Christine Kilgore

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation (pdf) and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation (pdf) and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

Dr. Stefan J. Friedrichsdorf has a list of "myths" about pediatric palliative care that he presents during lectures. Among them: that the death of a child in the United States is a rare event, that pediatric palliative care is just for children with cancer, and that care starts when treatment stops.

In his lectures – and in his work every day at Children’s Hospitals and Clinics of Minnesota, Minneapolis – Dr. Friedrichsdorf debunks these myths.

Photo credit: WFUBMC Photography

In January, he was one of two pediatricians who won national awards from the Hastings Center and a partnering foundation for their contributions to the broader field of palliative care. He and pediatrician Dr. Savithri Nageswaran of Brenner Children’s Hospital at Wake Forest University Baptist Medical Center in Winston-Salem, N.C., joined two geriatricians and an internist in receiving the award.

The pain and palliative care program at Dr. Friedrichsdorf’s institution is a relatively long-standing program, but pediatric palliative care is a new subspecialty and is still a relatively new area of pediatric care and of palliative medicine – one for which delivery models and educational pathways are still evolving, and one for which reimbursement is poor and regulatory barriers are challenging.

"It’s truly interdisciplinary, in that people need to really go beyond what they’ve been trained for," said Dr. Friedrichsdorf, medical director of the department of pain medicine, palliative care & integrative medicine at Children’s. "I’m nothing without my team."

Pediatric palliative care has been defined and described by the World Health Organization, the Institute of Medicine, the American Academy of Pediatrics, and other bodies as individualized, integrative care that is provided for children with life-threatening conditions. The care starts at diagnosis, continues through the trajectory of the illness, and is directed at the underlying illness and at the physical, emotional, social, and spiritual needs of the child and family.

More than 15,000 children and teens die in the United States each year from life-limiting diseases – and less than a quarter of them have cancer, according to data cited by Dr. Friedrichsdorf. Neuromuscular or neurodegenerative disorders cause a significant proportion of those deaths, followed by congenital or genetic disorders, cardiovascular disorders, and metabolic disorders.

"The vast majority of these children do not have access to pediatric palliative care in this country," Dr. Friedrichsdorf said in an interview. Data show that these children are suffering needlessly from pain, breathlessness, nausea, and vomiting.

Praised by the awards committee for "innovative symptom management, compassion, and family-centered care," Dr. Friedrichsdorf said he and his team take "an extremely aggressive approach" to managing pain and distressing symptoms in children with either life-threatening or life-limiting conditions.

He believes strong pain medications are underused in children (and one of the "myths" he debunks is that increasing doses of opioids and/or benzodiazepines causes respiratory depression and quickens death), but also that pharmacology alone is insufficient.

His department employs both pharmacology and complementary therapies such as biofeedback, massage, hypnosis, acupuncture, and acupressure. Physicians and other staff are trained in such modalities. "It’s not one or the other. It’s using the whole breadth [of therapies] at the same moment," said Dr. Friedrichsdorf, who is trained in self-hypnosis.

"We want to promise each family, if your child is suffering from distressing symptoms like nausea, pain, or dyspnea, we can usually make these symptoms go away," he said. "Our goal is for children to live as long as possible, as well as possible."

In addition to physicians and nurses, the pain and palliative care team at Children’s includes social workers, psychologists, a physical therapist, a child-life specialist, massage therapists, and advanced practice nurses.

Each of these professionals can see patients as part of a hospital-based pain and palliative care "rounding team" in the department’s pain and palliative care clinic, or for patients in the Minneapolis/St. Paul area, in the home through the department’s home-based component. The team can be called upon by anyone – a doctor, a patient, a relative or friend – for a consultation, and its members meet regularly to discuss patients.

"My physical therapist may tell me, for instance, that I need to change [a patient’s] pain medications because she sees side effects," Dr. Friedrichsdorf said.

A pilot study of pediatric palliative care teams at eight children’s hospitals, to be published soon, found that professionals in the teams had a "clear idea of what the other professionals offered to the patient and family," said Nancy Berlinger, Ph.D., deputy director and research scholar at the Hastings Center, which conducted the study with researchers at Rush University, Chicago.

A chaplain knows, for instance, how the physician and nurse are addressing the patient’s medical needs, and the physician is aware that the chaplain is supporting the parents and, in some cases, the child, she said in an interview.

"Having shared goals of care and strong communication is also important so that everything doesn’t have to be explained every time a shift changes or a patient is transferred to a different setting," she said.

"Most of these pediatric palliative care teams are fairly newly established," she noted. "There was some pediatric palliative care before then, but not necessarily with a strong team approach."

Dr. Nageswaran, who led the establishment of the first pediatric palliative care program at her hospital in 2008, said she was struck by the amount of coordination needed to provide good palliative care and by the flexibility needed to design a good program.

She and her colleagues started the program as a consult service for children who were hospitalized with complicated, often life-limiting conditions. The service used a half-time nurse coordinator, a one-quarter full-time equivalent (FTE) clinician post to be shared by a handful of physicians for rotating on-call duty, and a 1% FTE post for a physician coordinator.

"Very soon, we realized that the biggest need was to facilitate collaboration between multiple providers and to ensure sufficient continuity of care as these children transition back and forth from the hospital to home," Dr. Nageswaran said in an interview. "We weren’t achieving this with the traditional consult model where we’d see patients in the hospital and leave recommendations for the primary medical team."

In a subsequent restructuring, physician time was consolidated into a one-third–time FTE coordinator post, which Dr. Nageswaran fills herself, and funding was obtained from the federal Maternal and Child Health Bureau to add another half-time nurse coordinator who could focus on making home visits and coordinating home-based care in one local county.

The flexibility to coordinate care outside the hospital is critical, Dr. Nageswaran said. One of the 235 children cared for under the palliative care program thus far was a child with a rare genetic disorder characterized by skeletal abnormalities, urologic abnormalities, and severe neurologic impairment and seizures.

"The family wanted end-of-life care to be delivered at home, but they didn’t want to forgo medical care," Dr. Nageswaran recalled. "We went step-by-step, aligning the family’s wishes with the care the child received. We worked with the primary care doctor, the subspecialists, the home health agency, and the parents to provide medical treatment, pain and symptom management, and other care at home."

Both she and Dr. Friedrichsdorf emphasized the value of open inquiry with parents, children and families.

"Each family is unique in how they perceive illness and how they make decisions about treatment and end-of-life care," said Dr. Nageswaran. "When we meet families, we meet them without a set agenda, and we make sure we don’t impose our structure."

Similarly, Dr. Friedrichsdorf said, "When I enter a room, the first thing I say is, ‘How can I help you?’ We start with that open question." At that point, he said, surveys or other structured tools can be used to help determine needs and care plans.

One of the thorns in the field of pediatric palliative care is the unavailability of hospice services for many children, given the prognostic uncertainty of most childhood life-threatening conditions and the desire for continued treatment. Currently, most families have to forgo home-health services in order to receive hospice services.

Some states have taken action; policy reform passed in California in 2006, for instance, makes it easier for parents to utilize the Medi-Cal hospice benefit for children. A section of the federal Patient Protection and Affordable Care Act, moreover, is expected to change the Medicaid system to allow children with life-limiting conditions to receive both hospice care and curative treatment.

Another problem is poor provider reimbursement. "Physician services are reimbursed, but not enough to account for the amount of time involved," said Dr. Nageswaran. "\"And the services of nurses and social workers, who are key to pediatric palliative care programs, are not reimbursed."

She jump-started her program with a grant from the Duke Endowment, a private foundation, but now relies primarily on financial support from the hospital. Dr. Friedrichsdorf estimates that his hospital is reimbursed for only about half of its costs, and says that it relies heavily on philanthropy to make up the difference.

Philanthropy recently benefited the pediatric palliative care program at Akron (Ohio) Children’s Hospital. With $1.2 million in donations from the Haslinger Family Foundation (pdf) and other leadership gifts, the hospital has created an endowed chair for its services, which began in 2002.]

One goal in the meantime, said Dr. Berlinger, is to "influence the culture of health care so that pediatric palliative care is recognized as ethically mandatory."

The $15,000 awards that Dr. Nageswaran and Dr. Friedrichsdorf received were given by the Hastings Center, a bioethics research institute based in Garrison, N.Y., in partnership with the Cunniff-Dixon Foundation, a foundation that focuses on the doctor-patient relationship near the end of life.

Pediatric Palliative Care Training

In terms of education, pediatric palliative care might be where pediatric subspecialties such as pulmonary care or neonatology were 25 years ago, Dr. Friedrichsdorf said, with an initial cadre of trained physicians having emerged.

In 2008, 47 physicians were certified in Hospice and Palliative Medicine (HPM) by the American Board of Pediatrics after taking the first American Board of Medical Specialties–recognized examination for the subspecialty. In total, 1,274 physicians were certified by various boards in the new subspecialty.

The American Board of Medical Specialties (ABMS) approved the creation of HPM as a subspecialty of 10 participating boards in 2006. Prior to 2006, board certification in hospice and palliative medicine was administered by the American Board of Hospice and Palliative Medicine but not recognized by the ABMS.

Other pediatricians have taken courses and attended educational retreats through organizations such as the Initiative for Pediatric Palliative Care, Dr. Berlinger said.

Ideally, she and Dr. Friedrichsdorf say, both educational tracks – fellowships and educational opportunities for mid-career pediatricians – will grow.

Starting in 2013, physicians who want to sit for the HPM board exam will have to have completed an Accreditation Council for Graduate Medical Education-accredited fellowship – a change that should spur the development of more fellowship programs. Children’s Hospitals and Clinics of Minnesota, Dr. Friedrichsdorf’s hospital, houses one of a handful of fellowship programs in pediatric palliative care. It has applied for ACGME approval.

Dr. Friedrichsdorf is the principal investigator of a National Institutes of Health/National Cancer Institute study on the creation and implementation of a pediatric palliative care curriculum that is slated to be offered to physicians who are in the midst of their careers and not seeking subspecialty training.

"Many professionals working in children’s hospitals are likely to care for a dying child, and need to be comfortable and knowledgeable," said Dr. Friedrichsdorf, who completed a fellowship in pediatric pain and palliative care at the Children’s Hospital at Westmead, Australia, after finishing his pediatric residency in Germany.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

A national survey on contraceptive availability suggests that on-site availability of intrauterine devices and other long-acting, reversible contraceptive methods is less than maximal for both office-based physicians and Title X clinics, according to a report in the Jan. 14 Morbidity and Mortality Weekly Report.

Approximately one-quarter of the 635 office-based physicians and nearly one-third of the 1,368 Title X clinic providers who participated in the CDC survey reported that they refer patients to other providers for IUDs – and even higher proportions said they refer patients out for contraceptive implants.

Increasing on-site availability and thus improving access to such long-acting, reversible contraceptive (LARC) methods could reduce rates of unintended pregnancy in the United States, the report stated.

The high unintended pregnancy rate of nearly 50% is thought to result, in part, from less-frequent use of LARC methods, compared with other user-dependent methods such as condoms and oral contraceptives. LARCs have been shown to be more effective in preventing unintended pregnancies during typical use, according to the report (MMWR 2011;60:1-4).

Previous studies have similarly shown that contraceptive availability – through either on-site provision or through prescription or provider recommendation – is highest for oral contraceptives and lower for the patch, IUD, and vaginal ring. This is one of the few studies, however, to examine provider-specific availability of a wide range of contraceptive methods and the first national study to delineate on-site availability without combining hormonal methods into one category, according to the report.

The survey was mailed to physicians in three specialties: obstetrics/gynecology, family medicine, and adolescent medicine. Title X clinics represented a range of provider agencies, including public health departments and community health centers.

Overall, with the exception of the levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) – for which on-site availability was reported by 56% of office-based physicians and 47% of Title X clinic providers – office-based physicians were less likely than were Title X clinics to report on-site availability of a range of contraceptive methods.

While nearly all Title X clinics reported having on-site availability of combined oral contraceptives, for instance, approximately half of office-based physicians had them available on-site and half had them available by prescription. One-quarter of office-based physicians offered progestin-only oral contraceptives on-site, in comparison, and almost 30% offered the contraceptive patch on-site. Most of the others reported that these two methods were available by prescription.

Similarly, male condoms were available on-site in nearly all Title X clinics but only in one-quarter of physicians’ offices.

Survey participants were also asked whether specific contraceptive methods were simply "not available" to their patients. The methods most frequently reported as such were female condoms and implants.

Almost 18% of office-based physicians and 10% of Title X providers said female condoms were unavailable, and 8% and 9% of office-based physicians and Title X providers, respectively, said contraceptive implants were unavailable. On the other hand, almost half of the Title X clinic providers said female condoms were available on-site, compared with 7% of in-office physicians. Contraceptive implants were reported by about one-third of the providers in each category to be available on-site.

The survey findings are limited by a low response rate for office-based physicians (47%), the report noted.

The survey did not ascertain reasons why contraceptive methods were unavailable in some cases or not available on-site. Differences in availability can reflect various factors, from variations in reimbursable costs and health insurance trends, to federal and state policies, provider training and patient characteristics, according to the report.

New federal guidelines on food allergy recommend "prompt and rapid" treatment of food-induced anaphylaxis with intramuscular epinephrine as first-line therapy.

And in cases of a suboptimal response to epinephrine – or if symptoms progress – "repeat epinephrine dosing remains first-line therapy over adjunctive treatments," the guidelines say.

© Julian Rovagnati/Fotolia.com

The "consistency and strength" of the recommendation for prompt treatment with IM epinephrine may come as a surprise to some emergency physicians who "reserve treatment with epinephrine until patients are in shock, which is an extreme and late manifestation" of anaphylaxis, said Dr. Carlos A. Camargo Jr., an emergency physician who served on the multidisciplinary expert panel that developed the guidelines for the National Institute of Allergy and Infectious Diseases.

"Earlier diagnosis of anaphylaxis and earlier treatment with epinephrine would benefit patients," said Dr. Camargo of Massachusetts General Hospital and Harvard Medical School, both in Boston. "The guidelines strongly encourage earlier use of IM epinephrine for food-induced anaphylaxis."

Studies suggest that almost half of food-related allergic reactions in the emergency department involve multiple organ systems and therefore qualify as anaphylaxis, he said in an interview.

The guidelines, published in the December issue of the Journal of Allergy and Clinical Immunology, were based on a systematic literature review combined with consensus expert opinion, and were designed to standardize the diagnosis and management of food allergies across clinical settings and disciplines (J. Allergy Clin. Immunol. 2010;126:1105-18).

Expert opinion played a prominent role in the development of the guidelines – particularly in the section on managing acute allergic reactions to food – because there have been few, if any, controlled studies on food-induced anaphylaxis management, the 25-member expert panel said in the report.

Anaphylaxis, whether food induced or not, is significantly underrecognized and undertreated, they wrote. One possible reason, the panel said, is the "failure to appreciate that anaphylaxis can present without obvious cutaneous symptoms, which happens in 10%-20% of cases, or without overt shock."

Food-induced anaphylaxis can occur within minutes to several hours after a defined exposure to a food allergen. Although it can sometimes take a milder course and resolve spontaneously, it can also be fatal. Deaths from food-induced anaphylaxis have been reported within 30 minutes to 2 hours of exposure, and are associated with delayed use of epinephrine or improper epinephrine dosing, the panel said.

The guidelines, which include guidance and dosing information for epinephrine and various adjunctive treatments – from inhaled bronchodilators and antihistamines to vasopressors and glucagons – caution specifically against the use of H1 and H2 antihistamines for anaphylaxis in anything but an adjunctive role.

Antihistamines such as diphenhydramine are commonly used to treat anaphylaxis, but the report noted that data demonstrating their effectiveness are lacking. Similarly, "there is no persuasive evidence for the use of corticosteroids in acute food-related allergic reactions," Dr. Camargo said.

[Perspective: NIH Guidelines Offer Roadmap for Managing Food Allergies]

Epinephrine has an onset of action within minutes but is rapidly metabolized. Repeated doses of epinephrine may therefore be required after 5-15 minutes, the guidelines say. Among individuals who require epinephrine for anaphylaxis, approximately 10%-20% will require more than one dose, Dr. Camargo emphasized.

The expert panel acknowledged in its report that some level of decision making regarding the risk-benefit ratio of epinephrine "may be warranted" for some patients, but it emphasized that severe adverse effects are rare with epinephrine and are more likely to occur when the drug is given in overdose than in other circumstances.

"Because the risk of death or serious disability from anaphylaxis itself usually outweighs other concerns, existing evidence clearly favors the benefit of epinephrine administration in most situations," the guidelines state.

IM injection of epinephrine should be quickly followed by placement of the patient in a recumbent position (if tolerated, and with lower extremities elevated), the provision of supplemental oxygen, and the administration of intravenous fluid, the panel noted.

Not enough is known, the panel noted, about the true incidence of biphasic and protracted reactions related to food-induced anaphylaxis and how to best prevent or treat these reactions.

Another "knowledge gap" concerns the relative benefits of certain alternative routes of epinephrine administration, such as sublingual administration.

And although little is known about the most effective methods for educating and protecting patients at risk for food-induced anaphylaxis, the guidelines recommend a thorough discharge plan following treatment for food-induced anaphylaxis – one that includes a plan for arranging further evaluation, an anaphylaxis emergency action plan, and an epinephrine auto-injector (two doses) with instructions and a plan for monitoring auto-injector expiration dates.

Management of food-induced anaphylaxis should also include observation for 4-6 hours or longer, based on the severity of the reaction, according to the guidelines.

"Practically speaking, the key is for the patient to be under some type of observation, not necessarily in the emergency department but somewhere with very quick access to emergency care," Dr. Camargo said.

The NIAID-sponsored guidelines were approved by the American College of Emergency Physicians, which had representation on the project’s coordinating committee.

To address potential conflicts of interest, members of the coordinating committee and expert panel submitted voluntary written statements on their relevant and significant financial interests for the NIAID to review. Expert panel members with perceived conflicts of interest were asked to remove themselves from voting on any recommendations relevant to the conflicted topic.

Dr. Camargo reported to the NIAID that he has consulted for and has received funding/grant support from Dey and Novartis, as well as funding/grant support from a variety of government agencies and not-for-profit research foundations.

The complete guidelines, as well as a summary of the expert panel’s report, are available to view or download on the NIAID food allergy guidelines Web site.

New federal guidelines on food allergy recommend "prompt and rapid" treatment of food-induced anaphylaxis with intramuscular epinephrine as first-line therapy.

And in cases of a suboptimal response to epinephrine – or if symptoms progress – "repeat epinephrine dosing remains first-line therapy over adjunctive treatments," the guidelines say.

© Julian Rovagnati/Fotolia.com

The "consistency and strength" of the recommendation for prompt treatment with IM epinephrine may come as a surprise to some emergency physicians who "reserve treatment with epinephrine until patients are in shock, which is an extreme and late manifestation" of anaphylaxis, said Dr. Carlos A. Camargo Jr., an emergency physician who served on the multidisciplinary expert panel that developed the guidelines for the National Institute of Allergy and Infectious Diseases.

"Earlier diagnosis of anaphylaxis and earlier treatment with epinephrine would benefit patients," said Dr. Camargo of Massachusetts General Hospital and Harvard Medical School, both in Boston. "The guidelines strongly encourage earlier use of IM epinephrine for food-induced anaphylaxis."

Studies suggest that almost half of food-related allergic reactions in the emergency department involve multiple organ systems and therefore qualify as anaphylaxis, he said in an interview.

The guidelines, published in the December issue of the Journal of Allergy and Clinical Immunology, were based on a systematic literature review combined with consensus expert opinion, and were designed to standardize the diagnosis and management of food allergies across clinical settings and disciplines (J. Allergy Clin. Immunol. 2010;126:1105-18).

Expert opinion played a prominent role in the development of the guidelines – particularly in the section on managing acute allergic reactions to food – because there have been few, if any, controlled studies on food-induced anaphylaxis management, the 25-member expert panel said in the report.

Anaphylaxis, whether food induced or not, is significantly underrecognized and undertreated, they wrote. One possible reason, the panel said, is the "failure to appreciate that anaphylaxis can present without obvious cutaneous symptoms, which happens in 10%-20% of cases, or without overt shock."

Food-induced anaphylaxis can occur within minutes to several hours after a defined exposure to a food allergen. Although it can sometimes take a milder course and resolve spontaneously, it can also be fatal. Deaths from food-induced anaphylaxis have been reported within 30 minutes to 2 hours of exposure, and are associated with delayed use of epinephrine or improper epinephrine dosing, the panel said.

The guidelines, which include guidance and dosing information for epinephrine and various adjunctive treatments – from inhaled bronchodilators and antihistamines to vasopressors and glucagons – caution specifically against the use of H1 and H2 antihistamines for anaphylaxis in anything but an adjunctive role.

Antihistamines such as diphenhydramine are commonly used to treat anaphylaxis, but the report noted that data demonstrating their effectiveness are lacking. Similarly, "there is no persuasive evidence for the use of corticosteroids in acute food-related allergic reactions," Dr. Camargo said.

[Perspective: NIH Guidelines Offer Roadmap for Managing Food Allergies]

Epinephrine has an onset of action within minutes but is rapidly metabolized. Repeated doses of epinephrine may therefore be required after 5-15 minutes, the guidelines say. Among individuals who require epinephrine for anaphylaxis, approximately 10%-20% will require more than one dose, Dr. Camargo emphasized.

The expert panel acknowledged in its report that some level of decision making regarding the risk-benefit ratio of epinephrine "may be warranted" for some patients, but it emphasized that severe adverse effects are rare with epinephrine and are more likely to occur when the drug is given in overdose than in other circumstances.

"Because the risk of death or serious disability from anaphylaxis itself usually outweighs other concerns, existing evidence clearly favors the benefit of epinephrine administration in most situations," the guidelines state.

IM injection of epinephrine should be quickly followed by placement of the patient in a recumbent position (if tolerated, and with lower extremities elevated), the provision of supplemental oxygen, and the administration of intravenous fluid, the panel noted.

Not enough is known, the panel noted, about the true incidence of biphasic and protracted reactions related to food-induced anaphylaxis and how to best prevent or treat these reactions.

Another "knowledge gap" concerns the relative benefits of certain alternative routes of epinephrine administration, such as sublingual administration.

And although little is known about the most effective methods for educating and protecting patients at risk for food-induced anaphylaxis, the guidelines recommend a thorough discharge plan following treatment for food-induced anaphylaxis – one that includes a plan for arranging further evaluation, an anaphylaxis emergency action plan, and an epinephrine auto-injector (two doses) with instructions and a plan for monitoring auto-injector expiration dates.

Management of food-induced anaphylaxis should also include observation for 4-6 hours or longer, based on the severity of the reaction, according to the guidelines.

"Practically speaking, the key is for the patient to be under some type of observation, not necessarily in the emergency department but somewhere with very quick access to emergency care," Dr. Camargo said.

The NIAID-sponsored guidelines were approved by the American College of Emergency Physicians, which had representation on the project’s coordinating committee.

To address potential conflicts of interest, members of the coordinating committee and expert panel submitted voluntary written statements on their relevant and significant financial interests for the NIAID to review. Expert panel members with perceived conflicts of interest were asked to remove themselves from voting on any recommendations relevant to the conflicted topic.

Dr. Camargo reported to the NIAID that he has consulted for and has received funding/grant support from Dey and Novartis, as well as funding/grant support from a variety of government agencies and not-for-profit research foundations.

The complete guidelines, as well as a summary of the expert panel’s report, are available to view or download on the NIAID food allergy guidelines Web site.

New federal guidelines on food allergy recommend "prompt and rapid" treatment of food-induced anaphylaxis with intramuscular epinephrine as first-line therapy.

And in cases of a suboptimal response to epinephrine – or if symptoms progress – "repeat epinephrine dosing remains first-line therapy over adjunctive treatments," the guidelines say.

© Julian Rovagnati/Fotolia.com

The "consistency and strength" of the recommendation for prompt treatment with IM epinephrine may come as a surprise to some emergency physicians who "reserve treatment with epinephrine until patients are in shock, which is an extreme and late manifestation" of anaphylaxis, said Dr. Carlos A. Camargo Jr., an emergency physician who served on the multidisciplinary expert panel that developed the guidelines for the National Institute of Allergy and Infectious Diseases.

"Earlier diagnosis of anaphylaxis and earlier treatment with epinephrine would benefit patients," said Dr. Camargo of Massachusetts General Hospital and Harvard Medical School, both in Boston. "The guidelines strongly encourage earlier use of IM epinephrine for food-induced anaphylaxis."

Studies suggest that almost half of food-related allergic reactions in the emergency department involve multiple organ systems and therefore qualify as anaphylaxis, he said in an interview.

The guidelines, published in the December issue of the Journal of Allergy and Clinical Immunology, were based on a systematic literature review combined with consensus expert opinion, and were designed to standardize the diagnosis and management of food allergies across clinical settings and disciplines (J. Allergy Clin. Immunol. 2010;126:1105-18).

Expert opinion played a prominent role in the development of the guidelines – particularly in the section on managing acute allergic reactions to food – because there have been few, if any, controlled studies on food-induced anaphylaxis management, the 25-member expert panel said in the report.

Anaphylaxis, whether food induced or not, is significantly underrecognized and undertreated, they wrote. One possible reason, the panel said, is the "failure to appreciate that anaphylaxis can present without obvious cutaneous symptoms, which happens in 10%-20% of cases, or without overt shock."

Food-induced anaphylaxis can occur within minutes to several hours after a defined exposure to a food allergen. Although it can sometimes take a milder course and resolve spontaneously, it can also be fatal. Deaths from food-induced anaphylaxis have been reported within 30 minutes to 2 hours of exposure, and are associated with delayed use of epinephrine or improper epinephrine dosing, the panel said.

The guidelines, which include guidance and dosing information for epinephrine and various adjunctive treatments – from inhaled bronchodilators and antihistamines to vasopressors and glucagons – caution specifically against the use of H1 and H2 antihistamines for anaphylaxis in anything but an adjunctive role.

Antihistamines such as diphenhydramine are commonly used to treat anaphylaxis, but the report noted that data demonstrating their effectiveness are lacking. Similarly, "there is no persuasive evidence for the use of corticosteroids in acute food-related allergic reactions," Dr. Camargo said.

[Perspective: NIH Guidelines Offer Roadmap for Managing Food Allergies]

Epinephrine has an onset of action within minutes but is rapidly metabolized. Repeated doses of epinephrine may therefore be required after 5-15 minutes, the guidelines say. Among individuals who require epinephrine for anaphylaxis, approximately 10%-20% will require more than one dose, Dr. Camargo emphasized.

The expert panel acknowledged in its report that some level of decision making regarding the risk-benefit ratio of epinephrine "may be warranted" for some patients, but it emphasized that severe adverse effects are rare with epinephrine and are more likely to occur when the drug is given in overdose than in other circumstances.

"Because the risk of death or serious disability from anaphylaxis itself usually outweighs other concerns, existing evidence clearly favors the benefit of epinephrine administration in most situations," the guidelines state.

IM injection of epinephrine should be quickly followed by placement of the patient in a recumbent position (if tolerated, and with lower extremities elevated), the provision of supplemental oxygen, and the administration of intravenous fluid, the panel noted.

Not enough is known, the panel noted, about the true incidence of biphasic and protracted reactions related to food-induced anaphylaxis and how to best prevent or treat these reactions.

Another "knowledge gap" concerns the relative benefits of certain alternative routes of epinephrine administration, such as sublingual administration.

And although little is known about the most effective methods for educating and protecting patients at risk for food-induced anaphylaxis, the guidelines recommend a thorough discharge plan following treatment for food-induced anaphylaxis – one that includes a plan for arranging further evaluation, an anaphylaxis emergency action plan, and an epinephrine auto-injector (two doses) with instructions and a plan for monitoring auto-injector expiration dates.

Management of food-induced anaphylaxis should also include observation for 4-6 hours or longer, based on the severity of the reaction, according to the guidelines.

"Practically speaking, the key is for the patient to be under some type of observation, not necessarily in the emergency department but somewhere with very quick access to emergency care," Dr. Camargo said.

The NIAID-sponsored guidelines were approved by the American College of Emergency Physicians, which had representation on the project’s coordinating committee.

To address potential conflicts of interest, members of the coordinating committee and expert panel submitted voluntary written statements on their relevant and significant financial interests for the NIAID to review. Expert panel members with perceived conflicts of interest were asked to remove themselves from voting on any recommendations relevant to the conflicted topic.

Dr. Camargo reported to the NIAID that he has consulted for and has received funding/grant support from Dey and Novartis, as well as funding/grant support from a variety of government agencies and not-for-profit research foundations.

The complete guidelines, as well as a summary of the expert panel’s report, are available to view or download on the NIAID food allergy guidelines Web site.

Discussing the risks of the human papillomavirus and vaccinating teenage and young adult patients is no easy feat, but many gynecologic practices will find they can do it – and be “in the black” financially” – if they just appoint an office “vaccine advocate” to take charge of instituting national vaccination recommendations.

So says Dr. Stanley A. Gall, professor of obstetrics and gynecology at the University of Louisville (Ky.) and the American College of Obstetricians and Gynecologists' liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, he and other experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil (the first of two HPV vaccines) was licensed.

Pediatricians are vaccine experts and are used to low fees for vaccine administration, but in the case of HPV vaccine, they're challenged by their key age group: the 11- to 12-year-olds for whom the vaccine is recommended as part of the regular immunization schedule.

A recent survey of more than 1,500 parents showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010;125:654-9).

Ob.gyns., on the other hand, are better positioned to discuss HPV infection as a sexually transmitted disease, but for many, vaccination requires a true “paradigm shift” in terms of practice values and resources.

HPV vaccination is recommended by ACIP on a “catch-up” basis for young women aged 13–26 years. Most private insurers cover vaccination, sources said, although coverage through some insurers diminishes in the 19- to 26-year age bracket. The public sector, Dr. Gall said, is now “catching up” with the private sector in covering HPV vaccination.

“Practices need to look at the reimbursement they're getting [or would get] from a handful of their insurers, and find out if they're in the black or the red,” said Dr. Gall, a member of ACIP's working group on HPV. “A lot of times, offices find that even though the amounts are small, they can make money.”

Success with HPV vaccine administration – as well as the administration of other vaccines – often comes with the appointment of a nurse or other practice member who “feels passionate” about the value of vaccination and can take charge of ordering and properly storing vaccines as well as teaching staff about proper vaccination indications, schedules, and techniques, said Dr. Gall.

“The physician shouldn't even have to think about it,” he said, noting that practices must institute standing orders for vaccines to be delivered in the physician's absence. “Take it out of their hands and make it a routine in the office.”

Even though the ob.gyn. practice staff may be more likely than pediatricians to find patients and parents more appreciative of HPV risks, it is still important to understand and anticipate the common reasons for refusal of the vaccine, Dr. Gall and other experts told this news organization.

For one, “there isn't as immediate a preventive effect” to appreciate compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both [teens] and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “Why Now” Factor. HPV infection is the most commonly occurring STD. About 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

It is important to emphasize, however, that vaccination is not about sexual readiness or sexual activity but about preventing cervical cancer – and, sources said, it's important to give numbers.

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, explains that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%–90% HPV vaccination rate in female patients.

Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute, advises telling patients and parents that “studies show without a doubt that when you vaccinate at a younger age, you get much higher immunity levels.”

And Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco, advises telling patients that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe by parents.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents who are concerned about safety to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the Web site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of Efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can [say] that, as with any new vaccine, we [don't know] how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7 and a half years, and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine Differences. The most important facts for parents and/or older patients to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, said Dr. Gall.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV−16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Block has done research for both manufacturers and is on the speakers bureau for Gardasil (Merck's HPV vaccine). Dr. Pichichero has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively. Dr. Gall said he was working on clinical trials and is a speaker for GSK and Merck. The other physicians reported no disclosures.

Tell patients studies show 'that when you vaccinate at a younger age, you get much higher immunity levels.'

Source DR. PICHICHERO

Tell patients that at least 10,000 women die each year of cervical cancer, and HPV causes cervical cancer.

Source ©BVDC/Fotolia.com

Emphasize vaccination is not about sexual activity, but about preventing cervical cancer.

Source DR. BOCCHINI

Discussing the risks of the human papillomavirus and vaccinating teenage and young adult patients is no easy feat, but many gynecologic practices will find they can do it – and be “in the black” financially” – if they just appoint an office “vaccine advocate” to take charge of instituting national vaccination recommendations.

So says Dr. Stanley A. Gall, professor of obstetrics and gynecology at the University of Louisville (Ky.) and the American College of Obstetricians and Gynecologists' liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, he and other experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil (the first of two HPV vaccines) was licensed.

Pediatricians are vaccine experts and are used to low fees for vaccine administration, but in the case of HPV vaccine, they're challenged by their key age group: the 11- to 12-year-olds for whom the vaccine is recommended as part of the regular immunization schedule.

A recent survey of more than 1,500 parents showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010;125:654-9).

Ob.gyns., on the other hand, are better positioned to discuss HPV infection as a sexually transmitted disease, but for many, vaccination requires a true “paradigm shift” in terms of practice values and resources.

HPV vaccination is recommended by ACIP on a “catch-up” basis for young women aged 13–26 years. Most private insurers cover vaccination, sources said, although coverage through some insurers diminishes in the 19- to 26-year age bracket. The public sector, Dr. Gall said, is now “catching up” with the private sector in covering HPV vaccination.

“Practices need to look at the reimbursement they're getting [or would get] from a handful of their insurers, and find out if they're in the black or the red,” said Dr. Gall, a member of ACIP's working group on HPV. “A lot of times, offices find that even though the amounts are small, they can make money.”

Success with HPV vaccine administration – as well as the administration of other vaccines – often comes with the appointment of a nurse or other practice member who “feels passionate” about the value of vaccination and can take charge of ordering and properly storing vaccines as well as teaching staff about proper vaccination indications, schedules, and techniques, said Dr. Gall.

“The physician shouldn't even have to think about it,” he said, noting that practices must institute standing orders for vaccines to be delivered in the physician's absence. “Take it out of their hands and make it a routine in the office.”

Even though the ob.gyn. practice staff may be more likely than pediatricians to find patients and parents more appreciative of HPV risks, it is still important to understand and anticipate the common reasons for refusal of the vaccine, Dr. Gall and other experts told this news organization.

For one, “there isn't as immediate a preventive effect” to appreciate compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both [teens] and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “Why Now” Factor. HPV infection is the most commonly occurring STD. About 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

It is important to emphasize, however, that vaccination is not about sexual readiness or sexual activity but about preventing cervical cancer – and, sources said, it's important to give numbers.

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, explains that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%–90% HPV vaccination rate in female patients.

Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute, advises telling patients and parents that “studies show without a doubt that when you vaccinate at a younger age, you get much higher immunity levels.”

And Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco, advises telling patients that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe by parents.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents who are concerned about safety to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the Web site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of Efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can [say] that, as with any new vaccine, we [don't know] how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7 and a half years, and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine Differences. The most important facts for parents and/or older patients to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, said Dr. Gall.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV−16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Block has done research for both manufacturers and is on the speakers bureau for Gardasil (Merck's HPV vaccine). Dr. Pichichero has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively. Dr. Gall said he was working on clinical trials and is a speaker for GSK and Merck. The other physicians reported no disclosures.

Tell patients studies show 'that when you vaccinate at a younger age, you get much higher immunity levels.'

Source DR. PICHICHERO

Tell patients that at least 10,000 women die each year of cervical cancer, and HPV causes cervical cancer.

Source ©BVDC/Fotolia.com

Emphasize vaccination is not about sexual activity, but about preventing cervical cancer.

Source DR. BOCCHINI

Discussing the risks of the human papillomavirus and vaccinating teenage and young adult patients is no easy feat, but many gynecologic practices will find they can do it – and be “in the black” financially” – if they just appoint an office “vaccine advocate” to take charge of instituting national vaccination recommendations.

So says Dr. Stanley A. Gall, professor of obstetrics and gynecology at the University of Louisville (Ky.) and the American College of Obstetricians and Gynecologists' liaison to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, he and other experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil (the first of two HPV vaccines) was licensed.

Pediatricians are vaccine experts and are used to low fees for vaccine administration, but in the case of HPV vaccine, they're challenged by their key age group: the 11- to 12-year-olds for whom the vaccine is recommended as part of the regular immunization schedule.

A recent survey of more than 1,500 parents showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010;125:654-9).

Ob.gyns., on the other hand, are better positioned to discuss HPV infection as a sexually transmitted disease, but for many, vaccination requires a true “paradigm shift” in terms of practice values and resources.

HPV vaccination is recommended by ACIP on a “catch-up” basis for young women aged 13–26 years. Most private insurers cover vaccination, sources said, although coverage through some insurers diminishes in the 19- to 26-year age bracket. The public sector, Dr. Gall said, is now “catching up” with the private sector in covering HPV vaccination.

“Practices need to look at the reimbursement they're getting [or would get] from a handful of their insurers, and find out if they're in the black or the red,” said Dr. Gall, a member of ACIP's working group on HPV. “A lot of times, offices find that even though the amounts are small, they can make money.”

Success with HPV vaccine administration – as well as the administration of other vaccines – often comes with the appointment of a nurse or other practice member who “feels passionate” about the value of vaccination and can take charge of ordering and properly storing vaccines as well as teaching staff about proper vaccination indications, schedules, and techniques, said Dr. Gall.

“The physician shouldn't even have to think about it,” he said, noting that practices must institute standing orders for vaccines to be delivered in the physician's absence. “Take it out of their hands and make it a routine in the office.”

Even though the ob.gyn. practice staff may be more likely than pediatricians to find patients and parents more appreciative of HPV risks, it is still important to understand and anticipate the common reasons for refusal of the vaccine, Dr. Gall and other experts told this news organization.

For one, “there isn't as immediate a preventive effect” to appreciate compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both [teens] and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “Why Now” Factor. HPV infection is the most commonly occurring STD. About 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

It is important to emphasize, however, that vaccination is not about sexual readiness or sexual activity but about preventing cervical cancer – and, sources said, it's important to give numbers.

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, explains that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%–90% HPV vaccination rate in female patients.

Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute, advises telling patients and parents that “studies show without a doubt that when you vaccinate at a younger age, you get much higher immunity levels.”

And Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco, advises telling patients that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe by parents.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents who are concerned about safety to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the Web site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of Efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can [say] that, as with any new vaccine, we [don't know] how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7 and a half years, and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine Differences. The most important facts for parents and/or older patients to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, said Dr. Gall.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV−16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Block has done research for both manufacturers and is on the speakers bureau for Gardasil (Merck's HPV vaccine). Dr. Pichichero has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively. Dr. Gall said he was working on clinical trials and is a speaker for GSK and Merck. The other physicians reported no disclosures.

Tell patients studies show 'that when you vaccinate at a younger age, you get much higher immunity levels.'

Source DR. PICHICHERO

Tell patients that at least 10,000 women die each year of cervical cancer, and HPV causes cervical cancer.

Source ©BVDC/Fotolia.com

Emphasize vaccination is not about sexual activity, but about preventing cervical cancer.

Source DR. BOCCHINI

Major Finding: Treatment with atopaxar, a PAR-1 thrombin receptor antagonist, resulted in a rate of bleeding of 3.1% in patients with acute coronary syndromes, compared with 2.2% among patients who received placebo, a statistically nonsignificant difference.

Data Source: LANCELOT ACS, a prospective, randomized, double-blinded, placebo-controlled study of 603 patients with acute coronary syndromes.

Disclosures: The study was funded by Eisai Inc. Dr. O'Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly and Daiichi Sankyo.

WASHINGTON — Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial's lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y₁₂ inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O'Donoghue of Brigham and Women's Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition … without a significant increase in bleeding in patients with ACS,” Dr. O'Donoghue reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O'Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O'Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

Major Finding: Treatment with atopaxar, a PAR-1 thrombin receptor antagonist, resulted in a rate of bleeding of 3.1% in patients with acute coronary syndromes, compared with 2.2% among patients who received placebo, a statistically nonsignificant difference.

Data Source: LANCELOT ACS, a prospective, randomized, double-blinded, placebo-controlled study of 603 patients with acute coronary syndromes.

Disclosures: The study was funded by Eisai Inc. Dr. O'Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly and Daiichi Sankyo.

WASHINGTON — Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial's lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y₁₂ inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O'Donoghue of Brigham and Women's Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition … without a significant increase in bleeding in patients with ACS,” Dr. O'Donoghue reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O'Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O'Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

Major Finding: Treatment with atopaxar, a PAR-1 thrombin receptor antagonist, resulted in a rate of bleeding of 3.1% in patients with acute coronary syndromes, compared with 2.2% among patients who received placebo, a statistically nonsignificant difference.

Data Source: LANCELOT ACS, a prospective, randomized, double-blinded, placebo-controlled study of 603 patients with acute coronary syndromes.

Disclosures: The study was funded by Eisai Inc. Dr. O'Donoghue disclosed that she has received research support from Eisai and GlaxoSmithKline, and that she is a consultant for Eli Lilly and Daiichi Sankyo.

WASHINGTON — Treatment with the investigational antiplatelet agent atopaxar did not significantly increase bleeding in patients with acute coronary syndromes in a randomized trial, making protease-activated receptor-1 blockade “a promising target” for ACS treatment, the trial's lead investigator reported.

Drugs that inhibit platelet activation, such as aspirin and P2Y₁₂ inhibitors (clopidogrel, for instance), are the mainstay of therapy for patients with ACS, but these drugs do not inhibit the thrombin receptor as atopaxar does. “Thrombin is known to be the most potent platelet agonist,” explained Dr. Michelle O'Donoghue of Brigham and Women's Hospital in Boston.

Thrombin acts primarily via the PAR-1 receptor, which has led investigators to wonder whether PAR-1 receptor blockage – in addition to the current antiplatelet therapy – can move clinicians closer to the goal of reducing major adverse cardiac events without increasing the incidence of clinically significant bleeding.

Results from the LANCELOT ACS trial show that the PAR-1 antagonist atopaxar “achieves potent and rapid platelet inhibition … without a significant increase in bleeding in patients with ACS,” Dr. O'Donoghue reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

In the multicenter, double-blind study, 603 patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) were randomized within 72 hours of symptom onset to receive either placebo or a 400-mg loading dose of atopaxar followed by a daily maintenance dose of 50 mg, 100 mg, or 200 mg for 12 weeks. The patients were followed for 4 weeks and, with few exceptions, were treated with aspirin or dual antiplatelet therapy in addition to atopaxar or the placebo drug.

The average rate of bleeding across the three atopaxar groups was 3.1% according to the CURE bleeding classification (1.8% CURE major and 1.3% CURE minor), compared with 2.2% in placebo group (all CURE minor). There was “no evidence of any dose-dependent trend,” Dr. O'Donoghue said.

The study, funded by Eisai Inc., was not powered for efficacy – the primary objective was to establish safety and tolerability – but “numerically, there was a lower incidence of cardiovascular death, MI, or stroke in the active combined group as compared with placebo,” Dr. O'Donoghue said. This difference was not statistically significant, but it shows “favorable trends for efficacy,” she said.

The incidence of Holter-detected ischemia at 48 hours following a 400-mg loading dose also was significantly lower in the atopaxar groups, compared with placebo.

“There was a significant 33% relative risk reduction [in the atopaxar groups combined],” she said. “This is the first time an oral antiplatelet drug was shown to reduce Holter-detected ischemia.”

Overall, the drug was well tolerated, but dose-dependent transaminitis and relative QTc prolongation were observed with the higher doses of atopaxar.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still “a million dollar question,” said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

“If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet” from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

“If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message,” said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

“Parents have never heard this type of approach used with a vaccine before,” he said.

It is important to tailor one's approach to the fact that “there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both children and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “why now” factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

“But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response … and at an age that is prior to the risk,” said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

“Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgment that their daughter is about to become sexually active, whether or not that's true,” said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, “studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels.”

Kaiser's Dr. Wibbelsman said he tells parents that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that “numbers give parents something concrete to hang their hats on.” He tells many parents that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. “You have to test the waters, the comfort level of the child … but whenever possible, I lay all this out.”

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. “Without a doubt, it's a malpractice risk,” he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their “National Advisory Boards for periodic 1-day consulting.” Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still “a million dollar question,” said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

“If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet” from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

“If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message,” said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

“Parents have never heard this type of approach used with a vaccine before,” he said.

It is important to tailor one's approach to the fact that “there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both children and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “why now” factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

“But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response … and at an age that is prior to the risk,” said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

“Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgment that their daughter is about to become sexually active, whether or not that's true,” said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, “studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels.”

Kaiser's Dr. Wibbelsman said he tells parents that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that “numbers give parents something concrete to hang their hats on.” He tells many parents that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. “You have to test the waters, the comfort level of the child … but whenever possible, I lay all this out.”

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. “Without a doubt, it's a malpractice risk,” he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their “National Advisory Boards for periodic 1-day consulting.” Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still “a million dollar question,” said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did “not believe the vaccine is effective in preventing the disease” (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

“If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet” from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

“If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message,” said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

“Parents have never heard this type of approach used with a vaccine before,” he said.

It is important to tailor one's approach to the fact that “there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines,” said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

“We can do better at being straightforward in addressing the issues of HPV, with both children and their parents,” he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

▸ The “why now” factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

“But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response … and at an age that is prior to the risk,” said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

“Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgment that their daughter is about to become sexually active, whether or not that's true,” said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, “studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels.”

Kaiser's Dr. Wibbelsman said he tells parents that at least “10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer.”

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that “numbers give parents something concrete to hang their hats on.” He tells many parents that “the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination,” and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

“We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children,” said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. “You have to test the waters, the comfort level of the child … but whenever possible, I lay all this out.”

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. “Without a doubt, it's a malpractice risk,” he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

▸ Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

“I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine,” said Dr. Freed. “Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer.”

Others said they refer parents to the CDC's Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding “no pattern or clustering … to suggest they were caused by the HPV vaccination,” the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

▸ Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8–10 years at this point, with no “breakthrough cases” of HPV infection, sources said.

“We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer,” said Dr. Bocchini. If needed in the future, a booster dose will become available.

▸ Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and −11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. “There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer,” not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and −18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their “National Advisory Boards for periodic 1-day consulting.” Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics’ committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying ‘It’s time to receive your HPV vaccine,’ there’s often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying ‘It’s time to discuss the possibility of your daughter receiving the HPV vaccine,’ immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one’s approach to the fact that "there isn’t as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, ‘I want to have this discussion 2 years from now,’ I think it’s our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics’ committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren’t ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that’s true," said Dr. Pichichero.

That’s why it’s important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser’s Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child’s chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it’s a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents’ changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC’s Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv). "This way, it’s not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP’s HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can’t say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we’re seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics’ committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying ‘It’s time to receive your HPV vaccine,’ there’s often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying ‘It’s time to discuss the possibility of your daughter receiving the HPV vaccine,’ immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one’s approach to the fact that "there isn’t as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, ‘I want to have this discussion 2 years from now,’ I think it’s our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics’ committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren’t ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that’s true," said Dr. Pichichero.

That’s why it’s important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser’s Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child’s chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it’s a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents’ changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC’s Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv). "This way, it’s not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP’s HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can’t say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we’re seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, a pediatrician who is chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics’ committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying ‘It’s time to receive your HPV vaccine,’ there’s often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying ‘It’s time to discuss the possibility of your daughter receiving the HPV vaccine,’ immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one’s approach to the fact that "there isn’t as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, pediatricians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, ‘I want to have this discussion 2 years from now,’ I think it’s our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics’ committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and pediatricians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren’t ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that’s true," said Dr. Pichichero.

That’s why it’s important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser’s Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in a six-pediatrician group in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child’s chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it’s a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents’ changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC’s Web site for vaccine safety profiles (www.cdc.gov/vaccinesafety/vaccines/hpv). "This way, it’s not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP’s HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can’t say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we’re seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several pediatricians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one's approach to the fact that "there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, clinicians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and clinicians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that's true," said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser's Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it's a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC's Web site for vaccine safety profiles. "This way, it's not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP's HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one's approach to the fact that "there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, clinicians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and clinicians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that's true," said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser's Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it's a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC's Web site for vaccine safety profiles. "This way, it's not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP's HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.

Discussing the risks of the human papillomavirus and the value of HPV vaccination is no easy feat for physicians who are seeing preteen and teenage girls and trying to institute national vaccination recommendations.

Especially in the 11- to 12-year-old population – the age group for whom the vaccine is recommended as part of the regular immunization schedule – how to best address HPV risk is still "a million dollar question," said Dr. Charles Wibbelsman, chief of adolescent medicine at Kaiser Permanente in San Francisco and a former member of the American Academy of Pediatrics' committee on adolescents.

Uptake of the vaccine has been slower and lower than it has been for other vaccines, experts say, and both surveys and interviews with physicians around the country indicate that physicians face a host of moral, ethical, and safety concerns from parents, even though almost 5 years have passed since Gardasil – the first of two HPV vaccines – was licensed.

A survey of more than 1,500 parents published last April, for instance, showed that the HPV vaccine was the most commonly refused pediatric vaccine. Almost 80% of the parents who refused said they believed there had not been enough research on it, 51% said it challenged their belief systems, 59% said they believed their children were at low risk for contracting the sexually transmitted disease, and 37% said they did "not believe the vaccine is effective in preventing the disease" (Pediatrics 2010:125:654-9).

Physicians who spoke with this news organization said that understanding and anticipating these common reasons for refusal of the vaccine are key to an efficient and meaningful discussion of HPV risks. So is the use of affirmative, matter-of-fact statements about HPV vaccination.

"If you approach it by saying 'It's time to receive your HPV vaccine,' there's often no need to go any further, other than providing parents with the appropriate information pamphlet" from the Centers for Disease Control and Prevention, said Dr. Michael E. Pichichero, director of the Rochester (N.Y.) General Hospital Research Institute and a pediatrician in private practice in that city.

"If you start out, on the other hand, by saying 'It's time to discuss the possibility of your daughter receiving the HPV vaccine,' immediately that sends a very different message," said Dr. Pichichero, who has served as a consultant for both Merck and GlaxoSmithKline, the manufacturers of Gardasil and Cervarix, respectively.

"Parents have never heard this type of approach used with a vaccine before," he said.

It is important to tailor one's approach to the fact that "there isn't as immediate a preventive effect that parents can appreciate, compared with other vaccines," said Dr. Gary L. Freed, immediate past chairman of the National Vaccine Advisory Committee and director of the division of general pediatrics and the child health evaluation and research unit at the University of Michigan in Ann Arbor.

"We can do better at being straightforward in addressing the issues of HPV, with both children and their parents," he said.

The following are some of the suggestions offered and experiences shared by these physicians and others:

• The "Why Now" Factor. As with other sensitive issues, clinicians have to tailor the depth of discussion about HPV infection to the maturity of the child and values of the family.

"But when a parent [of an 11- to 12-year-old] says, 'I want to have this discussion 2 years from now,' I think it's our responsibility to share data about the risk, and to convey the fact that we want to provide universal protection at an age when we know the child will respond effectively to the vaccine by developing a strong immune response ... and at an age that is prior to the risk," said Dr. Joseph Bocchini, immediate past chairman of the American Academy of Pediatrics' committee on infectious diseases and chairman of the department of pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Both parents and clinicians underestimate the likelihood that their child or patient is sexually active or about to become sexually active, said Dr. Bocchini, who also serves on the HPV working group of the CDC's Advisory Committee on Immunization Practices (ACIP).

In all, 20% of adolescents are infected with HPV within 2 years of the onset of sexual activity, he said, which for the majority of girls occurs during their teenage years.

Although physicians should not shy away from discussing HPV infection as a sexually transmitted disease – indeed, it is the most commonly occurring STD – they should nevertheless take care to emphasize the overall goal of vaccination: the prevention of cervical cancer.

"Most mothers aren't ready to deal with the possibility of their daughter becoming sexually active, so they tie together the vaccine with more or less an acknowledgement that their daughter is about to become sexually active, whether or not that's true," said Dr. Pichichero.

That's why it's important, he and others said, to emphasize that vaccination is not about sexual readiness, but about preventing cervical cancer. Providing the vaccine has not been shown in any way to increase sexual activity, he and other physicians said. And, Dr. Pichichero added, "studies show, without a doubt, that when you vaccinate at a younger age, you get much higher immunity levels."

Kaiser's Dr. Wibbelsman said he tells parents that at least "10,000 women die each year of cervical cancer and countless others have cervical cancer, and that HPV causes cervical cancer."

Dr. Stan Block, who practices in Bardstown, Ky., with a large adolescent population, said that "numbers give parents something concrete to hang their hats on." He tells many parents that "the lifetime risk of getting cervical, anal, vaginal, or vulvar precancer or cancer goes from about 1 in 20 without vaccination to 1 in 50 with vaccination," and that the risk of venereal warts similarly drops from 1 in 10 without vaccination with Gardasil to about 1 in 100 with vaccination.

"We explain that even precancerous lesions can have serious consequences, like surgery and the inability to have children," said Dr. Block, who estimates that his practice has an 85%-90% HPV vaccination rate in female patients. "You have to test the waters, the comfort level of the child ... but whenever possible, I lay all this out."

When parents refuse the vaccine, he either tells them that he is documenting the refusal in their child's chart or asks them to sign a form to document that they acknowledge the risk of refusing vaccination. "Without a doubt, it's a malpractice risk," he said. Sometimes, he added, such a statement or request results in parents' changing their minds.

• Safety. At least several studies have shown that the vaccine would receive greater acceptance if it was perceived to be safe.

"I tell parents that the vaccine has now been received by literally hundreds of thousands in this country, and that there are no serious adverse events associated with the vaccine," said Dr. Freed. "Then I say that in the same time period, there likely have been at least several thousand young women who have been infected with HPV who will develop precancerous cervical lesions and may go on to develop cervical cancer."

Others said they refer parents to the CDC's Web site for vaccine safety profiles. "This way, it's not me talking, and not the manufacturer, but a body with a lot of credibility," said Dr. Stanley Gall, professor of ob.gyn at the University of Louisville (Ky.) and a member of ACIP's HPV working group.

According to the CDC Web site, approximately 32 million doses of Gardasil were distributed in the United States from the time the vaccine was licensed in 2006 until September 2010. All serious adverse event reports that were made to the Vaccine Adverse Event Reporting System have been fully investigated, with staff finding "no pattern or clustering ... to suggest they were caused by the HPV vaccination," the site says.

Syncope and fainting are common in preteens and teens after injections, the CDC notes, making the recommended 15-minute postvaccination observation period extremely important. Patients should lie down or sit for this period of time.

• Duration of efficacy. Manufacturers have tracked vaccine recipients for up to 8-10 years at this point, with no "breakthrough cases" of HPV infection, sources said.

"We can tell parents that – as with any new vaccine – we can't say how long efficacy will last, but that we do know the vaccine is highly immunogenic, that we're seeing no breakthrough cases in the recipients being followed, and that we know protection will last at least 7.5 years and likely significantly longer," said Dr. Bocchini. If needed in the future, a booster dose will become available.

• Vaccine differences. The most important facts for parents to know, several physicians said, is that both Gardasil and Cervarix protect against the two strains of HPV (types 16 and 18) that are believed to cause 70% of all cervical cancers, and that Gardasil also protects against HPV-6 and -11, the most common cause of genital warts.

Parents and older teens should know the value of protecting against genital warts, they said. "There are about a million new cases of genital warts each year in this country, and the amount of money spent treating them is equivalent to the amount of money spent treating cervical cancer," not to mention the fact that genital warts cause significant anguish, Dr. Gall said.

Dr. Pichichero, however, said that Cervarix contains a novel adjuvant that is believed to be responsible for its ability to generate a greater antibody response to HPV-16 and -18, compared with Gardasil. Higher antibody titers may translate into a longer duration of protection, he said.

Cervarix also has been shown, he said, to afford some level of cross-protection against other HPV strains that are responsible for a small yet significant proportion of cervical cancer cases. Although such differences should be weighed in the long term, right now it seems that parents are more concerned about safety and experience with the vaccines, and physicians should focus on this, he said.

Dr. Pichichero said he has served as a consultant to Merck and GlaxoSmithKline on their "National Advisory Boards for periodic 1-day consulting." Dr. Block said he has done research for both companies and is on the speakers bureau for Gardasil. Dr. Gall said he was working on clinical trials and is a speaker for GlaxoSmithKline and Merck. The other physicians reported no disclosures.