a state of perpetual inner turmoil and stress, and find ourselves seeking counseling or even prescription medication to cope. Compassion satisfaction and compassion fatigue are two ends of a spectrum that caregivers, including medical professionals, often experience. As the names suggest, the former refers to the positive feelings of helping others in need, while the latter refers to a potentially pathologic psychological adaptation to the suffering we experience.
Dr. Charles Figley, director of the Tulane Traumatology Institute in New Orleans, describes compassion fatigue as “a state experienced by those helping people or animals in distress; it is an extreme state of tension and preoccupation with the suffering of those being helped to the degree that it can create a secondary traumatic stress for the helper.”
We all have different coping mechanisms. Some hospitalists are so focused on the art of healing the sick that they have learned to dissociate themselves from the suffering of the individuals they serve, while still delivering excellent care to each and every patient. Not everyone has reached that level.
“Striking the right work-life balance helps me,” said Dr. Marianne Cunanan-Bush, medical director of the inpatient team at Baltimore Washington Medical Center in Glen Burnie, Md. “The first part of my day is spent in personal quiet time, [so] I can just relax and let my mind go free. And my family life is vital. My husband and I play tennis with our children and do other fun things as a family and that helps keep me grounded.”
Dr. Jiayan Chen, a hospitalist at Baltimore Washington Medical Center, finds it almost impossible to completely avoid compassion fatigue. “As hospitalists, I think we can only try to minimize it,” she said. “Try to be sympathetic to patient and family but remain neutral to avoid too high compassion fatigue. Talk to colleagues a couple of times a day, give yourself a few small breaks, including lunch time, drink a cup of water, anything to help break the tension of care during the day.”
Whatever your personal style or inner make-up, be true to yourself. It’s okay to be stoic and to cry sometimes, but if you need help dealing with the trauma and stress this profession sometimes brings, don’t be ashamed to seek the counsel of friends, family members, or even professionals. Two useful resources for help in dealing with, and preventing, compassion fatigue are the Compassion Fatigue Awareness Project and ProQOL.org.
Those of you with small children will appreciate this more than others: As the words of a popular song sung by little girls from coast to coast say, “Let it go, let it go. Don’t hold it back anymore!”
Dr. Hester is a hospitalist at Baltimore Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
It was close to 2 decades ago, but it is still as clear as if it had been yesterday. I sat in the intensive care unit, fresh from my residency, tears streaming down my face, which was firmly nestled between my hands as I tried to hide my pain from every soul around me – doctors, nurses, patients’ family members – anyone and everyone.
I had just lost a very dear patient and emotions were running high. I only hoped no one at the nurses’ station would notice me, at least until I had a chance to regain my composure. After all, who would expect to see, or even respect, a doctor found sobbing like a child over a patient who died? Isn’t that all part of the job? Don’t we anticipate the death of some of our most critically ill patients?
Almost paralyzed with grief, I had a hard decision to make.
Option one: I could sit firmly planted in my seat and deal with my personal loss, the loss of my patient with chart number 0001 – yes, my very first patient in private practice. Over time, she and I had developed a very warm, loving relationship, almost like that of a mother and daughter as she was several decades my elder. I had a right to grieve my loss just as anyone else would grieve after losing someone they cared for, didn’t I?
Option two: I could bury my personal feelings and deal with them later in the comfort of my home, safe from the incessant pages from nurses calling about other patients’ urgent needs, hidden from accusing, sometimes condescending glances from other medical professionals who could never understand why I would react so strongly to the death of a patient – especially in a place surrounded by the watchful eyes of others who hold physicians to such a high standard.
Not so much to save face, but for the sake of other critically ill patients who needed a calm, clear-thinking physician to make prudent decisions regarding their care, I chose option two.
As hospitalists, our work is exciting and extremely rewarding, yet with all the suffering and death we see, we must be very careful to guard our hearts and minds, lest we fall into a state of perpetual inner turmoil and stress, and find ourselves seeking counseling or even prescription medication to cope. Compassion satisfaction and compassion fatigue are two ends of a spectrum that caregivers, including medical professionals, often experience. As the names suggest, the former refers to the positive feelings of helping others in need, while the latter refers to a potentially pathologic psychological adaptation to the suffering we experience.
Dr. Charles Figley, director of the Tulane Traumatology Institute in New Orleans, describes compassion fatigue as “a state experienced by those helping people or animals in distress; it is an extreme state of tension and preoccupation with the suffering of those being helped to the degree that it can create a secondary traumatic stress for the helper.”
We all have different coping mechanisms. Some hospitalists are so focused on the art of healing the sick that they have learned to dissociate themselves from the suffering of the individuals they serve, while still delivering excellent care to each and every patient. Not everyone has reached that level.
“Striking the right work-life balance helps me,” said Dr. Marianne Cunanan-Bush, medical director of the inpatient team at Baltimore Washington Medical Center in Glen Burnie, Md. “The first part of my day is spent in personal quiet time, [so] I can just relax and let my mind go free. And my family life is vital. My husband and I play tennis with our children and do other fun things as a family and that helps keep me grounded.”
Dr. Jiayan Chen, a hospitalist at Baltimore Washington Medical Center, finds it almost impossible to completely avoid compassion fatigue. “As hospitalists, I think we can only try to minimize it,” she said. “Try to be sympathetic to patient and family but remain neutral to avoid too high compassion fatigue. Talk to colleagues a couple of times a day, give yourself a few small breaks, including lunch time, drink a cup of water, anything to help break the tension of care during the day.”
Whatever your personal style or inner make-up, be true to yourself. It’s okay to be stoic and to cry sometimes, but if you need help dealing with the trauma and stress this profession sometimes brings, don’t be ashamed to seek the counsel of friends, family members, or even professionals. Two useful resources for help in dealing with, and preventing, compassion fatigue are the Compassion Fatigue Awareness Project and ProQOL.org.
Those of you with small children will appreciate this more than others: As the words of a popular song sung by little girls from coast to coast say, “Let it go, let it go. Don’t hold it back anymore!”
Dr. Hester is a hospitalist at Baltimore Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].
Management of Vitiligo Patients With Surgical Interventions
Vitiligo is a common, asymptomatic, acquired depigmentation disorder that is caused by an unknown etiology. Lesions appear as sharply demarcated, depigmented macules and patches that are scattered symmetrically or unsymmetrically over the body. The presentation can be delineated based on the segmental or nonsegmental nature of the disease. According to the revised classification/nomenclature of vitiligo,1 the disorder can be classified as nonsegmental, segmental, mixed, or unclassified. The pathogenesis of the vitiligo disease process is due to multiple modalities that contribute to melanocyte loss. Theories for melanocyte destruction include but are not limited to autoimmunity, biochemicals, epidermal cytokines, increased hydrogen peroxide and free radicals, and humoral and cellular immune alteration.2,3
Despite its long history, the most frustrating aspect of the vitiligo disease process remains its treatment due to limited efficacy, frequent application of topicals, and the need for high-potency steroids. Medical therapies usually are the first line of treatment and are most effective with few side effects for bilateral nonsegmental or evolving vitiligo.2 Some of the primary therapies with the highest efficacies appear to be calcipotriene and psoralen plus UVA, psoralen plus UVA as monotherapy, excimer laser, narrowband UVB, oral steroids, 8-methoxypsoralen, tacrolimus, and topical steroids.4 The theory is that these treatments would be successful if the patient had active melanocytes in the external root sheath that would be able to repigment a patch of vitiligo.5 Hence, it would be more difficult to treat areas such as the dorsal aspect of the fingers and toes because they lack hair-bearing areas with melanocytes.6 The alternative approach to treating vitiligo patches would be surgical intervention techniques, as they provide melanocytic cells to a previously depigmented area.3,5 The focus of this article is to evaluate the efficacy and appropriate use of some of the surgical procedures that can be used in the treatment of vitiligo patients.
Candidate Selection
First, vitiligo patients for whom first-line treatment with medical therapies has failed are candidates for surgical techniques. The second vital component is to clinically confirm the diagnosis of vitiligo as opposed to other genetic, infectious, or autoimmune causes of pigment loss. Lastly, the vitiligo patch should be stable. A stable vitiligo patch does not continue to progress and is no longer responsive to topical medications that are meant to repigment for a discernible period of time.7
Classification of Disease Stage
To classify the stage of vitiligo prior to surgical intervention, Gauthier8 created a basic grading system: grade I, with partial depletion of epidermal melanocytes in a vitiligo patch that responds to repigmentation in a follicular pattern evenly such as on the face and neck; grade II, with complete depletion of epidermal melanocytes with a usual follicular pattern of repigmentation; and grade III, indicating complete depletion of follicular melanocytes with no hope of response to medical therapy. According to Rusfianti and Wirohadidjodjo,2 the surgical techniques that have developed over the years for treatment of grade III vitiligo patients include split-thickness skin grafting, suction blister grafting, miniature punch grafting, and cultured melanocyte transplantation.
Surgical Techniques
Split-thickness skin grafting is an older procedure that entails the use of a harvesting graft site with no pigment loss and dermabrasion of the recipient area to allow interaction with the wound bed.9 With proper care and minimal movement or wrinkling of the graft site, patients can have repigmentation without skip areas.
Suction blister grafting is another tried and tested surgical intervention. Hasegawa et al10 conducted a study of 15 patients (13 males, 2 females; age range, 16–38 years) diagnosed with segmental vitiligo who were treated using the suction blister grafting technique with CO2 laser resurfacing. Patients were recruited 1 month prior to initiating therapy and no other treatments were used during the month or in conjunction with the surgical intervention. Suction blisters were harvested from the left thigh and transferred in saline to the recipient site, which was abraded with 1 pass of the short-pulse CO2 laser system. The recipient sites were then closed with 7-0 nylon sutures and covered tightly with tie-over dressings for at least 1 week. Within 6 months of the procedure, a treatment response of 100% was seen in 15 patients, making it an effective method for treatment-resistant vitiligo patients.10
Miniature punch grafting is another possible treatment option for resistant cases of vitiligo. Mapar et al11 conducted a study in 25 patients (21 women, 4 men; age range, 20–47 years) who had been diagnosed with stable vitiligo (ie, no progression in the last 2 years) and were treated with single hair follicle transplant versus miniature punch grafting. The theory behind the study was to use the melanocytic reservoir noted in the normal hair follicle to repigment the vitiligo patch. With follow-up of both methods of treatment, there was no statistical difference in treatment results.11 A similar study was conducted by Malakar and Lahiri12 in patients with lip leukoderma (a variant of vitiligo). One hundred eight patients (41 males, 67 females; age range, 14–62 years) who had been diagnosed with stable lip leukoderma (ie, stable vitiligo for at least 6 months) underwent treatment via autologous miniature punch grafting. Punch biopsies were performed in donor sites of the buttocks and upper thighs with 72% of patients noting complete repigmentation. Complications noted were herpes labialis–induced lip leukoderma, which ultimately led to rejection of the graft site.12 Overall, however, miniature punch grafting is a viable surgical option in stable vitiligo patients.
Cultured melanocyte transplantation, or a noncultured epidermal suspension, was first initiated in 1992.13 Silpa-Archa et al14 conducted an open, split-comparison study of 6 vitiligo patients (5 women, 1 man; age range, 20–65 years) with stable lesions. Fifty percent of patients received autologous pigmented skin cellular suspension, which was applied to vitiligo-affected skin that was treated with a fractionated CO2 laser, and 50% received dermabrasion. Composite dressing was placed overlying the site with dressing removal in 1 week. The degree of repigmentation was based on a modified vitiligo area scoring index scale of poor (0%–25%), fair (26%–50%), good (51%–75%), very good (76%–90%), or excellent (91%–100%). Overall repigmentation was very good to excellent in all 6 patients.14 Potentially, this method can far improve the surgical treatment options for future vitiligo patients.
Final Thoughts
Overall, when evaluating surgical interventions for the treatment of vitiligo, careful consideration of the patient’s disease progression, failed therapies, outcome expectations, and repigmentation is warranted prior to initiating any procedure. For appropriate candidates, a range of surgical methodologies has proven to be effective in treatment of stable vitiligo patients.
- Taïeb A, Picardo M; VETF members. The definition and assessment of vitiligo: a consensus report of the Vitiligo European Task Force. Pigment Cell Res. 2007;20:27-35. Cited by: Ezzedine K, Lim HW, Suzuki T, et al; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25:E1-E13.
- Rusfianti M, Wirohadidjodjo YW. Dermatosurgical techniques for repigmentation of vitiligo. Int J Dermatol. 2006;45:411-417.
- Falabella R. Surgical therapies for vitiligo. Clin Dermatol. 1997;15:927-939.
- Whitton ME, Pinart M, Batchelor J, et al. Interventions for vitiligo. Cochrane Database Syst Rev. 2015;2:CD003263.
- Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013;169(suppl 3):57-66.
- Dutta AK, Mandal SB. A clinical study of 650 vitiligo cases and their classification. Indian J Dermatol. 1969;14:103-111.
- Falabella R, Arrunategui A, Barona MI, et al. The minigrafting test for vitiligo: detection of stable lesions for melanocyte transplantation. J Am Acad Dermatol. 1995;32:228-232.
- Gauthier Y. Le vitiligo. Gaz Med. 1994;101:8-12.
- Malakar S, Malakar RS. Surgical pearl: composite film and graft unit for the recipient area dressing after split-thickness skin grafting in vitiligo. J Am Acad Dermatol. 2001;44:856-858.
- Hasegawa T, Suga Y, Ikejima A, et al. Suction blister grafting with CO2 laser resurfacing of the graft recipient site for vitiligo. J Dermatol. 2007;34:490-492.
- Mapar MA, Safarpour M, Mapar M, et al. A comparative study of the mini-punch grafting and hair follicle transplantation in the treatment of refractory and stable vitiligo. J Am Acad Dermatol. 2014;70:743-747.
- Malakar S, Lahiri K. Punch grafting for lip leukoderma. Dermatology. 2004;208:125-128.
- Gauthier Y, Surleve-Bazeille JE. Autologous grafting with noncultured melanocytes: a simplified method for treatment of depigmented lesions. J Am Acad Dermatol. 1992;26(2, pt 1):191-194.
- Silpa-Archa N, Griffith JL, Williams MS, et al. Prospective comparison of recipient-site preparation with fractional carbon dioxide laser versus dermabrasion and recipient-site dressing composition in melanocyte-keratinocyte transplantation procedure in vitiligo: a preliminary study [published online January 24, 2016]. Br J Dermatol. 2016;174:895-897.
Vitiligo is a common, asymptomatic, acquired depigmentation disorder that is caused by an unknown etiology. Lesions appear as sharply demarcated, depigmented macules and patches that are scattered symmetrically or unsymmetrically over the body. The presentation can be delineated based on the segmental or nonsegmental nature of the disease. According to the revised classification/nomenclature of vitiligo,1 the disorder can be classified as nonsegmental, segmental, mixed, or unclassified. The pathogenesis of the vitiligo disease process is due to multiple modalities that contribute to melanocyte loss. Theories for melanocyte destruction include but are not limited to autoimmunity, biochemicals, epidermal cytokines, increased hydrogen peroxide and free radicals, and humoral and cellular immune alteration.2,3
Despite its long history, the most frustrating aspect of the vitiligo disease process remains its treatment due to limited efficacy, frequent application of topicals, and the need for high-potency steroids. Medical therapies usually are the first line of treatment and are most effective with few side effects for bilateral nonsegmental or evolving vitiligo.2 Some of the primary therapies with the highest efficacies appear to be calcipotriene and psoralen plus UVA, psoralen plus UVA as monotherapy, excimer laser, narrowband UVB, oral steroids, 8-methoxypsoralen, tacrolimus, and topical steroids.4 The theory is that these treatments would be successful if the patient had active melanocytes in the external root sheath that would be able to repigment a patch of vitiligo.5 Hence, it would be more difficult to treat areas such as the dorsal aspect of the fingers and toes because they lack hair-bearing areas with melanocytes.6 The alternative approach to treating vitiligo patches would be surgical intervention techniques, as they provide melanocytic cells to a previously depigmented area.3,5 The focus of this article is to evaluate the efficacy and appropriate use of some of the surgical procedures that can be used in the treatment of vitiligo patients.
Candidate Selection
First, vitiligo patients for whom first-line treatment with medical therapies has failed are candidates for surgical techniques. The second vital component is to clinically confirm the diagnosis of vitiligo as opposed to other genetic, infectious, or autoimmune causes of pigment loss. Lastly, the vitiligo patch should be stable. A stable vitiligo patch does not continue to progress and is no longer responsive to topical medications that are meant to repigment for a discernible period of time.7
Classification of Disease Stage
To classify the stage of vitiligo prior to surgical intervention, Gauthier8 created a basic grading system: grade I, with partial depletion of epidermal melanocytes in a vitiligo patch that responds to repigmentation in a follicular pattern evenly such as on the face and neck; grade II, with complete depletion of epidermal melanocytes with a usual follicular pattern of repigmentation; and grade III, indicating complete depletion of follicular melanocytes with no hope of response to medical therapy. According to Rusfianti and Wirohadidjodjo,2 the surgical techniques that have developed over the years for treatment of grade III vitiligo patients include split-thickness skin grafting, suction blister grafting, miniature punch grafting, and cultured melanocyte transplantation.
Surgical Techniques
Split-thickness skin grafting is an older procedure that entails the use of a harvesting graft site with no pigment loss and dermabrasion of the recipient area to allow interaction with the wound bed.9 With proper care and minimal movement or wrinkling of the graft site, patients can have repigmentation without skip areas.
Suction blister grafting is another tried and tested surgical intervention. Hasegawa et al10 conducted a study of 15 patients (13 males, 2 females; age range, 16–38 years) diagnosed with segmental vitiligo who were treated using the suction blister grafting technique with CO2 laser resurfacing. Patients were recruited 1 month prior to initiating therapy and no other treatments were used during the month or in conjunction with the surgical intervention. Suction blisters were harvested from the left thigh and transferred in saline to the recipient site, which was abraded with 1 pass of the short-pulse CO2 laser system. The recipient sites were then closed with 7-0 nylon sutures and covered tightly with tie-over dressings for at least 1 week. Within 6 months of the procedure, a treatment response of 100% was seen in 15 patients, making it an effective method for treatment-resistant vitiligo patients.10
Miniature punch grafting is another possible treatment option for resistant cases of vitiligo. Mapar et al11 conducted a study in 25 patients (21 women, 4 men; age range, 20–47 years) who had been diagnosed with stable vitiligo (ie, no progression in the last 2 years) and were treated with single hair follicle transplant versus miniature punch grafting. The theory behind the study was to use the melanocytic reservoir noted in the normal hair follicle to repigment the vitiligo patch. With follow-up of both methods of treatment, there was no statistical difference in treatment results.11 A similar study was conducted by Malakar and Lahiri12 in patients with lip leukoderma (a variant of vitiligo). One hundred eight patients (41 males, 67 females; age range, 14–62 years) who had been diagnosed with stable lip leukoderma (ie, stable vitiligo for at least 6 months) underwent treatment via autologous miniature punch grafting. Punch biopsies were performed in donor sites of the buttocks and upper thighs with 72% of patients noting complete repigmentation. Complications noted were herpes labialis–induced lip leukoderma, which ultimately led to rejection of the graft site.12 Overall, however, miniature punch grafting is a viable surgical option in stable vitiligo patients.
Cultured melanocyte transplantation, or a noncultured epidermal suspension, was first initiated in 1992.13 Silpa-Archa et al14 conducted an open, split-comparison study of 6 vitiligo patients (5 women, 1 man; age range, 20–65 years) with stable lesions. Fifty percent of patients received autologous pigmented skin cellular suspension, which was applied to vitiligo-affected skin that was treated with a fractionated CO2 laser, and 50% received dermabrasion. Composite dressing was placed overlying the site with dressing removal in 1 week. The degree of repigmentation was based on a modified vitiligo area scoring index scale of poor (0%–25%), fair (26%–50%), good (51%–75%), very good (76%–90%), or excellent (91%–100%). Overall repigmentation was very good to excellent in all 6 patients.14 Potentially, this method can far improve the surgical treatment options for future vitiligo patients.
Final Thoughts
Overall, when evaluating surgical interventions for the treatment of vitiligo, careful consideration of the patient’s disease progression, failed therapies, outcome expectations, and repigmentation is warranted prior to initiating any procedure. For appropriate candidates, a range of surgical methodologies has proven to be effective in treatment of stable vitiligo patients.
Vitiligo is a common, asymptomatic, acquired depigmentation disorder that is caused by an unknown etiology. Lesions appear as sharply demarcated, depigmented macules and patches that are scattered symmetrically or unsymmetrically over the body. The presentation can be delineated based on the segmental or nonsegmental nature of the disease. According to the revised classification/nomenclature of vitiligo,1 the disorder can be classified as nonsegmental, segmental, mixed, or unclassified. The pathogenesis of the vitiligo disease process is due to multiple modalities that contribute to melanocyte loss. Theories for melanocyte destruction include but are not limited to autoimmunity, biochemicals, epidermal cytokines, increased hydrogen peroxide and free radicals, and humoral and cellular immune alteration.2,3
Despite its long history, the most frustrating aspect of the vitiligo disease process remains its treatment due to limited efficacy, frequent application of topicals, and the need for high-potency steroids. Medical therapies usually are the first line of treatment and are most effective with few side effects for bilateral nonsegmental or evolving vitiligo.2 Some of the primary therapies with the highest efficacies appear to be calcipotriene and psoralen plus UVA, psoralen plus UVA as monotherapy, excimer laser, narrowband UVB, oral steroids, 8-methoxypsoralen, tacrolimus, and topical steroids.4 The theory is that these treatments would be successful if the patient had active melanocytes in the external root sheath that would be able to repigment a patch of vitiligo.5 Hence, it would be more difficult to treat areas such as the dorsal aspect of the fingers and toes because they lack hair-bearing areas with melanocytes.6 The alternative approach to treating vitiligo patches would be surgical intervention techniques, as they provide melanocytic cells to a previously depigmented area.3,5 The focus of this article is to evaluate the efficacy and appropriate use of some of the surgical procedures that can be used in the treatment of vitiligo patients.
Candidate Selection
First, vitiligo patients for whom first-line treatment with medical therapies has failed are candidates for surgical techniques. The second vital component is to clinically confirm the diagnosis of vitiligo as opposed to other genetic, infectious, or autoimmune causes of pigment loss. Lastly, the vitiligo patch should be stable. A stable vitiligo patch does not continue to progress and is no longer responsive to topical medications that are meant to repigment for a discernible period of time.7
Classification of Disease Stage
To classify the stage of vitiligo prior to surgical intervention, Gauthier8 created a basic grading system: grade I, with partial depletion of epidermal melanocytes in a vitiligo patch that responds to repigmentation in a follicular pattern evenly such as on the face and neck; grade II, with complete depletion of epidermal melanocytes with a usual follicular pattern of repigmentation; and grade III, indicating complete depletion of follicular melanocytes with no hope of response to medical therapy. According to Rusfianti and Wirohadidjodjo,2 the surgical techniques that have developed over the years for treatment of grade III vitiligo patients include split-thickness skin grafting, suction blister grafting, miniature punch grafting, and cultured melanocyte transplantation.
Surgical Techniques
Split-thickness skin grafting is an older procedure that entails the use of a harvesting graft site with no pigment loss and dermabrasion of the recipient area to allow interaction with the wound bed.9 With proper care and minimal movement or wrinkling of the graft site, patients can have repigmentation without skip areas.
Suction blister grafting is another tried and tested surgical intervention. Hasegawa et al10 conducted a study of 15 patients (13 males, 2 females; age range, 16–38 years) diagnosed with segmental vitiligo who were treated using the suction blister grafting technique with CO2 laser resurfacing. Patients were recruited 1 month prior to initiating therapy and no other treatments were used during the month or in conjunction with the surgical intervention. Suction blisters were harvested from the left thigh and transferred in saline to the recipient site, which was abraded with 1 pass of the short-pulse CO2 laser system. The recipient sites were then closed with 7-0 nylon sutures and covered tightly with tie-over dressings for at least 1 week. Within 6 months of the procedure, a treatment response of 100% was seen in 15 patients, making it an effective method for treatment-resistant vitiligo patients.10
Miniature punch grafting is another possible treatment option for resistant cases of vitiligo. Mapar et al11 conducted a study in 25 patients (21 women, 4 men; age range, 20–47 years) who had been diagnosed with stable vitiligo (ie, no progression in the last 2 years) and were treated with single hair follicle transplant versus miniature punch grafting. The theory behind the study was to use the melanocytic reservoir noted in the normal hair follicle to repigment the vitiligo patch. With follow-up of both methods of treatment, there was no statistical difference in treatment results.11 A similar study was conducted by Malakar and Lahiri12 in patients with lip leukoderma (a variant of vitiligo). One hundred eight patients (41 males, 67 females; age range, 14–62 years) who had been diagnosed with stable lip leukoderma (ie, stable vitiligo for at least 6 months) underwent treatment via autologous miniature punch grafting. Punch biopsies were performed in donor sites of the buttocks and upper thighs with 72% of patients noting complete repigmentation. Complications noted were herpes labialis–induced lip leukoderma, which ultimately led to rejection of the graft site.12 Overall, however, miniature punch grafting is a viable surgical option in stable vitiligo patients.
Cultured melanocyte transplantation, or a noncultured epidermal suspension, was first initiated in 1992.13 Silpa-Archa et al14 conducted an open, split-comparison study of 6 vitiligo patients (5 women, 1 man; age range, 20–65 years) with stable lesions. Fifty percent of patients received autologous pigmented skin cellular suspension, which was applied to vitiligo-affected skin that was treated with a fractionated CO2 laser, and 50% received dermabrasion. Composite dressing was placed overlying the site with dressing removal in 1 week. The degree of repigmentation was based on a modified vitiligo area scoring index scale of poor (0%–25%), fair (26%–50%), good (51%–75%), very good (76%–90%), or excellent (91%–100%). Overall repigmentation was very good to excellent in all 6 patients.14 Potentially, this method can far improve the surgical treatment options for future vitiligo patients.
Final Thoughts
Overall, when evaluating surgical interventions for the treatment of vitiligo, careful consideration of the patient’s disease progression, failed therapies, outcome expectations, and repigmentation is warranted prior to initiating any procedure. For appropriate candidates, a range of surgical methodologies has proven to be effective in treatment of stable vitiligo patients.
- Taïeb A, Picardo M; VETF members. The definition and assessment of vitiligo: a consensus report of the Vitiligo European Task Force. Pigment Cell Res. 2007;20:27-35. Cited by: Ezzedine K, Lim HW, Suzuki T, et al; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25:E1-E13.
- Rusfianti M, Wirohadidjodjo YW. Dermatosurgical techniques for repigmentation of vitiligo. Int J Dermatol. 2006;45:411-417.
- Falabella R. Surgical therapies for vitiligo. Clin Dermatol. 1997;15:927-939.
- Whitton ME, Pinart M, Batchelor J, et al. Interventions for vitiligo. Cochrane Database Syst Rev. 2015;2:CD003263.
- Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013;169(suppl 3):57-66.
- Dutta AK, Mandal SB. A clinical study of 650 vitiligo cases and their classification. Indian J Dermatol. 1969;14:103-111.
- Falabella R, Arrunategui A, Barona MI, et al. The minigrafting test for vitiligo: detection of stable lesions for melanocyte transplantation. J Am Acad Dermatol. 1995;32:228-232.
- Gauthier Y. Le vitiligo. Gaz Med. 1994;101:8-12.
- Malakar S, Malakar RS. Surgical pearl: composite film and graft unit for the recipient area dressing after split-thickness skin grafting in vitiligo. J Am Acad Dermatol. 2001;44:856-858.
- Hasegawa T, Suga Y, Ikejima A, et al. Suction blister grafting with CO2 laser resurfacing of the graft recipient site for vitiligo. J Dermatol. 2007;34:490-492.
- Mapar MA, Safarpour M, Mapar M, et al. A comparative study of the mini-punch grafting and hair follicle transplantation in the treatment of refractory and stable vitiligo. J Am Acad Dermatol. 2014;70:743-747.
- Malakar S, Lahiri K. Punch grafting for lip leukoderma. Dermatology. 2004;208:125-128.
- Gauthier Y, Surleve-Bazeille JE. Autologous grafting with noncultured melanocytes: a simplified method for treatment of depigmented lesions. J Am Acad Dermatol. 1992;26(2, pt 1):191-194.
- Silpa-Archa N, Griffith JL, Williams MS, et al. Prospective comparison of recipient-site preparation with fractional carbon dioxide laser versus dermabrasion and recipient-site dressing composition in melanocyte-keratinocyte transplantation procedure in vitiligo: a preliminary study [published online January 24, 2016]. Br J Dermatol. 2016;174:895-897.
- Taïeb A, Picardo M; VETF members. The definition and assessment of vitiligo: a consensus report of the Vitiligo European Task Force. Pigment Cell Res. 2007;20:27-35. Cited by: Ezzedine K, Lim HW, Suzuki T, et al; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25:E1-E13.
- Rusfianti M, Wirohadidjodjo YW. Dermatosurgical techniques for repigmentation of vitiligo. Int J Dermatol. 2006;45:411-417.
- Falabella R. Surgical therapies for vitiligo. Clin Dermatol. 1997;15:927-939.
- Whitton ME, Pinart M, Batchelor J, et al. Interventions for vitiligo. Cochrane Database Syst Rev. 2015;2:CD003263.
- Mulekar SV, Isedeh P. Surgical interventions for vitiligo: an evidence-based review. Br J Dermatol. 2013;169(suppl 3):57-66.
- Dutta AK, Mandal SB. A clinical study of 650 vitiligo cases and their classification. Indian J Dermatol. 1969;14:103-111.
- Falabella R, Arrunategui A, Barona MI, et al. The minigrafting test for vitiligo: detection of stable lesions for melanocyte transplantation. J Am Acad Dermatol. 1995;32:228-232.
- Gauthier Y. Le vitiligo. Gaz Med. 1994;101:8-12.
- Malakar S, Malakar RS. Surgical pearl: composite film and graft unit for the recipient area dressing after split-thickness skin grafting in vitiligo. J Am Acad Dermatol. 2001;44:856-858.
- Hasegawa T, Suga Y, Ikejima A, et al. Suction blister grafting with CO2 laser resurfacing of the graft recipient site for vitiligo. J Dermatol. 2007;34:490-492.
- Mapar MA, Safarpour M, Mapar M, et al. A comparative study of the mini-punch grafting and hair follicle transplantation in the treatment of refractory and stable vitiligo. J Am Acad Dermatol. 2014;70:743-747.
- Malakar S, Lahiri K. Punch grafting for lip leukoderma. Dermatology. 2004;208:125-128.
- Gauthier Y, Surleve-Bazeille JE. Autologous grafting with noncultured melanocytes: a simplified method for treatment of depigmented lesions. J Am Acad Dermatol. 1992;26(2, pt 1):191-194.
- Silpa-Archa N, Griffith JL, Williams MS, et al. Prospective comparison of recipient-site preparation with fractional carbon dioxide laser versus dermabrasion and recipient-site dressing composition in melanocyte-keratinocyte transplantation procedure in vitiligo: a preliminary study [published online January 24, 2016]. Br J Dermatol. 2016;174:895-897.
NSAIDs work best in selected systemic JIA kids
BALTIMORE – Children with systemic juvenile idiopathic arthritis have the best odds for responding to initial treatment with a nonsteroidal anti-inflammatory drug if they are no older than 6 years old, have five or fewer involved joints, and have a serum level of C-reactive protein that is at or below 13 mg/dL, based on a review of 57 children with systemic juvenile idiopathic arthritis treated with these drugs at a single U.S. center during 2000-2014.
“We recommend a trial of NSAID [nonsteroidal anti-inflammatory drug] monotherapy for these patients with systemic juvenile idiopathic arthritis [JIA],” Dr. Anjali S. Sura said at the annual meeting of the Pediatric Academic Societies. A reasonable trial of NSAID monotherapy would last 6 weeks; if patients failed to adequately respond at the end of 6 weeks, it would be reasonable to switch to another of the first-line drugs recommended for children starting treatment for JIA, either a glucocorticoid or the biological agent anakinra (Kineret), said Dr. Sura, a pediatrician at the University of Michigan in Ann Arbor.
Initial treatment with a NSAID is preferred, even though it will probably work in only about a quarter of patients, because it generally has the best safety profile among these three options, Dr. Sura said in an interview. “If we can risk-stratify children with systemic JIA for NSAID therapy” using these three criteria, “then NSAID monotherapy may be more effective,” she explained.
The NSAIDs most commonly used to treat systemic JIA are naproxen or indomethacin, at anti-inflammatory dosages, which for naproxen is 15-20 mg/kg per day, and for indomethacin 3-4 mg/kg per day, she said.
But Dr. Sura also cautioned that the analysis she presented focused on a relatively small and selected group of children with systemic JIA who received initial NSAID monotherapy. The series she and her associates reviewed included 99 patients, of whom 57 received NSAID monotherapy; 35 of these patients were 6 years old or younger.
The researchers compared the 15 NSAID responders (26%), defined as patients who had clinically inactive disease, with the 42 nonresponders and identified the three clinical and demographic characteristics that occurred much more often among responders. The ideal candidates for initial NSAID monotherapy should fulfill all three criteria: age, number of affected joints, and serum level of C-reactive protein, Dr. Sura said in her report.
Dr. Sura noted that a panel of the American College of Rheumatology said that NSAIDs, glucocorticoids, and anakinra were equally good options for initial treatment of JIA in their 2013 update of JIA recommendations (Arthritis Rheum. 2013 Oct;65[10]:2499-512). This 2013 update excepted patients with no actively affected joints, whom the panel said should specifically receive an NSAID, and excepted patients with a high global severity score as rated by their physicians, whom the panel said should receive either a glucocorticoid or anakinra but not NSAID monotherapy. The European League Against Rheumatism has not issued recommendations for managing systemic JIA.
Dr. Sura had no disclosures.
On Twitter @mitchelzoler
BALTIMORE – Children with systemic juvenile idiopathic arthritis have the best odds for responding to initial treatment with a nonsteroidal anti-inflammatory drug if they are no older than 6 years old, have five or fewer involved joints, and have a serum level of C-reactive protein that is at or below 13 mg/dL, based on a review of 57 children with systemic juvenile idiopathic arthritis treated with these drugs at a single U.S. center during 2000-2014.
“We recommend a trial of NSAID [nonsteroidal anti-inflammatory drug] monotherapy for these patients with systemic juvenile idiopathic arthritis [JIA],” Dr. Anjali S. Sura said at the annual meeting of the Pediatric Academic Societies. A reasonable trial of NSAID monotherapy would last 6 weeks; if patients failed to adequately respond at the end of 6 weeks, it would be reasonable to switch to another of the first-line drugs recommended for children starting treatment for JIA, either a glucocorticoid or the biological agent anakinra (Kineret), said Dr. Sura, a pediatrician at the University of Michigan in Ann Arbor.
Initial treatment with a NSAID is preferred, even though it will probably work in only about a quarter of patients, because it generally has the best safety profile among these three options, Dr. Sura said in an interview. “If we can risk-stratify children with systemic JIA for NSAID therapy” using these three criteria, “then NSAID monotherapy may be more effective,” she explained.
The NSAIDs most commonly used to treat systemic JIA are naproxen or indomethacin, at anti-inflammatory dosages, which for naproxen is 15-20 mg/kg per day, and for indomethacin 3-4 mg/kg per day, she said.
But Dr. Sura also cautioned that the analysis she presented focused on a relatively small and selected group of children with systemic JIA who received initial NSAID monotherapy. The series she and her associates reviewed included 99 patients, of whom 57 received NSAID monotherapy; 35 of these patients were 6 years old or younger.
The researchers compared the 15 NSAID responders (26%), defined as patients who had clinically inactive disease, with the 42 nonresponders and identified the three clinical and demographic characteristics that occurred much more often among responders. The ideal candidates for initial NSAID monotherapy should fulfill all three criteria: age, number of affected joints, and serum level of C-reactive protein, Dr. Sura said in her report.
Dr. Sura noted that a panel of the American College of Rheumatology said that NSAIDs, glucocorticoids, and anakinra were equally good options for initial treatment of JIA in their 2013 update of JIA recommendations (Arthritis Rheum. 2013 Oct;65[10]:2499-512). This 2013 update excepted patients with no actively affected joints, whom the panel said should specifically receive an NSAID, and excepted patients with a high global severity score as rated by their physicians, whom the panel said should receive either a glucocorticoid or anakinra but not NSAID monotherapy. The European League Against Rheumatism has not issued recommendations for managing systemic JIA.
Dr. Sura had no disclosures.
On Twitter @mitchelzoler
BALTIMORE – Children with systemic juvenile idiopathic arthritis have the best odds for responding to initial treatment with a nonsteroidal anti-inflammatory drug if they are no older than 6 years old, have five or fewer involved joints, and have a serum level of C-reactive protein that is at or below 13 mg/dL, based on a review of 57 children with systemic juvenile idiopathic arthritis treated with these drugs at a single U.S. center during 2000-2014.
“We recommend a trial of NSAID [nonsteroidal anti-inflammatory drug] monotherapy for these patients with systemic juvenile idiopathic arthritis [JIA],” Dr. Anjali S. Sura said at the annual meeting of the Pediatric Academic Societies. A reasonable trial of NSAID monotherapy would last 6 weeks; if patients failed to adequately respond at the end of 6 weeks, it would be reasonable to switch to another of the first-line drugs recommended for children starting treatment for JIA, either a glucocorticoid or the biological agent anakinra (Kineret), said Dr. Sura, a pediatrician at the University of Michigan in Ann Arbor.
Initial treatment with a NSAID is preferred, even though it will probably work in only about a quarter of patients, because it generally has the best safety profile among these three options, Dr. Sura said in an interview. “If we can risk-stratify children with systemic JIA for NSAID therapy” using these three criteria, “then NSAID monotherapy may be more effective,” she explained.
The NSAIDs most commonly used to treat systemic JIA are naproxen or indomethacin, at anti-inflammatory dosages, which for naproxen is 15-20 mg/kg per day, and for indomethacin 3-4 mg/kg per day, she said.
But Dr. Sura also cautioned that the analysis she presented focused on a relatively small and selected group of children with systemic JIA who received initial NSAID monotherapy. The series she and her associates reviewed included 99 patients, of whom 57 received NSAID monotherapy; 35 of these patients were 6 years old or younger.
The researchers compared the 15 NSAID responders (26%), defined as patients who had clinically inactive disease, with the 42 nonresponders and identified the three clinical and demographic characteristics that occurred much more often among responders. The ideal candidates for initial NSAID monotherapy should fulfill all three criteria: age, number of affected joints, and serum level of C-reactive protein, Dr. Sura said in her report.
Dr. Sura noted that a panel of the American College of Rheumatology said that NSAIDs, glucocorticoids, and anakinra were equally good options for initial treatment of JIA in their 2013 update of JIA recommendations (Arthritis Rheum. 2013 Oct;65[10]:2499-512). This 2013 update excepted patients with no actively affected joints, whom the panel said should specifically receive an NSAID, and excepted patients with a high global severity score as rated by their physicians, whom the panel said should receive either a glucocorticoid or anakinra but not NSAID monotherapy. The European League Against Rheumatism has not issued recommendations for managing systemic JIA.
Dr. Sura had no disclosures.
On Twitter @mitchelzoler
AT THE PAS ANNUAL MEETING
Key clinical point: Three clinical parameters identified the children with systemic juvenile idiopathic arthritis who historically responded best to initial treatment with a nonsteroidal anti-inflammatory drug.
Major finding: Five or fewer involved joints, 6 years old or younger, and C-reactive protein of 13 mg/dL or less identified the best NSAID responders.
Data source: Review of 57 children with systemic juvenile idiopathic arthritis treated initially with NSAID monotherapy at one U.S. center.
Disclosures: Dr. Sura had no disclosures.
What standards do insurance companies hold themselves to?
My newest iteration of a VIP, or very ill patient, is a lovely middle-aged gentleman who has been sick for a year with a multisystem disorder. It started with severely swollen hands and feet along with significant anemia and fatigue. One year, many imaging studies, a couple of biopsies, and a latent tuberculosis infection later, he is still very sick. Throughout his ordeal he has often said to me: “You are the quarterback.” I’ve taken that to heart.
I don’t know why this surprises me, but insurance companies are being increasingly difficult. They’re passing more of the cost of health care to patients, and they’re less willing to cover medications and procedures. I have patients who can’t get physical therapy because they can’t afford the $45 copay for each visit. One patient stopped her hydroxychloroquine because it went from $4/month to $90/month. A couple of patients have opted not to take risedronate because the copay per month is $200 – that’s $200 for one generic pill.
At a recent morbidity and mortality conference, the attendees, nonrheumatologists all, were incredulous that cyclophosphamide, which has been around for ages and should be generic, is not covered by Medicare. Our patient with granulomatosis with polyangiitis and alveolar hemorrhage was on the hook for several hundred dollars per month, which he couldn’t afford.
Insurers also have been giving me more pushback for medications. For example, I recently tried to start one of my patients on etanercept for rheumatoid arthritis. His insurance company wrote to say etanercept was not their “preferred” first-line biologic. I explained that their preferred anti-TNF agents all carried the potential for developing anti-drug antibodies when used without methotrexate, which was contraindicated in my patient. They were unmoved.
I had a similar experience with my VIP. He was denied tocilizumab because he had not yet tried and failed two anti-TNF agents. I appealed the decision because I thought etanercept had caused a side effect that might be a class effect. To my surprise, rather than getting an approval, I received instead a request for medical literature to support my theory. Who knew that the decision-bots were so sophisticated?
Ultimately, I got the drug approved, but of course this process was an inconvenience to me, adding unnecessarily to the work of doctoring. More importantly, it was time wasted for my patient who was suffering tremendously.
My point is this: The idea of me as quarterback is quaint. Ultimately, it is the insurance company that dictates testing, treatment, physician, and facility.
There is an expectation that physicians are perfect, and we have internalized that expectation to some degree, holding ourselves to exacting standards, guided by what’s in the patient’s best interest. I want to know what sort of standards insurance companies hold themselves to, because I think they – out of all of us involved in health care – they who have the greatest resources should be absolutely unimpeachable.
Dr. Chan practices rheumatology in Pawtucket, R.I.
My newest iteration of a VIP, or very ill patient, is a lovely middle-aged gentleman who has been sick for a year with a multisystem disorder. It started with severely swollen hands and feet along with significant anemia and fatigue. One year, many imaging studies, a couple of biopsies, and a latent tuberculosis infection later, he is still very sick. Throughout his ordeal he has often said to me: “You are the quarterback.” I’ve taken that to heart.
I don’t know why this surprises me, but insurance companies are being increasingly difficult. They’re passing more of the cost of health care to patients, and they’re less willing to cover medications and procedures. I have patients who can’t get physical therapy because they can’t afford the $45 copay for each visit. One patient stopped her hydroxychloroquine because it went from $4/month to $90/month. A couple of patients have opted not to take risedronate because the copay per month is $200 – that’s $200 for one generic pill.
At a recent morbidity and mortality conference, the attendees, nonrheumatologists all, were incredulous that cyclophosphamide, which has been around for ages and should be generic, is not covered by Medicare. Our patient with granulomatosis with polyangiitis and alveolar hemorrhage was on the hook for several hundred dollars per month, which he couldn’t afford.
Insurers also have been giving me more pushback for medications. For example, I recently tried to start one of my patients on etanercept for rheumatoid arthritis. His insurance company wrote to say etanercept was not their “preferred” first-line biologic. I explained that their preferred anti-TNF agents all carried the potential for developing anti-drug antibodies when used without methotrexate, which was contraindicated in my patient. They were unmoved.
I had a similar experience with my VIP. He was denied tocilizumab because he had not yet tried and failed two anti-TNF agents. I appealed the decision because I thought etanercept had caused a side effect that might be a class effect. To my surprise, rather than getting an approval, I received instead a request for medical literature to support my theory. Who knew that the decision-bots were so sophisticated?
Ultimately, I got the drug approved, but of course this process was an inconvenience to me, adding unnecessarily to the work of doctoring. More importantly, it was time wasted for my patient who was suffering tremendously.
My point is this: The idea of me as quarterback is quaint. Ultimately, it is the insurance company that dictates testing, treatment, physician, and facility.
There is an expectation that physicians are perfect, and we have internalized that expectation to some degree, holding ourselves to exacting standards, guided by what’s in the patient’s best interest. I want to know what sort of standards insurance companies hold themselves to, because I think they – out of all of us involved in health care – they who have the greatest resources should be absolutely unimpeachable.
Dr. Chan practices rheumatology in Pawtucket, R.I.
My newest iteration of a VIP, or very ill patient, is a lovely middle-aged gentleman who has been sick for a year with a multisystem disorder. It started with severely swollen hands and feet along with significant anemia and fatigue. One year, many imaging studies, a couple of biopsies, and a latent tuberculosis infection later, he is still very sick. Throughout his ordeal he has often said to me: “You are the quarterback.” I’ve taken that to heart.
I don’t know why this surprises me, but insurance companies are being increasingly difficult. They’re passing more of the cost of health care to patients, and they’re less willing to cover medications and procedures. I have patients who can’t get physical therapy because they can’t afford the $45 copay for each visit. One patient stopped her hydroxychloroquine because it went from $4/month to $90/month. A couple of patients have opted not to take risedronate because the copay per month is $200 – that’s $200 for one generic pill.
At a recent morbidity and mortality conference, the attendees, nonrheumatologists all, were incredulous that cyclophosphamide, which has been around for ages and should be generic, is not covered by Medicare. Our patient with granulomatosis with polyangiitis and alveolar hemorrhage was on the hook for several hundred dollars per month, which he couldn’t afford.
Insurers also have been giving me more pushback for medications. For example, I recently tried to start one of my patients on etanercept for rheumatoid arthritis. His insurance company wrote to say etanercept was not their “preferred” first-line biologic. I explained that their preferred anti-TNF agents all carried the potential for developing anti-drug antibodies when used without methotrexate, which was contraindicated in my patient. They were unmoved.
I had a similar experience with my VIP. He was denied tocilizumab because he had not yet tried and failed two anti-TNF agents. I appealed the decision because I thought etanercept had caused a side effect that might be a class effect. To my surprise, rather than getting an approval, I received instead a request for medical literature to support my theory. Who knew that the decision-bots were so sophisticated?
Ultimately, I got the drug approved, but of course this process was an inconvenience to me, adding unnecessarily to the work of doctoring. More importantly, it was time wasted for my patient who was suffering tremendously.
My point is this: The idea of me as quarterback is quaint. Ultimately, it is the insurance company that dictates testing, treatment, physician, and facility.
There is an expectation that physicians are perfect, and we have internalized that expectation to some degree, holding ourselves to exacting standards, guided by what’s in the patient’s best interest. I want to know what sort of standards insurance companies hold themselves to, because I think they – out of all of us involved in health care – they who have the greatest resources should be absolutely unimpeachable.
Dr. Chan practices rheumatology in Pawtucket, R.I.
Epicardial GP ablation of no benefit in advanced atrial fibrillation
San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.
“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.
Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.
At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.
Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.
“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.
Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.
Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.
Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.
AF ablation is an evolving field, and we are constantly trying to think of new ways to improve our success rates. Some of the things we try turn out to be advantageous and others do not. Negative studies like this have a very important clinical impact; they help us figure out what road to take.
![]() |
Dr. Thomas Deering |
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. de Groot’s presentation, and wasn’t involved in the work.
AF ablation is an evolving field, and we are constantly trying to think of new ways to improve our success rates. Some of the things we try turn out to be advantageous and others do not. Negative studies like this have a very important clinical impact; they help us figure out what road to take.
![]() |
Dr. Thomas Deering |
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. de Groot’s presentation, and wasn’t involved in the work.
AF ablation is an evolving field, and we are constantly trying to think of new ways to improve our success rates. Some of the things we try turn out to be advantageous and others do not. Negative studies like this have a very important clinical impact; they help us figure out what road to take.
![]() |
Dr. Thomas Deering |
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. de Groot’s presentation, and wasn’t involved in the work.
San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.
“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.
Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.
At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.
Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.
“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.
Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.
Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.
Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.
San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.
“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.
Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.
At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.
Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.
“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.
Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.
Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.
Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.
AT HEART RHYTHM 2016
Key clinical point: Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation.
Major finding: At 1 year, 70.9% in the GP ablation group, but 68.4% in the control arm, were free of recurrence (P = .7)
Data source: Randomized trial of 240 AF patients, almost two-thirds with persistent disease
Disclosures: The lead investigator disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical, and research funding from AtriCure and St. Jude.
FDA publishes draft guidance for developing HCV antivirals
The U.S. Food and Drug Administration has issued revised draft guidance intended to foster the development of direct-acting antiviral drugs to treat chronic hepatitis C virus infection.
The guidance, developed by the FDA’s Center for Drug Evaluation and Research, delineates the drug development process from the preinvestigational new drug application through the new drug application and postmarketing stages.
According to the FDA, the draft guidance, when finalized, will represent the current thinking of the agency on development of direct-acting antivirals and clinical trial designs, but is not binding on the FDA or the public. It explicitly states that industry may use an alternative approach to drug development if it “satisfies the requirements of the applicable statutes and regulations.” For the purposes of drug development, the FDA defines direct-acting HCV antivirals as drugs that “interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV genome, polyprotein, or its polyprotein cleavage products.”
The guidance does not address the development of drugs that target host functions necessary for viral replication or immune-based drugs for the treatment of HCV infection, including new interferon drugs or therapeutics “without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes” of chronic HCV infection, such as prevention of hepatocellular carcinoma or reversal of fibrosis.
Once the draft guidance has been published in the Federal Register, the FDA will accept comments and suggestions at www.regulations.gov for 60 days.
On Twitter @richpizzi
The U.S. Food and Drug Administration has issued revised draft guidance intended to foster the development of direct-acting antiviral drugs to treat chronic hepatitis C virus infection.
The guidance, developed by the FDA’s Center for Drug Evaluation and Research, delineates the drug development process from the preinvestigational new drug application through the new drug application and postmarketing stages.
According to the FDA, the draft guidance, when finalized, will represent the current thinking of the agency on development of direct-acting antivirals and clinical trial designs, but is not binding on the FDA or the public. It explicitly states that industry may use an alternative approach to drug development if it “satisfies the requirements of the applicable statutes and regulations.” For the purposes of drug development, the FDA defines direct-acting HCV antivirals as drugs that “interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV genome, polyprotein, or its polyprotein cleavage products.”
The guidance does not address the development of drugs that target host functions necessary for viral replication or immune-based drugs for the treatment of HCV infection, including new interferon drugs or therapeutics “without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes” of chronic HCV infection, such as prevention of hepatocellular carcinoma or reversal of fibrosis.
Once the draft guidance has been published in the Federal Register, the FDA will accept comments and suggestions at www.regulations.gov for 60 days.
On Twitter @richpizzi
The U.S. Food and Drug Administration has issued revised draft guidance intended to foster the development of direct-acting antiviral drugs to treat chronic hepatitis C virus infection.
The guidance, developed by the FDA’s Center for Drug Evaluation and Research, delineates the drug development process from the preinvestigational new drug application through the new drug application and postmarketing stages.
According to the FDA, the draft guidance, when finalized, will represent the current thinking of the agency on development of direct-acting antivirals and clinical trial designs, but is not binding on the FDA or the public. It explicitly states that industry may use an alternative approach to drug development if it “satisfies the requirements of the applicable statutes and regulations.” For the purposes of drug development, the FDA defines direct-acting HCV antivirals as drugs that “interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV genome, polyprotein, or its polyprotein cleavage products.”
The guidance does not address the development of drugs that target host functions necessary for viral replication or immune-based drugs for the treatment of HCV infection, including new interferon drugs or therapeutics “without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes” of chronic HCV infection, such as prevention of hepatocellular carcinoma or reversal of fibrosis.
Once the draft guidance has been published in the Federal Register, the FDA will accept comments and suggestions at www.regulations.gov for 60 days.
On Twitter @richpizzi
Study: Number of MRSA cases in Japan may be underestimated
In Japan, sentinel disease surveillance systems may underestimate the actual number of patients with methicillin-resistant Staphylococcus aureus (MRSA) infection because they do not include information about patients who visit nonsentinel medical facilities, according to a study published in Epidemiology and Infection.
Dr. Shinichi Tanihara of the department of public health and preventive medicine in the School of Medicine at Fukuoka University and Dr. Satowa Suzuki of the department of bacteriology II at the National Institute of Infectious Diseases in Tokyo assessed and compared the incidences of MRSA patients based on health insurance claims data and data reported to the Japan Nosocomial Infections Surveillance system (Epidemiol Infect. 2016 April 8. doi: 10.1017/S0950268816000674).
The study results suggested that health insurance claims data for MRSA cases were more useful for determining the incidence of MRSA cases in Japan from 2011 to 2012. For example, of the 2,052 eligible hospitals with 200 or more beds in 2011, roughly one-quarter (495, 23.8%) participated in the Japan Nosocomial Infections Surveillance system. Data from this relatively low percentage of eligible facilities most likely underestimated the true number of MRSA patients in Japan, the authors said.
Based on their findings, the investigators noted three major advantages of using health insurance claims data for infection surveillance. Firstly, information from health insurance claims data is not affected by health care providers’ notifications to surveillance systems. Secondly, data on patients with MRSA can be collected at low cost because of Japan’s uniform and computerized health insurance system, and the data are easy to access. Lastly, health insurance claims data prevent the duplication of patient information, as insurers can determine if a patient was treated at multiple medical facilities for the same disease.
The only noted drawback involving the use of health insurance claims data for infection surveillance pertained to its timeliness, the researchers wrote. This issue arises because these data are submitted monthly rather than immediately, which may limit their use in surveillance systems.
According to Dr. Tanihara and Dr. Suzuki, strengths of the study include its evaluation of sentinel surveillance quality through the use of data that were not based on physician reports, as well as the calculation of MRSA incidence by use of a standardized definition in a specific population. Reported limitations included the assessment of anti-MRSA medicine use and patients’ age only, and the lack of information on the degree of drug resistance from health insurance claims data.
Funding was provided by the Ministry of Health, Labour, and Welfare of Japan, and by the Research Programme on Emerging and Re-emerging Infectious Diseases from the Japan Agency for Medical Research and Development. Neither author reported any conflicts of interest.
In Japan, sentinel disease surveillance systems may underestimate the actual number of patients with methicillin-resistant Staphylococcus aureus (MRSA) infection because they do not include information about patients who visit nonsentinel medical facilities, according to a study published in Epidemiology and Infection.
Dr. Shinichi Tanihara of the department of public health and preventive medicine in the School of Medicine at Fukuoka University and Dr. Satowa Suzuki of the department of bacteriology II at the National Institute of Infectious Diseases in Tokyo assessed and compared the incidences of MRSA patients based on health insurance claims data and data reported to the Japan Nosocomial Infections Surveillance system (Epidemiol Infect. 2016 April 8. doi: 10.1017/S0950268816000674).
The study results suggested that health insurance claims data for MRSA cases were more useful for determining the incidence of MRSA cases in Japan from 2011 to 2012. For example, of the 2,052 eligible hospitals with 200 or more beds in 2011, roughly one-quarter (495, 23.8%) participated in the Japan Nosocomial Infections Surveillance system. Data from this relatively low percentage of eligible facilities most likely underestimated the true number of MRSA patients in Japan, the authors said.
Based on their findings, the investigators noted three major advantages of using health insurance claims data for infection surveillance. Firstly, information from health insurance claims data is not affected by health care providers’ notifications to surveillance systems. Secondly, data on patients with MRSA can be collected at low cost because of Japan’s uniform and computerized health insurance system, and the data are easy to access. Lastly, health insurance claims data prevent the duplication of patient information, as insurers can determine if a patient was treated at multiple medical facilities for the same disease.
The only noted drawback involving the use of health insurance claims data for infection surveillance pertained to its timeliness, the researchers wrote. This issue arises because these data are submitted monthly rather than immediately, which may limit their use in surveillance systems.
According to Dr. Tanihara and Dr. Suzuki, strengths of the study include its evaluation of sentinel surveillance quality through the use of data that were not based on physician reports, as well as the calculation of MRSA incidence by use of a standardized definition in a specific population. Reported limitations included the assessment of anti-MRSA medicine use and patients’ age only, and the lack of information on the degree of drug resistance from health insurance claims data.
Funding was provided by the Ministry of Health, Labour, and Welfare of Japan, and by the Research Programme on Emerging and Re-emerging Infectious Diseases from the Japan Agency for Medical Research and Development. Neither author reported any conflicts of interest.
In Japan, sentinel disease surveillance systems may underestimate the actual number of patients with methicillin-resistant Staphylococcus aureus (MRSA) infection because they do not include information about patients who visit nonsentinel medical facilities, according to a study published in Epidemiology and Infection.
Dr. Shinichi Tanihara of the department of public health and preventive medicine in the School of Medicine at Fukuoka University and Dr. Satowa Suzuki of the department of bacteriology II at the National Institute of Infectious Diseases in Tokyo assessed and compared the incidences of MRSA patients based on health insurance claims data and data reported to the Japan Nosocomial Infections Surveillance system (Epidemiol Infect. 2016 April 8. doi: 10.1017/S0950268816000674).
The study results suggested that health insurance claims data for MRSA cases were more useful for determining the incidence of MRSA cases in Japan from 2011 to 2012. For example, of the 2,052 eligible hospitals with 200 or more beds in 2011, roughly one-quarter (495, 23.8%) participated in the Japan Nosocomial Infections Surveillance system. Data from this relatively low percentage of eligible facilities most likely underestimated the true number of MRSA patients in Japan, the authors said.
Based on their findings, the investigators noted three major advantages of using health insurance claims data for infection surveillance. Firstly, information from health insurance claims data is not affected by health care providers’ notifications to surveillance systems. Secondly, data on patients with MRSA can be collected at low cost because of Japan’s uniform and computerized health insurance system, and the data are easy to access. Lastly, health insurance claims data prevent the duplication of patient information, as insurers can determine if a patient was treated at multiple medical facilities for the same disease.
The only noted drawback involving the use of health insurance claims data for infection surveillance pertained to its timeliness, the researchers wrote. This issue arises because these data are submitted monthly rather than immediately, which may limit their use in surveillance systems.
According to Dr. Tanihara and Dr. Suzuki, strengths of the study include its evaluation of sentinel surveillance quality through the use of data that were not based on physician reports, as well as the calculation of MRSA incidence by use of a standardized definition in a specific population. Reported limitations included the assessment of anti-MRSA medicine use and patients’ age only, and the lack of information on the degree of drug resistance from health insurance claims data.
Funding was provided by the Ministry of Health, Labour, and Welfare of Japan, and by the Research Programme on Emerging and Re-emerging Infectious Diseases from the Japan Agency for Medical Research and Development. Neither author reported any conflicts of interest.
Key clinical point: Sentinel surveillance systems may substantially underestimate the number of methicillin-resistant Staphylococcus aureus cases in Japan.
Major finding: Direct notification to the Japan Nosocomial Infections Surveillance system regarding methicillin-resistant Staphylococcus aureus patients was not affected by patients’ age, and information from health insurance claims was useful for evaluation of the sentinel infection surveillance system.
Data sources: The Japan Nosocomial Infections Surveillance system and the National Health Insurance Organization.
Disclosures: Funding was provided by the Ministry of Health, Labour, and Welfare of Japan, and by the Research Programme on Emerging and Re-emerging Infectious Diseases from the Japan Agency for Medical Research and Development. Neither author reported any conflicts of interest.