Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

 

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

 

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

 

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

 

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

 

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

 

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

 

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

 

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

 

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

 

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a 5-to-4 decision issued June 26, the majority justices wrote that California cannot force the anti-abortion centers to post notices about obtaining abortions, comparing the requirement to a “government-drafted script” that forces the centers to give information about the very service they oppose. The justices sent the case back to the lower court for another assessment in light of their ruling.

The ruling protects people from being forced to express a message that violates their beliefs, said Michael Farris, president for Alliance Defending Freedom and counsel for the National Institute of Family and Life Advocates (NIFLA), the lead plaintiff.

“In this case, the government used its power to force pro-life pregnancy centers to provide free advertising for abortion,” Mr. Farris said in a statement. “The Supreme Court said that the government can’t do that and that it must respect pro-life beliefs. Tolerance and respect for good-faith differences of opinion are essential in a diverse society like ours. They enable us to coexist peacefully with one another. If we want to have freedom for ourselves, we have to extend it to others.”

California Attorney General Xavier Becerra expressed disappointment at the Supreme Court’s decision, saying the opinion complicates the state’s efforts to empower women with information about their health care.

“When it comes to making their health decisions, all California women – regardless of their economic background or zip code – deserve access to critical and nonbiased information to make their own informed decisions,” Mr. Becerra said in a statement. The “ruling is unfortunate, but our work to ensure that Californians receive accurate information about their health care options will continue.”

The legal challenge began after California passed its 2016 Reproductive Freedom, Accountability, Comprehensive Care, and Transparency (FACT) Act, which requires that pregnancy centers – many of which are anti-abortion – post notices about where patients can find free or low-cost abortion services. Another part of the law requires unlicensed pregnancy centers to disclose to women that they are not a licensed medical facility and have no medical professionals on staff.

The plaintiffs, led by the nonprofit NIFLA, argued that the law violated the First Amendment by requiring speech and because the measure unfairly targets centers that discourage abortions. California officials contended that the law was needed to address concerns that nonprofit organizations, often religious, were misrepresenting themselves as full-service reproductive health clinics and misleading women about their options.

However, in the court’s majority opinion, Associate Justice Clarence Thomas wrote that California can inform women about abortion services through other means, such as advertising, rather than burdening the plaintiffs with compelled speech.

“California cannot co-opt the licensed facilities to deliver its message for it,” he wrote. The “First Amendment does not permit the state to sacrifice speech for efficiency.”

 

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

“[The doctrine has] been used in Florida to try to prevent doctors from asking their patients whether they owned guns,” Mr. McNamara. “It had been used in Texas to stop a veterinarian from emailing people pet-care advice. After yesterday’s decision, it is clear that doctors did not sacrifice their free-speech rights when they went to medical school, and that should be cause for celebration regardless of whether one agrees with the worldview of the pregnancy centers who brought the NIFLA case.”

However, Heather Shumaker, senior counsel for reproductive rights and health at the National Women’s Law Center, said the ruling is detrimental to patients’ health care and chills their access to truthful, accurate medical information.

“Throughout the country, anti-abortion counseling centers provide false, misleading, or incomplete information, and frighten and coerce women to make certain decisions about their health care options,” Ms. Shumaker said in an interview. “This deception endangers women’s health and future fertility, and particularly burdens women of color and women struggling to make ends meet. It is devastating that [the] decision will make access to full reproductive health care more difficult.”

The American College of Obstetricians and Gynecologists (ACOG) also expressed disappointment at the Supreme Court’s ruling.

“Pregnant women who seek medical guidance must be able to trust that information being provided to them is truthful, medically accurate, and enables them to make informed decisions about their care,” ACOG President Lisa Hollier, MD, said in a statement. “Inaccurate and untruthful information can delay care and increase risk of medical complications.”

 

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a 5-to-4 decision issued June 26, the majority justices wrote that California cannot force the anti-abortion centers to post notices about obtaining abortions, comparing the requirement to a “government-drafted script” that forces the centers to give information about the very service they oppose. The justices sent the case back to the lower court for another assessment in light of their ruling.

The ruling protects people from being forced to express a message that violates their beliefs, said Michael Farris, president for Alliance Defending Freedom and counsel for the National Institute of Family and Life Advocates (NIFLA), the lead plaintiff.

“In this case, the government used its power to force pro-life pregnancy centers to provide free advertising for abortion,” Mr. Farris said in a statement. “The Supreme Court said that the government can’t do that and that it must respect pro-life beliefs. Tolerance and respect for good-faith differences of opinion are essential in a diverse society like ours. They enable us to coexist peacefully with one another. If we want to have freedom for ourselves, we have to extend it to others.”

California Attorney General Xavier Becerra expressed disappointment at the Supreme Court’s decision, saying the opinion complicates the state’s efforts to empower women with information about their health care.

“When it comes to making their health decisions, all California women – regardless of their economic background or zip code – deserve access to critical and nonbiased information to make their own informed decisions,” Mr. Becerra said in a statement. The “ruling is unfortunate, but our work to ensure that Californians receive accurate information about their health care options will continue.”

The legal challenge began after California passed its 2016 Reproductive Freedom, Accountability, Comprehensive Care, and Transparency (FACT) Act, which requires that pregnancy centers – many of which are anti-abortion – post notices about where patients can find free or low-cost abortion services. Another part of the law requires unlicensed pregnancy centers to disclose to women that they are not a licensed medical facility and have no medical professionals on staff.

The plaintiffs, led by the nonprofit NIFLA, argued that the law violated the First Amendment by requiring speech and because the measure unfairly targets centers that discourage abortions. California officials contended that the law was needed to address concerns that nonprofit organizations, often religious, were misrepresenting themselves as full-service reproductive health clinics and misleading women about their options.

However, in the court’s majority opinion, Associate Justice Clarence Thomas wrote that California can inform women about abortion services through other means, such as advertising, rather than burdening the plaintiffs with compelled speech.

“California cannot co-opt the licensed facilities to deliver its message for it,” he wrote. The “First Amendment does not permit the state to sacrifice speech for efficiency.”

 

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

“[The doctrine has] been used in Florida to try to prevent doctors from asking their patients whether they owned guns,” Mr. McNamara. “It had been used in Texas to stop a veterinarian from emailing people pet-care advice. After yesterday’s decision, it is clear that doctors did not sacrifice their free-speech rights when they went to medical school, and that should be cause for celebration regardless of whether one agrees with the worldview of the pregnancy centers who brought the NIFLA case.”

However, Heather Shumaker, senior counsel for reproductive rights and health at the National Women’s Law Center, said the ruling is detrimental to patients’ health care and chills their access to truthful, accurate medical information.

“Throughout the country, anti-abortion counseling centers provide false, misleading, or incomplete information, and frighten and coerce women to make certain decisions about their health care options,” Ms. Shumaker said in an interview. “This deception endangers women’s health and future fertility, and particularly burdens women of color and women struggling to make ends meet. It is devastating that [the] decision will make access to full reproductive health care more difficult.”

The American College of Obstetricians and Gynecologists (ACOG) also expressed disappointment at the Supreme Court’s ruling.

“Pregnant women who seek medical guidance must be able to trust that information being provided to them is truthful, medically accurate, and enables them to make informed decisions about their care,” ACOG President Lisa Hollier, MD, said in a statement. “Inaccurate and untruthful information can delay care and increase risk of medical complications.”

 

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a 5-to-4 decision issued June 26, the majority justices wrote that California cannot force the anti-abortion centers to post notices about obtaining abortions, comparing the requirement to a “government-drafted script” that forces the centers to give information about the very service they oppose. The justices sent the case back to the lower court for another assessment in light of their ruling.

The ruling protects people from being forced to express a message that violates their beliefs, said Michael Farris, president for Alliance Defending Freedom and counsel for the National Institute of Family and Life Advocates (NIFLA), the lead plaintiff.

“In this case, the government used its power to force pro-life pregnancy centers to provide free advertising for abortion,” Mr. Farris said in a statement. “The Supreme Court said that the government can’t do that and that it must respect pro-life beliefs. Tolerance and respect for good-faith differences of opinion are essential in a diverse society like ours. They enable us to coexist peacefully with one another. If we want to have freedom for ourselves, we have to extend it to others.”

California Attorney General Xavier Becerra expressed disappointment at the Supreme Court’s decision, saying the opinion complicates the state’s efforts to empower women with information about their health care.

“When it comes to making their health decisions, all California women – regardless of their economic background or zip code – deserve access to critical and nonbiased information to make their own informed decisions,” Mr. Becerra said in a statement. The “ruling is unfortunate, but our work to ensure that Californians receive accurate information about their health care options will continue.”

The legal challenge began after California passed its 2016 Reproductive Freedom, Accountability, Comprehensive Care, and Transparency (FACT) Act, which requires that pregnancy centers – many of which are anti-abortion – post notices about where patients can find free or low-cost abortion services. Another part of the law requires unlicensed pregnancy centers to disclose to women that they are not a licensed medical facility and have no medical professionals on staff.

The plaintiffs, led by the nonprofit NIFLA, argued that the law violated the First Amendment by requiring speech and because the measure unfairly targets centers that discourage abortions. California officials contended that the law was needed to address concerns that nonprofit organizations, often religious, were misrepresenting themselves as full-service reproductive health clinics and misleading women about their options.

However, in the court’s majority opinion, Associate Justice Clarence Thomas wrote that California can inform women about abortion services through other means, such as advertising, rather than burdening the plaintiffs with compelled speech.

“California cannot co-opt the licensed facilities to deliver its message for it,” he wrote. The “First Amendment does not permit the state to sacrifice speech for efficiency.”

 

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

“[The doctrine has] been used in Florida to try to prevent doctors from asking their patients whether they owned guns,” Mr. McNamara. “It had been used in Texas to stop a veterinarian from emailing people pet-care advice. After yesterday’s decision, it is clear that doctors did not sacrifice their free-speech rights when they went to medical school, and that should be cause for celebration regardless of whether one agrees with the worldview of the pregnancy centers who brought the NIFLA case.”

However, Heather Shumaker, senior counsel for reproductive rights and health at the National Women’s Law Center, said the ruling is detrimental to patients’ health care and chills their access to truthful, accurate medical information.

“Throughout the country, anti-abortion counseling centers provide false, misleading, or incomplete information, and frighten and coerce women to make certain decisions about their health care options,” Ms. Shumaker said in an interview. “This deception endangers women’s health and future fertility, and particularly burdens women of color and women struggling to make ends meet. It is devastating that [the] decision will make access to full reproductive health care more difficult.”

The American College of Obstetricians and Gynecologists (ACOG) also expressed disappointment at the Supreme Court’s ruling.

“Pregnant women who seek medical guidance must be able to trust that information being provided to them is truthful, medically accurate, and enables them to make informed decisions about their care,” ACOG President Lisa Hollier, MD, said in a statement. “Inaccurate and untruthful information can delay care and increase risk of medical complications.”

 

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

 

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

 

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

Patient characteristics
	Ropeg		HU
	<60 years (n=49)	≥60 years (n=46)	<60 years (n=39)	≥60 years (n=37)
Median age (range)	51 (30-59)	64 (60-85)	50 (32-59)	66 (61-79)
Median duration of PV (range)	1.9 months (0-145.5)	1.7 months (0.1-102.4)	1.6 months (0-91.6)	1.7 months (0-65.6)
HU pretreatment	17 (34.7%)	14 (30.4%)	12 (30.8%)	13 (35.1%)
Mean duration of HU treatment	11.3 months	14.8 months	16.0 months	11.2 months
Mean JAK2V617F allele burden	38.4%	47.4%	38.1%	48.1%
Splenomegaly present	2 (4.1%)	5 (10.9%)	4 (10.3%)	4 (10.8%)
Disease-related symptoms present	5 (10.2%)	10 (21.7%)	4 (10.3%)	13 (35.1%)

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

 

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

Safety results at a mean of 2.7 years of treatment (up to 3.6 years)
	Ropeg		HU
	<60 (n=49)	≥60 (n=46)	<60 (n=39)	≥60 (n=37)
Patients with any AE	44 (89.8%)	43 (93.5%)	36 (92.3%)	34 (91.1%)
Serious AE	3 (6.1%)	10 (21.7%)	4 (10.3%)	9 (24.3%)
ADR	38 (77.6%)	29 (63%)	29 (74.4%)	33 (89.2%)
Serious ADR	0	0	0	4 (10.8%)
Grade 3+ AE	10 (20.4%)	16 (34.8%)	10 (25.6%)	14 (37.8%)
Recovered from AE	43 (87.8%)	40 (87%)	35 (89.7%)	34 (91.9%)

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

Patient characteristics
	Ropeg		HU
	<60 years (n=49)	≥60 years (n=46)	<60 years (n=39)	≥60 years (n=37)
Median age (range)	51 (30-59)	64 (60-85)	50 (32-59)	66 (61-79)
Median duration of PV (range)	1.9 months (0-145.5)	1.7 months (0.1-102.4)	1.6 months (0-91.6)	1.7 months (0-65.6)
HU pretreatment	17 (34.7%)	14 (30.4%)	12 (30.8%)	13 (35.1%)
Mean duration of HU treatment	11.3 months	14.8 months	16.0 months	11.2 months
Mean JAK2V617F allele burden	38.4%	47.4%	38.1%	48.1%
Splenomegaly present	2 (4.1%)	5 (10.9%)	4 (10.3%)	4 (10.8%)
Disease-related symptoms present	5 (10.2%)	10 (21.7%)	4 (10.3%)	13 (35.1%)

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

 

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

Safety results at a mean of 2.7 years of treatment (up to 3.6 years)
	Ropeg		HU
	<60 (n=49)	≥60 (n=46)	<60 (n=39)	≥60 (n=37)
Patients with any AE	44 (89.8%)	43 (93.5%)	36 (92.3%)	34 (91.1%)
Serious AE	3 (6.1%)	10 (21.7%)	4 (10.3%)	9 (24.3%)
ADR	38 (77.6%)	29 (63%)	29 (74.4%)	33 (89.2%)
Serious ADR	0	0	0	4 (10.8%)
Grade 3+ AE	10 (20.4%)	16 (34.8%)	10 (25.6%)	14 (37.8%)
Recovered from AE	43 (87.8%)	40 (87%)	35 (89.7%)	34 (91.9%)

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

Patient characteristics
	Ropeg		HU
	<60 years (n=49)	≥60 years (n=46)	<60 years (n=39)	≥60 years (n=37)
Median age (range)	51 (30-59)	64 (60-85)	50 (32-59)	66 (61-79)
Median duration of PV (range)	1.9 months (0-145.5)	1.7 months (0.1-102.4)	1.6 months (0-91.6)	1.7 months (0-65.6)
HU pretreatment	17 (34.7%)	14 (30.4%)	12 (30.8%)	13 (35.1%)
Mean duration of HU treatment	11.3 months	14.8 months	16.0 months	11.2 months
Mean JAK2V617F allele burden	38.4%	47.4%	38.1%	48.1%
Splenomegaly present	2 (4.1%)	5 (10.9%)	4 (10.3%)	4 (10.8%)
Disease-related symptoms present	5 (10.2%)	10 (21.7%)	4 (10.3%)	13 (35.1%)

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

 

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

Safety results at a mean of 2.7 years of treatment (up to 3.6 years)
	Ropeg		HU
	<60 (n=49)	≥60 (n=46)	<60 (n=39)	≥60 (n=37)
Patients with any AE	44 (89.8%)	43 (93.5%)	36 (92.3%)	34 (91.1%)
Serious AE	3 (6.1%)	10 (21.7%)	4 (10.3%)	9 (24.3%)
ADR	38 (77.6%)	29 (63%)	29 (74.4%)	33 (89.2%)
Serious ADR	0	0	0	4 (10.8%)
Grade 3+ AE	10 (20.4%)	16 (34.8%)	10 (25.6%)	14 (37.8%)
Recovered from AE	43 (87.8%)	40 (87%)	35 (89.7%)	34 (91.9%)

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

In secondary outcome analyses, patients in the hydrocortisone group had faster resolution of shock (3 vs. 4 days; P less than .001) and a shorter duration of initial mechanical ventilation (6 vs. 7 days; P less than .001), and fewer patients received blood transfusions (37.0% vs. 41.7%; P = .004). There was no difference in mortality at 28 days, recurrence of shock, number of days alive out of the ICU and hospital, recurrence of mechanical ventilation, rate of renal replacement therapy, and incidence of new-onset bacteremia or fungemia.

Bottom line: Administering hydrocortisone in patients with septic shock who are undergoing mechanical ventilation does not reduce 90-day mortality.

Citation: Venkatesh B et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018 Jan 19. doi: 10.1056/NEJMoa1705835.

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

In secondary outcome analyses, patients in the hydrocortisone group had faster resolution of shock (3 vs. 4 days; P less than .001) and a shorter duration of initial mechanical ventilation (6 vs. 7 days; P less than .001), and fewer patients received blood transfusions (37.0% vs. 41.7%; P = .004). There was no difference in mortality at 28 days, recurrence of shock, number of days alive out of the ICU and hospital, recurrence of mechanical ventilation, rate of renal replacement therapy, and incidence of new-onset bacteremia or fungemia.

Bottom line: Administering hydrocortisone in patients with septic shock who are undergoing mechanical ventilation does not reduce 90-day mortality.

Citation: Venkatesh B et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018 Jan 19. doi: 10.1056/NEJMoa1705835.

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

In secondary outcome analyses, patients in the hydrocortisone group had faster resolution of shock (3 vs. 4 days; P less than .001) and a shorter duration of initial mechanical ventilation (6 vs. 7 days; P less than .001), and fewer patients received blood transfusions (37.0% vs. 41.7%; P = .004). There was no difference in mortality at 28 days, recurrence of shock, number of days alive out of the ICU and hospital, recurrence of mechanical ventilation, rate of renal replacement therapy, and incidence of new-onset bacteremia or fungemia.

Bottom line: Administering hydrocortisone in patients with septic shock who are undergoing mechanical ventilation does not reduce 90-day mortality.

Citation: Venkatesh B et al. Adjunctive glucocorticoid therapy in patients with septic shock. N Engl J Med. 2018 Jan 19. doi: 10.1056/NEJMoa1705835.

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.

 

The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.

The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).

Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.

The full prescribing information for encorafenib and binimetinib can be found on the FDA website.






 

 

The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.

The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).

Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.

The full prescribing information for encorafenib and binimetinib can be found on the FDA website.






 

 

The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.

The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).

Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.

The full prescribing information for encorafenib and binimetinib can be found on the FDA website.






 

 

SAN DIEGO – Between 1999 and 2015, heroin use increased among high school students who live in Milwaukee, Chicago, and New York – trends that accompanied a rise in injection drug use in those cities.

“This implies that a subset of these students who are using heroin are probably injecting heroin as well; otherwise these trends wouldn’t be mirroring each other so well,” lead study author Sherri-Chanelle Brighthaupt said in an interview at the annual meeting of the College on Problems of Drug Dependence.

Doug Brunk/MDedge News

The finding comes from a trend analysis of heroin use and injection drug use in nine urban U.S. school districts drawn from Youth Risk Behavior Survey (YRBS) data from 1999-2015. The analysis was conducted using data from New York City, three Florida counties (Broward, Orange, and Miami-Dade), Dallas, Chicago, Milwaukee, and two California cities (San Diego and San Bernardino). “This is one of the first studies we know of that’s looking at adolescent heroin and injection drug use at the local level,” said Ms. Brighthaupt, a third-year doctoral student in the department of mental health at Johns Hopkins University, Baltimore. “National estimates may mask variation at the local level.”

The sample population studied included local-level YRBS responses from 260,952 students in grades 9-12. All responses were weighted by sex, grade, and race/ethnicity, and the researchers used logistic regression models to test for liner and quadratic trends in the pooled sample and in each city. Between 1999 and 2015, lifetime heroin use among this population increased significantly, from 2.8% to 7.4% in Milwaukee (P = .0001), from 3.1% to 4.1% in Chicago (P = .02), and from 1% to 2.5% in New York (P less than .0001). However, during the same time frame, heroin use decreased in San Bernardino from 4.6% to 1.6% (P = .0001).

The researchers also found that between 1999 and 2015, lifetime injection drug use in this age group increased significantly, from 0.8% to 2.2% in New York (P less than .0001) and from 2.5% to 2.7% in Chicago (P = .05). During the same time period, lifetime injection drug use decreased in San Bernardino, (from 2.5% to 1.9%; P = .05) and in Dallas after peaking in 2007 (from 3.6% to 1%; P = .02).

“The take-home message is to look locally,” Ms. Brighthaupt said. “Some cities may have a historically entrenched culture of heroin use, and prevention and intervention efforts should be tailored to the unique social and cultural context of the geographic region.”

The research was supported by grants from the National Institute on Drug Abuse. Ms. Brighthaupt reported having no financial disclosures.

dbrunk@mdedge.com

 

SAN DIEGO – Between 1999 and 2015, heroin use increased among high school students who live in Milwaukee, Chicago, and New York – trends that accompanied a rise in injection drug use in those cities.

“This implies that a subset of these students who are using heroin are probably injecting heroin as well; otherwise these trends wouldn’t be mirroring each other so well,” lead study author Sherri-Chanelle Brighthaupt said in an interview at the annual meeting of the College on Problems of Drug Dependence.

Doug Brunk/MDedge News

The finding comes from a trend analysis of heroin use and injection drug use in nine urban U.S. school districts drawn from Youth Risk Behavior Survey (YRBS) data from 1999-2015. The analysis was conducted using data from New York City, three Florida counties (Broward, Orange, and Miami-Dade), Dallas, Chicago, Milwaukee, and two California cities (San Diego and San Bernardino). “This is one of the first studies we know of that’s looking at adolescent heroin and injection drug use at the local level,” said Ms. Brighthaupt, a third-year doctoral student in the department of mental health at Johns Hopkins University, Baltimore. “National estimates may mask variation at the local level.”

The sample population studied included local-level YRBS responses from 260,952 students in grades 9-12. All responses were weighted by sex, grade, and race/ethnicity, and the researchers used logistic regression models to test for liner and quadratic trends in the pooled sample and in each city. Between 1999 and 2015, lifetime heroin use among this population increased significantly, from 2.8% to 7.4% in Milwaukee (P = .0001), from 3.1% to 4.1% in Chicago (P = .02), and from 1% to 2.5% in New York (P less than .0001). However, during the same time frame, heroin use decreased in San Bernardino from 4.6% to 1.6% (P = .0001).

The researchers also found that between 1999 and 2015, lifetime injection drug use in this age group increased significantly, from 0.8% to 2.2% in New York (P less than .0001) and from 2.5% to 2.7% in Chicago (P = .05). During the same time period, lifetime injection drug use decreased in San Bernardino, (from 2.5% to 1.9%; P = .05) and in Dallas after peaking in 2007 (from 3.6% to 1%; P = .02).

“The take-home message is to look locally,” Ms. Brighthaupt said. “Some cities may have a historically entrenched culture of heroin use, and prevention and intervention efforts should be tailored to the unique social and cultural context of the geographic region.”

The research was supported by grants from the National Institute on Drug Abuse. Ms. Brighthaupt reported having no financial disclosures.

dbrunk@mdedge.com

 

SAN DIEGO – Between 1999 and 2015, heroin use increased among high school students who live in Milwaukee, Chicago, and New York – trends that accompanied a rise in injection drug use in those cities.

“This implies that a subset of these students who are using heroin are probably injecting heroin as well; otherwise these trends wouldn’t be mirroring each other so well,” lead study author Sherri-Chanelle Brighthaupt said in an interview at the annual meeting of the College on Problems of Drug Dependence.

Doug Brunk/MDedge News

The finding comes from a trend analysis of heroin use and injection drug use in nine urban U.S. school districts drawn from Youth Risk Behavior Survey (YRBS) data from 1999-2015. The analysis was conducted using data from New York City, three Florida counties (Broward, Orange, and Miami-Dade), Dallas, Chicago, Milwaukee, and two California cities (San Diego and San Bernardino). “This is one of the first studies we know of that’s looking at adolescent heroin and injection drug use at the local level,” said Ms. Brighthaupt, a third-year doctoral student in the department of mental health at Johns Hopkins University, Baltimore. “National estimates may mask variation at the local level.”

The sample population studied included local-level YRBS responses from 260,952 students in grades 9-12. All responses were weighted by sex, grade, and race/ethnicity, and the researchers used logistic regression models to test for liner and quadratic trends in the pooled sample and in each city. Between 1999 and 2015, lifetime heroin use among this population increased significantly, from 2.8% to 7.4% in Milwaukee (P = .0001), from 3.1% to 4.1% in Chicago (P = .02), and from 1% to 2.5% in New York (P less than .0001). However, during the same time frame, heroin use decreased in San Bernardino from 4.6% to 1.6% (P = .0001).

The researchers also found that between 1999 and 2015, lifetime injection drug use in this age group increased significantly, from 0.8% to 2.2% in New York (P less than .0001) and from 2.5% to 2.7% in Chicago (P = .05). During the same time period, lifetime injection drug use decreased in San Bernardino, (from 2.5% to 1.9%; P = .05) and in Dallas after peaking in 2007 (from 3.6% to 1%; P = .02).

“The take-home message is to look locally,” Ms. Brighthaupt said. “Some cities may have a historically entrenched culture of heroin use, and prevention and intervention efforts should be tailored to the unique social and cultural context of the geographic region.”

The research was supported by grants from the National Institute on Drug Abuse. Ms. Brighthaupt reported having no financial disclosures.

dbrunk@mdedge.com