Doug Brunk

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling baseless arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form manufactured by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form manufactured by GlaxoSmithKline Inc. that was submitted to the Food and Drug Administration in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment. Competition among manufacturers should force a reduction in prices.”

In addition, ongoing studies of more simplified schedules—such as administering two doses instead of three—may affect price.

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titers, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. Dr. Franco agreed but said that recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” he said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” Dr. Franco said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point.”

▸ There is no cervical cancer epidemic. He responds to this argument by emphasizing that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action. Moreover, he said, the HPV vaccination is likely to exert protection against other neoplastic diseases such as malignant anogenital and oropharyngeal cancer and benign genital warts and laryngeal papillomatosis.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

The HPV vaccine 'may achieve unprecedented lifelong protection.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling baseless arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form manufactured by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form manufactured by GlaxoSmithKline Inc. that was submitted to the Food and Drug Administration in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment. Competition among manufacturers should force a reduction in prices.”

In addition, ongoing studies of more simplified schedules—such as administering two doses instead of three—may affect price.

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titers, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. Dr. Franco agreed but said that recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” he said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” Dr. Franco said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point.”

▸ There is no cervical cancer epidemic. He responds to this argument by emphasizing that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action. Moreover, he said, the HPV vaccination is likely to exert protection against other neoplastic diseases such as malignant anogenital and oropharyngeal cancer and benign genital warts and laryngeal papillomatosis.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

The HPV vaccine 'may achieve unprecedented lifelong protection.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling baseless arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form manufactured by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form manufactured by GlaxoSmithKline Inc. that was submitted to the Food and Drug Administration in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment. Competition among manufacturers should force a reduction in prices.”

In addition, ongoing studies of more simplified schedules—such as administering two doses instead of three—may affect price.

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titers, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. Dr. Franco agreed but said that recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” he said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” Dr. Franco said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point.”

▸ There is no cervical cancer epidemic. He responds to this argument by emphasizing that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action. Moreover, he said, the HPV vaccination is likely to exert protection against other neoplastic diseases such as malignant anogenital and oropharyngeal cancer and benign genital warts and laryngeal papillomatosis.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

The HPV vaccine 'may achieve unprecedented lifelong protection.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form made by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form made by GlaxoSmithKline that was submitted to the FDA in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the CDC's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment.”

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titres, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” Dr. Franco said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point,” he explained.

▸ There is no cervical cancer epidemic. Dr. Franco asserts that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action and that the HPV vaccination is likely to exert protection against other neoplastic diseases such as oropharyngeal cancer and benign genital warts.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'It may be the most scrutinized vaccine by the public and the media concerning need and safety.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form made by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form made by GlaxoSmithKline that was submitted to the FDA in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the CDC's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment.”

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titres, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” Dr. Franco said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point,” he explained.

▸ There is no cervical cancer epidemic. Dr. Franco asserts that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action and that the HPV vaccination is likely to exert protection against other neoplastic diseases such as oropharyngeal cancer and benign genital warts.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'It may be the most scrutinized vaccine by the public and the media concerning need and safety.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of his time dispelling arguments and protests from other health care professionals and patients that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

“Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention,” Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. “The standard of proof is far more rigorous than that used in evaluation of candidate vaccines of the past. It may be the most scrutinized vaccine by the public and the media concerning need and safety.”

Prophylactic HPV vaccines include a quadrivalent form made by Merck & Co. that was licensed in the United States in June 2006 and a bivalent form made by GlaxoSmithKline that was submitted to the FDA in March 2007.

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the CDC's Vaccines for Children Program, the Global Alliance for Vaccines and Immunization, and the Pan American Health Organization's revolving fund should help to lower the cost. “Historically,” he added, “prices decline with time since deployment.”

Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. “Even with lowered antibody titres, postvaccination protection has continued unabated,” said Dr. Franco, who also is a professor of epidemiology and oncology at McGill. “We did not wait for such proof before deploying other vaccines.”

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers. That protection “is likely to be expanded via cross-protection,” he said. “In combination with tailored screening strategies, it may achieve unprecedented lifelong protection.”

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage “will permit extending screening intervals safely and cost effectively. Proper integration of primary and secondary prevention strategies is likely to reduce costs and improve cervical cancer control.”

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. In fact, Dr. Franco said, type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. “Several studies have tested this hypothesis,” he noted. “The fraction of the population not exposed to HPV 16 or 18 is always high; exposure to HPV 16 or 18 does not constrain the pool of susceptible individuals who could acquire other HPVs.”

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. This age group is not at risk for lesions and monitoring them “would be unethical and unproductive,” Dr. Franco said. “Immunobridging” studies show that vaccine-induced humoral response in preteens is the highest among all groups, “which is sufficient justification for expectation of benefit,” he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence. “Sensible judgment based on understanding of the natural history of HPV infection and cervical cancer indicates that prevention of precancerous lesions is an acceptable end point,” he explained.

▸ There is no cervical cancer epidemic. Dr. Franco asserts that the health costs, morbidity, and mortality associated with cervical cancer are sufficiently important to justify action and that the HPV vaccination is likely to exert protection against other neoplastic diseases such as oropharyngeal cancer and benign genital warts.

▸ More research is needed on safety. Dr. Franco responds to this argument by noting that the safety data on the HPV vaccine “are among the most well documented for any new vaccine. There was no waiting period for the adoption of other vaccines with lesser standards of proof. Inaction has a high cost in terms of morbidity and mortality that could have been averted.”

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has received a Distinguished Scientist salary award from the CIHR and has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'It may be the most scrutinized vaccine by the public and the media concerning need and safety.' DR. FRANCO

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

SAN DIEGO — A new technology platform for treating abdominal aortic aneurysms that mimics a hand-sewn anastomosis appears safe and effective, results from a phase I multicenter trial showed.

The Aptus Endovascular AAA Repair System (Aptus Endosystems Inc.) is a three-piece modular device with an unsupported main body and two fully supported limbs in a 5.3-mm outside diameter (16 Fr) delivery system.

“This system represents a new endovascular capability: the ability to attach one object to another with a device independent of the objects being attached,” Dr. David H. Deaton reported at the Vascular Annual Meeting. “In our minds it's a faithful reproduction of transmural, interrupted suture and it gives the operator a new level of control.”

With this technology, helical staples with a 4-mm depth are delivered through an independent stapling system. The location and number of staples are controlled by the operator and provide for endograft fixation and sealing that can be customized to the anatomical challenges of each patient.

“This helical incorporation of tissue holds both graft to aorta and aorta to graft, which has the potential to eliminate neck dilation,” said Dr. Deaton, chief of endovascular surgery at Georgetown University Hospital, Washington, and one of the study investigators.

In a study conducted at five centers in the United States, Dr. Deaton and his associates enrolled 21 patients with a proximal aortic neck length of 12 mm and an iliac landing zone of 10 mm. He reported on 6-month safety and feasibility data in all patients and 1-year follow-up in 14 patients. Secondary end points included freedom from endoleaks, rupture, migration, and device integrity. The mean age of patients was 75 years and 95% were men. The mean diameter of their aneurysms was 56 mm.

Dr. Deaton reported that the endograft was successfully deployed with the Aptus system in all patients without conversion. A median of 4 staples per patient was used, with a range of 2–10. Significant reduction of aneurysm size occurred in 43% of the patients at 6 months and 69% of patients at 1 year. No aneurysm enlargement was seen during either time period.

Two proximal cuffs and one limb extension were used as adjunctive devices at implantation, and three secondary interventions were performed in two patients for limb thrombosis. There were four type II endoleaks at 6 months and one type II endoleak at 1 year, but there were no type I, II, or IV endoleaks. There were no adverse events, device integrity failures, or migration.

“One of the real benefits of an independent fixation system is [that it allows] a significant reduction in the caliber of graft delivery catheters,” Dr. Deaton said. “It also allows you to reposition the proximal stent without an advanced delivery catheter.”

Dr. Deaton is a consultant to Aptus Endosystems Inc. and serves on the company's advisory board.

SAN DIEGO — A new technology platform for treating abdominal aortic aneurysms that mimics a hand-sewn anastomosis appears safe and effective, results from a phase I multicenter trial showed.

The Aptus Endovascular AAA Repair System (Aptus Endosystems Inc.) is a three-piece modular device with an unsupported main body and two fully supported limbs in a 5.3-mm outside diameter (16 Fr) delivery system.

“This system represents a new endovascular capability: the ability to attach one object to another with a device independent of the objects being attached,” Dr. David H. Deaton reported at the Vascular Annual Meeting. “In our minds it's a faithful reproduction of transmural, interrupted suture and it gives the operator a new level of control.”

With this technology, helical staples with a 4-mm depth are delivered through an independent stapling system. The location and number of staples are controlled by the operator and provide for endograft fixation and sealing that can be customized to the anatomical challenges of each patient.

“This helical incorporation of tissue holds both graft to aorta and aorta to graft, which has the potential to eliminate neck dilation,” said Dr. Deaton, chief of endovascular surgery at Georgetown University Hospital, Washington, and one of the study investigators.

In a study conducted at five centers in the United States, Dr. Deaton and his associates enrolled 21 patients with a proximal aortic neck length of 12 mm and an iliac landing zone of 10 mm. He reported on 6-month safety and feasibility data in all patients and 1-year follow-up in 14 patients. Secondary end points included freedom from endoleaks, rupture, migration, and device integrity. The mean age of patients was 75 years and 95% were men. The mean diameter of their aneurysms was 56 mm.

Dr. Deaton reported that the endograft was successfully deployed with the Aptus system in all patients without conversion. A median of 4 staples per patient was used, with a range of 2–10. Significant reduction of aneurysm size occurred in 43% of the patients at 6 months and 69% of patients at 1 year. No aneurysm enlargement was seen during either time period.

Two proximal cuffs and one limb extension were used as adjunctive devices at implantation, and three secondary interventions were performed in two patients for limb thrombosis. There were four type II endoleaks at 6 months and one type II endoleak at 1 year, but there were no type I, II, or IV endoleaks. There were no adverse events, device integrity failures, or migration.

“One of the real benefits of an independent fixation system is [that it allows] a significant reduction in the caliber of graft delivery catheters,” Dr. Deaton said. “It also allows you to reposition the proximal stent without an advanced delivery catheter.”

Dr. Deaton is a consultant to Aptus Endosystems Inc. and serves on the company's advisory board.

SAN DIEGO — A new technology platform for treating abdominal aortic aneurysms that mimics a hand-sewn anastomosis appears safe and effective, results from a phase I multicenter trial showed.

The Aptus Endovascular AAA Repair System (Aptus Endosystems Inc.) is a three-piece modular device with an unsupported main body and two fully supported limbs in a 5.3-mm outside diameter (16 Fr) delivery system.

“This system represents a new endovascular capability: the ability to attach one object to another with a device independent of the objects being attached,” Dr. David H. Deaton reported at the Vascular Annual Meeting. “In our minds it's a faithful reproduction of transmural, interrupted suture and it gives the operator a new level of control.”

With this technology, helical staples with a 4-mm depth are delivered through an independent stapling system. The location and number of staples are controlled by the operator and provide for endograft fixation and sealing that can be customized to the anatomical challenges of each patient.

“This helical incorporation of tissue holds both graft to aorta and aorta to graft, which has the potential to eliminate neck dilation,” said Dr. Deaton, chief of endovascular surgery at Georgetown University Hospital, Washington, and one of the study investigators.

In a study conducted at five centers in the United States, Dr. Deaton and his associates enrolled 21 patients with a proximal aortic neck length of 12 mm and an iliac landing zone of 10 mm. He reported on 6-month safety and feasibility data in all patients and 1-year follow-up in 14 patients. Secondary end points included freedom from endoleaks, rupture, migration, and device integrity. The mean age of patients was 75 years and 95% were men. The mean diameter of their aneurysms was 56 mm.

Dr. Deaton reported that the endograft was successfully deployed with the Aptus system in all patients without conversion. A median of 4 staples per patient was used, with a range of 2–10. Significant reduction of aneurysm size occurred in 43% of the patients at 6 months and 69% of patients at 1 year. No aneurysm enlargement was seen during either time period.

Two proximal cuffs and one limb extension were used as adjunctive devices at implantation, and three secondary interventions were performed in two patients for limb thrombosis. There were four type II endoleaks at 6 months and one type II endoleak at 1 year, but there were no type I, II, or IV endoleaks. There were no adverse events, device integrity failures, or migration.

“One of the real benefits of an independent fixation system is [that it allows] a significant reduction in the caliber of graft delivery catheters,” Dr. Deaton said. “It also allows you to reposition the proximal stent without an advanced delivery catheter.”

Dr. Deaton is a consultant to Aptus Endosystems Inc. and serves on the company's advisory board.

Twenty-one percent of internationally adopted children demonstrated evidence of latent tuberculosis infection on their first tuberculin skin test, results from a single-center study showed.

Moreover, the rate of latent TB infection in those who were retested at least 3 months after a second tuberculin skin test (TST) was 20%.

The findings underscore the need for internationally adopted children to be tested for TB when they arrive in the United States, according to investigator Dr. Indi Trehan of the department of pediatrics at Cincinnati Children's Hospital Medical Center and his associates.

“TB screening is important, and it should be viewed in the context of postinstitutionalized children,” Dr. Todd J. Ochs, a Chicago-based adoption pediatrician who was not affiliated with the study, said in an interview.

“Intestinal parasites, especially Giardia lamblia, potential exposure to HIV, hepatitis B and C, syphilis, malnutrition (kwashiorkor and marasmus), developmental delays, and emotional and psychological problems, all are seen in these children.

“The mantra when assessing them should be 'remember who I was, not who I am,'” Dr. Ochs commented.

Dr. Trehan and his associates evaluated 527 children at the University of Cincinnati's International Adoption Center who had an initial TST within 2 months of arriving in the United States (Pediatrics 2008;122:e7-e14 [doi:10.1542/peds.2007-1338

A repeat TST at least 3 months after the initial one was recommended for those whose initial test was negative or not read.

The mean age of the children was 23 months and 54% were female. Most were from Russia, China, Guatemala, Kazakhstan, and South Korea.

Of the 527 children, 111 (21%) had evidence of latent TB infection after their initial TST.

Of the 416 children with an initially negative TST, only 191 (46%) had a repeat test performed and read at least 3 months after their initial TST, even though the researchers recommended repeat testing to adoptive parents and their primary care physicians.

Of these, 38 (20%) had evidence of latent TB infection.

“Presumably, these children were not exposed to TB in the United States but instead, at this later date, were better able to mount an appropriate delayed hypersensitivity response to the TST,” the researchers commented. “The hypothesis that this is perhaps a result of improved nutrition is supported by our data showing that those with an initially positive TST result had a higher weight-for-age z score (−1.13 vs. −1.38).”

Dr. Ochs, who is the father of four internationally adopted daughters and one biological daughter, noted that when most internationally adopted children present to physician offices, “it's very rare that there is family history, so we're seeing children who we know nothing about and we're trying to assess their health. They all need infectious diseases screening. They all need eye exams, hearing exams, developmental evaluations. Many of them also need psychological support. We need to be meticulous with these kids.”

He recommends administering a repeat TST 6 months after the initial test in internationally adopted children as well as in foster children, “who may have had multiple placements.

“They may have entered the health care system because they were being handed off from one caregiver to another and may have been exposed to tuberculosis,” Dr. Ochs said.

Children should be considered a high-priority group for treatment of TB not only because of their risk for severe disease and lifetime risk for reactivation of disease, but also because they often serve as index cases for widespread transmission of TB, the investigators commented.

Twenty-one percent of internationally adopted children demonstrated evidence of latent tuberculosis infection on their first tuberculin skin test, results from a single-center study showed.

Moreover, the rate of latent TB infection in those who were retested at least 3 months after a second tuberculin skin test (TST) was 20%.

The findings underscore the need for internationally adopted children to be tested for TB when they arrive in the United States, according to investigator Dr. Indi Trehan of the department of pediatrics at Cincinnati Children's Hospital Medical Center and his associates.

“TB screening is important, and it should be viewed in the context of postinstitutionalized children,” Dr. Todd J. Ochs, a Chicago-based adoption pediatrician who was not affiliated with the study, said in an interview.

“Intestinal parasites, especially Giardia lamblia, potential exposure to HIV, hepatitis B and C, syphilis, malnutrition (kwashiorkor and marasmus), developmental delays, and emotional and psychological problems, all are seen in these children.

“The mantra when assessing them should be 'remember who I was, not who I am,'” Dr. Ochs commented.

Dr. Trehan and his associates evaluated 527 children at the University of Cincinnati's International Adoption Center who had an initial TST within 2 months of arriving in the United States (Pediatrics 2008;122:e7-e14 [doi:10.1542/peds.2007-1338

A repeat TST at least 3 months after the initial one was recommended for those whose initial test was negative or not read.

The mean age of the children was 23 months and 54% were female. Most were from Russia, China, Guatemala, Kazakhstan, and South Korea.

Of the 527 children, 111 (21%) had evidence of latent TB infection after their initial TST.

Of the 416 children with an initially negative TST, only 191 (46%) had a repeat test performed and read at least 3 months after their initial TST, even though the researchers recommended repeat testing to adoptive parents and their primary care physicians.

Of these, 38 (20%) had evidence of latent TB infection.

“Presumably, these children were not exposed to TB in the United States but instead, at this later date, were better able to mount an appropriate delayed hypersensitivity response to the TST,” the researchers commented. “The hypothesis that this is perhaps a result of improved nutrition is supported by our data showing that those with an initially positive TST result had a higher weight-for-age z score (−1.13 vs. −1.38).”

Dr. Ochs, who is the father of four internationally adopted daughters and one biological daughter, noted that when most internationally adopted children present to physician offices, “it's very rare that there is family history, so we're seeing children who we know nothing about and we're trying to assess their health. They all need infectious diseases screening. They all need eye exams, hearing exams, developmental evaluations. Many of them also need psychological support. We need to be meticulous with these kids.”

He recommends administering a repeat TST 6 months after the initial test in internationally adopted children as well as in foster children, “who may have had multiple placements.

“They may have entered the health care system because they were being handed off from one caregiver to another and may have been exposed to tuberculosis,” Dr. Ochs said.

Children should be considered a high-priority group for treatment of TB not only because of their risk for severe disease and lifetime risk for reactivation of disease, but also because they often serve as index cases for widespread transmission of TB, the investigators commented.

Twenty-one percent of internationally adopted children demonstrated evidence of latent tuberculosis infection on their first tuberculin skin test, results from a single-center study showed.

Moreover, the rate of latent TB infection in those who were retested at least 3 months after a second tuberculin skin test (TST) was 20%.

The findings underscore the need for internationally adopted children to be tested for TB when they arrive in the United States, according to investigator Dr. Indi Trehan of the department of pediatrics at Cincinnati Children's Hospital Medical Center and his associates.

“TB screening is important, and it should be viewed in the context of postinstitutionalized children,” Dr. Todd J. Ochs, a Chicago-based adoption pediatrician who was not affiliated with the study, said in an interview.

“Intestinal parasites, especially Giardia lamblia, potential exposure to HIV, hepatitis B and C, syphilis, malnutrition (kwashiorkor and marasmus), developmental delays, and emotional and psychological problems, all are seen in these children.

“The mantra when assessing them should be 'remember who I was, not who I am,'” Dr. Ochs commented.

Dr. Trehan and his associates evaluated 527 children at the University of Cincinnati's International Adoption Center who had an initial TST within 2 months of arriving in the United States (Pediatrics 2008;122:e7-e14 [doi:10.1542/peds.2007-1338

A repeat TST at least 3 months after the initial one was recommended for those whose initial test was negative or not read.

The mean age of the children was 23 months and 54% were female. Most were from Russia, China, Guatemala, Kazakhstan, and South Korea.

Of the 527 children, 111 (21%) had evidence of latent TB infection after their initial TST.

Of the 416 children with an initially negative TST, only 191 (46%) had a repeat test performed and read at least 3 months after their initial TST, even though the researchers recommended repeat testing to adoptive parents and their primary care physicians.

Of these, 38 (20%) had evidence of latent TB infection.

“Presumably, these children were not exposed to TB in the United States but instead, at this later date, were better able to mount an appropriate delayed hypersensitivity response to the TST,” the researchers commented. “The hypothesis that this is perhaps a result of improved nutrition is supported by our data showing that those with an initially positive TST result had a higher weight-for-age z score (−1.13 vs. −1.38).”

Dr. Ochs, who is the father of four internationally adopted daughters and one biological daughter, noted that when most internationally adopted children present to physician offices, “it's very rare that there is family history, so we're seeing children who we know nothing about and we're trying to assess their health. They all need infectious diseases screening. They all need eye exams, hearing exams, developmental evaluations. Many of them also need psychological support. We need to be meticulous with these kids.”

He recommends administering a repeat TST 6 months after the initial test in internationally adopted children as well as in foster children, “who may have had multiple placements.

“They may have entered the health care system because they were being handed off from one caregiver to another and may have been exposed to tuberculosis,” Dr. Ochs said.

Children should be considered a high-priority group for treatment of TB not only because of their risk for severe disease and lifetime risk for reactivation of disease, but also because they often serve as index cases for widespread transmission of TB, the investigators commented.

Faced with 15%-18% average yearly increases in the health insurance premiums he pays for his staff, Dr. John K. Randall decided to do something about it.

He staged a weight loss contest, loosely modeled after the fitness reality television show, “The Biggest Loser.” Fourteen employees who elected to participate ponied up a $20 entrance fee each and were weighed on Feb. 4, 2008, and again on June 4, 2008–the end of the competition. Dr. Randall added $500 to sweeten the pot.

Karen Cooper, a receptionist at Randall Dermatology's Kokomo, Ind., office, earned the $780 prize and the designation of the practice's “Biggest Loser” by shedding 33 pounds and dropping her body mass index from 36 kg/m

The runners-up shed 19 and 17 pounds, respectively.

“Happy employees and those who are motivated to promote your practice go a long way in making you successful,” said Dr. Randall, who employs 40 people in five main offices and seven satellite offices in Indiana. “The health part of that is very important. Getting people healthier will end up costing me less money in the long run.”

Dr. Randall noted that a sense of solidarity developed among the contestants. “A lot of people were involved, and they had something in common,” he said. “Almost half of the employees were working toward a similar goal, so I think it made a difference in a positive way. It wasn't cutthroat competition.”

Some of the contestants used a dedicated workout room that was added to Randall Dermatology's West Lafayette location during a recent renovation. It contains state-of-the-art fitness equipment and is open to all employees. As an additional incentive during the contest period, Dr. Randall paid the registration fee for employees to participate in a 5K run that supported the local March of Dimes.

“That encouraged them to show up and to train for a little bit of running,” he said.

Dr. Randall said that keeping the weight loss contest simple made it successful. “Don't require people to come in every week and keep a log of what they're eating or how much they're exercising,” he advised. “Pick out a specific amount of time so people have a goal. I think at least 3 months, but up to 6 months would be reasonable.”

When the winner of Dr. Randall's weight loss competition learned about the contest, she signed up right away.

“I needed to lose the weight,” Ms. Cooper said. “I figured this was as good a time as any to get started. Competition is good.”

Ms. Cooper credits her achievement to carefully watching her caloric intake and taking brisk walks.

“My daughter is a dietician and the first thing she said was, 'Mom, calories count. It doesn't matter if a food is fat free or not. You've got to watch the intake.'

“So I counted my calories and exercised. I tried to make it vigorous.”

During a visit to her physician after the contest ended, Ms. Cooper said she learned that her triglyceride levels were “awesome.”

“My numbers have always been really high,” she said. “We have heart disease in my family, and my numbers were right in the normal range. My doctor was thrilled.”

Dr. John K. Randall, shown here with “Biggest Loser” Karen Cooper (left) and contest runner-up Lara Rogers, added a workout facility to his dermatology practice. Lynn Coons

Faced with 15%-18% average yearly increases in the health insurance premiums he pays for his staff, Dr. John K. Randall decided to do something about it.

He staged a weight loss contest, loosely modeled after the fitness reality television show, “The Biggest Loser.” Fourteen employees who elected to participate ponied up a $20 entrance fee each and were weighed on Feb. 4, 2008, and again on June 4, 2008–the end of the competition. Dr. Randall added $500 to sweeten the pot.

Karen Cooper, a receptionist at Randall Dermatology's Kokomo, Ind., office, earned the $780 prize and the designation of the practice's “Biggest Loser” by shedding 33 pounds and dropping her body mass index from 36 kg/m

The runners-up shed 19 and 17 pounds, respectively.

“Happy employees and those who are motivated to promote your practice go a long way in making you successful,” said Dr. Randall, who employs 40 people in five main offices and seven satellite offices in Indiana. “The health part of that is very important. Getting people healthier will end up costing me less money in the long run.”

Dr. Randall noted that a sense of solidarity developed among the contestants. “A lot of people were involved, and they had something in common,” he said. “Almost half of the employees were working toward a similar goal, so I think it made a difference in a positive way. It wasn't cutthroat competition.”

Some of the contestants used a dedicated workout room that was added to Randall Dermatology's West Lafayette location during a recent renovation. It contains state-of-the-art fitness equipment and is open to all employees. As an additional incentive during the contest period, Dr. Randall paid the registration fee for employees to participate in a 5K run that supported the local March of Dimes.

“That encouraged them to show up and to train for a little bit of running,” he said.

Dr. Randall said that keeping the weight loss contest simple made it successful. “Don't require people to come in every week and keep a log of what they're eating or how much they're exercising,” he advised. “Pick out a specific amount of time so people have a goal. I think at least 3 months, but up to 6 months would be reasonable.”

When the winner of Dr. Randall's weight loss competition learned about the contest, she signed up right away.

“I needed to lose the weight,” Ms. Cooper said. “I figured this was as good a time as any to get started. Competition is good.”

Ms. Cooper credits her achievement to carefully watching her caloric intake and taking brisk walks.

“My daughter is a dietician and the first thing she said was, 'Mom, calories count. It doesn't matter if a food is fat free or not. You've got to watch the intake.'

“So I counted my calories and exercised. I tried to make it vigorous.”

During a visit to her physician after the contest ended, Ms. Cooper said she learned that her triglyceride levels were “awesome.”

“My numbers have always been really high,” she said. “We have heart disease in my family, and my numbers were right in the normal range. My doctor was thrilled.”

Dr. John K. Randall, shown here with “Biggest Loser” Karen Cooper (left) and contest runner-up Lara Rogers, added a workout facility to his dermatology practice. Lynn Coons

Faced with 15%-18% average yearly increases in the health insurance premiums he pays for his staff, Dr. John K. Randall decided to do something about it.

He staged a weight loss contest, loosely modeled after the fitness reality television show, “The Biggest Loser.” Fourteen employees who elected to participate ponied up a $20 entrance fee each and were weighed on Feb. 4, 2008, and again on June 4, 2008–the end of the competition. Dr. Randall added $500 to sweeten the pot.

Karen Cooper, a receptionist at Randall Dermatology's Kokomo, Ind., office, earned the $780 prize and the designation of the practice's “Biggest Loser” by shedding 33 pounds and dropping her body mass index from 36 kg/m

The runners-up shed 19 and 17 pounds, respectively.

“Happy employees and those who are motivated to promote your practice go a long way in making you successful,” said Dr. Randall, who employs 40 people in five main offices and seven satellite offices in Indiana. “The health part of that is very important. Getting people healthier will end up costing me less money in the long run.”

Dr. Randall noted that a sense of solidarity developed among the contestants. “A lot of people were involved, and they had something in common,” he said. “Almost half of the employees were working toward a similar goal, so I think it made a difference in a positive way. It wasn't cutthroat competition.”

Some of the contestants used a dedicated workout room that was added to Randall Dermatology's West Lafayette location during a recent renovation. It contains state-of-the-art fitness equipment and is open to all employees. As an additional incentive during the contest period, Dr. Randall paid the registration fee for employees to participate in a 5K run that supported the local March of Dimes.

“That encouraged them to show up and to train for a little bit of running,” he said.

Dr. Randall said that keeping the weight loss contest simple made it successful. “Don't require people to come in every week and keep a log of what they're eating or how much they're exercising,” he advised. “Pick out a specific amount of time so people have a goal. I think at least 3 months, but up to 6 months would be reasonable.”

When the winner of Dr. Randall's weight loss competition learned about the contest, she signed up right away.

“I needed to lose the weight,” Ms. Cooper said. “I figured this was as good a time as any to get started. Competition is good.”

Ms. Cooper credits her achievement to carefully watching her caloric intake and taking brisk walks.

“My daughter is a dietician and the first thing she said was, 'Mom, calories count. It doesn't matter if a food is fat free or not. You've got to watch the intake.'

“So I counted my calories and exercised. I tried to make it vigorous.”

During a visit to her physician after the contest ended, Ms. Cooper said she learned that her triglyceride levels were “awesome.”

“My numbers have always been really high,” she said. “We have heart disease in my family, and my numbers were right in the normal range. My doctor was thrilled.”

Dr. John K. Randall, shown here with “Biggest Loser” Karen Cooper (left) and contest runner-up Lara Rogers, added a workout facility to his dermatology practice. Lynn Coons

SALT LAKE CITY – Diagnosing frailty in a nursing home resident can be a time-consuming undertaking.

According to Dr. John E. Morley, a generally accepted definition of frailty is useful but not practical for most nursing homes because they don't have the time or the staff to test for the criteria that constitute that definition.

“Unless someone's reimbursing you, you probably don't have the time to do this in your practice,” Dr. Morley said at the annual symposium of the American Medical Directors Association.

Dr. Morley, a professor of gerontology at St. Louis University, was referring to the criteria set forth by Dr. Linda P. Fried of the Johns Hopkins Medical Institutions and her associates in 2001. They characterized frailty in older adults as a clinical syndrome occurring when three or more of the following criteria are present: unintentional loss of at least 10 pounds in the past year, self-report of exhaustion, extremely weak grip strength, slow walking speed over 15 feet, and low physical activity as measured by calories expended per week (J. Gerontol. A Biol. Sci. Med. Sci.2001;56:M146-57).

Instead, Dr. Morley suggested a frailty screening tool developed by the International Academy of Nutrition and Aging, based on simpler answers to questions suggested by the mnemonic FRAIL. F stands for fatigue (Is the person fatigued?); R for resistance (Can the person walk up at least one flight of stairs?); A for aerobic (Can the person walk at least one block?); I for illness (Does the person have more than five illnesses?); and L for loss of weight (Has the person lost more than 5% of his or her weight in the past year?) (J. Am. Med. Dir. Assoc. 2008;9:71-2).

“If you want to measure for frailty quickly in the nursing home setting, this is a nice way to do it,” said Dr. Morley, who is editor in chief of the Journal of the American Medical Directors Association. He noted that validation studies of the screening tool are currently underway. He said it's already clear that the tool “is far more useful than an echocardiogram” in revealing frailty.

Measuring frailty is important because of its direct link to poor nutrition, he said. Recent studies have demonstrated that frail older people consume fewer than 21 kcal/day and have lower than normal intake of protein; vitamins D, E, and C; and folate. “We should be pushing for a balanced diet,” rather than just administering multivitamins, he said. “Much of the literature that's coming out suggests that balanced diet is what matters.”

Eating right is hard to do for anyone, let alone a frail elderly person, he added. “If you look at what the average American eats, we often don't come close to five servings of fruits and vegetables a day.”

Weight loss in nursing home residents is a matter of major concern. A study of underweight nursing home residents found that 30% of residents who continued to lose weight died over the next 6 months, while the 6-month mortality rate was 20% among those whose weight stabilized, and 10% among people whose weight loss was reversed (J. Nutr. Health Aging 2002;6:275-81).

Causes of weight loss include anorexia, cachexia, rheumatoid cachexia, sarcopenia, malabsorption, hypermetabolism, and dehydration. “It is now well recognized that not only is weight loss bad for nursing home residents, but anorexia independently predicts mortality at a slightly higher hazard ratio than weight loss,” Dr. Morley said.

He recommends the Simplified Nutritional Appetite Questionnaire (SNAQ) as a “simple, easy” way to screen for anorexia. Developed by the Council for Nutritional Strategies in Long-Term Care, this tool is a four-item, single-domain questionnaire. Responses are scored by using a 5-point, verbally labeled Likert-type scale, low scores indicating deterioration in appetite (Am. J. Clin. Nutr. 2005;82:1074-81).

The SNAQ “has very good sensitivity and specificity for weight loss, and it can predict weight loss 6 months down the line,” Dr. Morley said.

'Unless someone's reimbursing you, you probably don't have the time to do this in your practice.' DR. MORLEY

SALT LAKE CITY – Diagnosing frailty in a nursing home resident can be a time-consuming undertaking.

According to Dr. John E. Morley, a generally accepted definition of frailty is useful but not practical for most nursing homes because they don't have the time or the staff to test for the criteria that constitute that definition.

“Unless someone's reimbursing you, you probably don't have the time to do this in your practice,” Dr. Morley said at the annual symposium of the American Medical Directors Association.

Dr. Morley, a professor of gerontology at St. Louis University, was referring to the criteria set forth by Dr. Linda P. Fried of the Johns Hopkins Medical Institutions and her associates in 2001. They characterized frailty in older adults as a clinical syndrome occurring when three or more of the following criteria are present: unintentional loss of at least 10 pounds in the past year, self-report of exhaustion, extremely weak grip strength, slow walking speed over 15 feet, and low physical activity as measured by calories expended per week (J. Gerontol. A Biol. Sci. Med. Sci.2001;56:M146-57).

Instead, Dr. Morley suggested a frailty screening tool developed by the International Academy of Nutrition and Aging, based on simpler answers to questions suggested by the mnemonic FRAIL. F stands for fatigue (Is the person fatigued?); R for resistance (Can the person walk up at least one flight of stairs?); A for aerobic (Can the person walk at least one block?); I for illness (Does the person have more than five illnesses?); and L for loss of weight (Has the person lost more than 5% of his or her weight in the past year?) (J. Am. Med. Dir. Assoc. 2008;9:71-2).

“If you want to measure for frailty quickly in the nursing home setting, this is a nice way to do it,” said Dr. Morley, who is editor in chief of the Journal of the American Medical Directors Association. He noted that validation studies of the screening tool are currently underway. He said it's already clear that the tool “is far more useful than an echocardiogram” in revealing frailty.

Measuring frailty is important because of its direct link to poor nutrition, he said. Recent studies have demonstrated that frail older people consume fewer than 21 kcal/day and have lower than normal intake of protein; vitamins D, E, and C; and folate. “We should be pushing for a balanced diet,” rather than just administering multivitamins, he said. “Much of the literature that's coming out suggests that balanced diet is what matters.”

Eating right is hard to do for anyone, let alone a frail elderly person, he added. “If you look at what the average American eats, we often don't come close to five servings of fruits and vegetables a day.”

Weight loss in nursing home residents is a matter of major concern. A study of underweight nursing home residents found that 30% of residents who continued to lose weight died over the next 6 months, while the 6-month mortality rate was 20% among those whose weight stabilized, and 10% among people whose weight loss was reversed (J. Nutr. Health Aging 2002;6:275-81).

Causes of weight loss include anorexia, cachexia, rheumatoid cachexia, sarcopenia, malabsorption, hypermetabolism, and dehydration. “It is now well recognized that not only is weight loss bad for nursing home residents, but anorexia independently predicts mortality at a slightly higher hazard ratio than weight loss,” Dr. Morley said.

He recommends the Simplified Nutritional Appetite Questionnaire (SNAQ) as a “simple, easy” way to screen for anorexia. Developed by the Council for Nutritional Strategies in Long-Term Care, this tool is a four-item, single-domain questionnaire. Responses are scored by using a 5-point, verbally labeled Likert-type scale, low scores indicating deterioration in appetite (Am. J. Clin. Nutr. 2005;82:1074-81).

The SNAQ “has very good sensitivity and specificity for weight loss, and it can predict weight loss 6 months down the line,” Dr. Morley said.

'Unless someone's reimbursing you, you probably don't have the time to do this in your practice.' DR. MORLEY

SALT LAKE CITY – Diagnosing frailty in a nursing home resident can be a time-consuming undertaking.

According to Dr. John E. Morley, a generally accepted definition of frailty is useful but not practical for most nursing homes because they don't have the time or the staff to test for the criteria that constitute that definition.

“Unless someone's reimbursing you, you probably don't have the time to do this in your practice,” Dr. Morley said at the annual symposium of the American Medical Directors Association.

Dr. Morley, a professor of gerontology at St. Louis University, was referring to the criteria set forth by Dr. Linda P. Fried of the Johns Hopkins Medical Institutions and her associates in 2001. They characterized frailty in older adults as a clinical syndrome occurring when three or more of the following criteria are present: unintentional loss of at least 10 pounds in the past year, self-report of exhaustion, extremely weak grip strength, slow walking speed over 15 feet, and low physical activity as measured by calories expended per week (J. Gerontol. A Biol. Sci. Med. Sci.2001;56:M146-57).

Instead, Dr. Morley suggested a frailty screening tool developed by the International Academy of Nutrition and Aging, based on simpler answers to questions suggested by the mnemonic FRAIL. F stands for fatigue (Is the person fatigued?); R for resistance (Can the person walk up at least one flight of stairs?); A for aerobic (Can the person walk at least one block?); I for illness (Does the person have more than five illnesses?); and L for loss of weight (Has the person lost more than 5% of his or her weight in the past year?) (J. Am. Med. Dir. Assoc. 2008;9:71-2).

“If you want to measure for frailty quickly in the nursing home setting, this is a nice way to do it,” said Dr. Morley, who is editor in chief of the Journal of the American Medical Directors Association. He noted that validation studies of the screening tool are currently underway. He said it's already clear that the tool “is far more useful than an echocardiogram” in revealing frailty.

Measuring frailty is important because of its direct link to poor nutrition, he said. Recent studies have demonstrated that frail older people consume fewer than 21 kcal/day and have lower than normal intake of protein; vitamins D, E, and C; and folate. “We should be pushing for a balanced diet,” rather than just administering multivitamins, he said. “Much of the literature that's coming out suggests that balanced diet is what matters.”

Eating right is hard to do for anyone, let alone a frail elderly person, he added. “If you look at what the average American eats, we often don't come close to five servings of fruits and vegetables a day.”

Weight loss in nursing home residents is a matter of major concern. A study of underweight nursing home residents found that 30% of residents who continued to lose weight died over the next 6 months, while the 6-month mortality rate was 20% among those whose weight stabilized, and 10% among people whose weight loss was reversed (J. Nutr. Health Aging 2002;6:275-81).

Causes of weight loss include anorexia, cachexia, rheumatoid cachexia, sarcopenia, malabsorption, hypermetabolism, and dehydration. “It is now well recognized that not only is weight loss bad for nursing home residents, but anorexia independently predicts mortality at a slightly higher hazard ratio than weight loss,” Dr. Morley said.

He recommends the Simplified Nutritional Appetite Questionnaire (SNAQ) as a “simple, easy” way to screen for anorexia. Developed by the Council for Nutritional Strategies in Long-Term Care, this tool is a four-item, single-domain questionnaire. Responses are scored by using a 5-point, verbally labeled Likert-type scale, low scores indicating deterioration in appetite (Am. J. Clin. Nutr. 2005;82:1074-81).

The SNAQ “has very good sensitivity and specificity for weight loss, and it can predict weight loss 6 months down the line,” Dr. Morley said.

'Unless someone's reimbursing you, you probably don't have the time to do this in your practice.' DR. MORLEY

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of time arguing with health care professionals and patients who say that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

"Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention," Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past."

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program and the Pan American Health Organization's revolving fund should help to lower the cost. "Historically," he added, "prices decline with time since deployment."

In addition, ongoing studies of simplified schedules—such as administering two doses instead of three—may affect price. Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. "Even with lowered antibody titers, postvaccination protection has continued unabated," said Dr. Franco, who also is a professor of epidemiology and oncology at McGill.

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers that "is likely to be expanded via cross-protection," he said.

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage "will permit extending screening intervals safely and cost effectively."

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. Type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. "Several studies have tested this hypothesis," he noted.

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. "Immunobridging" studies show that vaccine-induced humoral response in preteens is the highest among all groups, "which is sufficient justification for expectation of benefit," he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence.

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'Even with lowered antibody titers, postvaccination protection has continued unabated.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of time arguing with health care professionals and patients who say that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

"Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention," Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past."

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program and the Pan American Health Organization's revolving fund should help to lower the cost. "Historically," he added, "prices decline with time since deployment."

In addition, ongoing studies of simplified schedules—such as administering two doses instead of three—may affect price. Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. "Even with lowered antibody titers, postvaccination protection has continued unabated," said Dr. Franco, who also is a professor of epidemiology and oncology at McGill.

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers that "is likely to be expanded via cross-protection," he said.

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage "will permit extending screening intervals safely and cost effectively."

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. Type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. "Several studies have tested this hypothesis," he noted.

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. "Immunobridging" studies show that vaccine-induced humoral response in preteens is the highest among all groups, "which is sufficient justification for expectation of benefit," he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence.

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'Even with lowered antibody titers, postvaccination protection has continued unabated.' DR. FRANCO

CALGARY, ALTA. — As an epidemiologist whose research focuses on the prevention of cervical cancer, Dr. Eduardo L. Franco spends a lot of time arguing with health care professionals and patients who say that more research is needed before universal human papillomavirus vaccination can be recommended worldwide.

"Although clinical experience has just passed 6 years, the evidence base is one of the strongest in disease prevention," Dr. Franco said at the annual meeting of the Society of Obstetricians and Gynaecologists of Canada. "The standard of proof is far more rigorous than that used in the evaluation of candidate vaccines of the past."

Dr. Franco, director of the division of cancer epidemiology at McGill University, Montreal, shared several examples of arguments against HPV vaccination that he encounters, followed by his counterargument for each.

One chief argument he hears is that the vaccine is too costly and unaffordable where it's most needed. However, he said, procurement programs such as the Centers for Disease Control and Prevention's Vaccines for Children Program and the Pan American Health Organization's revolving fund should help to lower the cost. "Historically," he added, "prices decline with time since deployment."

In addition, ongoing studies of simplified schedules—such as administering two doses instead of three—may affect price. Other common arguments against HPV vaccination include the following:

▸ There are no data on long-term duration of protection. In fact, to date, studies demonstrate a sustained antibody response with no indication that humoral immunity will wane before 10 years. "Even with lowered antibody titers, postvaccination protection has continued unabated," said Dr. Franco, who also is a professor of epidemiology and oncology at McGill.

▸ Protection is limited; vaccines cover only two oncogenic types. In fact, protection is against the two most important types (HPV 16 and 18), which translates into a protective fraction of 70% of all cervical cancers that "is likely to be expanded via cross-protection," he said.

▸ Screening will continue to be needed. True, Dr. Franco said, but recent progress on new technologies such as HPV testing with Pap triage "will permit extending screening intervals safely and cost effectively."

▸ There is a risk of type replacement, which occurred with the pneumococcal vaccine. Type replacement is unlikely to occur because there is no epidemiologic proof that HPV types compete for specific niches. "Several studies have tested this hypothesis," he noted.

▸ We should not vaccinate preteens and teens; there are no efficacy data on patients aged 9-14 years. "Immunobridging" studies show that vaccine-induced humoral response in preteens is the highest among all groups, "which is sufficient justification for expectation of benefit," he said.

▸ There is no proof yet that vaccination can reduce the risk of invasive cancers. Dr. Franco counters this notion by pointing out that absence of evidence is not evidence of absence.

Dr. Franco disclosed that his entire research program has been funded by the Canadian Institutes of Health Research (CIHR), the National Cancer Institute of Canada, and the National Institutes of Health. He has served as an occasional adviser to several companies with products related to cervical cancer prevention.

'Even with lowered antibody titers, postvaccination protection has continued unabated.' DR. FRANCO

SAN DIEGO — Although fluid intake can be safely increased in nursing home residents who have, or are at risk for, pressure ulcers and do not routinely ingest the prescribed amount of fluid, levels of subcutaneous oxygen may remain low, results from a multicenter study showed.

“In the nursing home population, hydration is a serious issue,” Nancy A. Stotts, R.N., Ed.D., said at the annual meeting of the Wound Healing Society.

Researchers recorded fluid intake for 5 days in 64 residents of five nursing homes in Northern California. The residents were then randomized to receive, for 5 days, the target amount of fluid prescribed by their physician or the target amount plus 10 mL/kg of body weight, said Dr. Stotts, professor of nursing at the University of California, San Francisco.

Subcutaneous oxygen levels were assessed for 3 days during treatment. The mean age of patients was 79 years. The mean baseline daily fluid intake was 1,374 cc for the group who received prescribed fluid, and 1,707 cc for those who received extra fluid. After treatment, the mean daily fluid intake increased significantly for both groups: to 1,787 cc for the group who received prescribed fluid, and to 2,380 cc for those who received the extra fluid.

The mean level of subcutaneous oxygen, however, was 40 mm Hg for patients in the target prescribed group, and 36 mm Hg for patients in the supplemental fluid group. Subcutaneous oxygen levels less than 45 mm Hg indicate tissue hypoxia, she said. The study was funded by the National Institutes of Health.

SAN DIEGO — Although fluid intake can be safely increased in nursing home residents who have, or are at risk for, pressure ulcers and do not routinely ingest the prescribed amount of fluid, levels of subcutaneous oxygen may remain low, results from a multicenter study showed.

“In the nursing home population, hydration is a serious issue,” Nancy A. Stotts, R.N., Ed.D., said at the annual meeting of the Wound Healing Society.

Researchers recorded fluid intake for 5 days in 64 residents of five nursing homes in Northern California. The residents were then randomized to receive, for 5 days, the target amount of fluid prescribed by their physician or the target amount plus 10 mL/kg of body weight, said Dr. Stotts, professor of nursing at the University of California, San Francisco.

Subcutaneous oxygen levels were assessed for 3 days during treatment. The mean age of patients was 79 years. The mean baseline daily fluid intake was 1,374 cc for the group who received prescribed fluid, and 1,707 cc for those who received extra fluid. After treatment, the mean daily fluid intake increased significantly for both groups: to 1,787 cc for the group who received prescribed fluid, and to 2,380 cc for those who received the extra fluid.

The mean level of subcutaneous oxygen, however, was 40 mm Hg for patients in the target prescribed group, and 36 mm Hg for patients in the supplemental fluid group. Subcutaneous oxygen levels less than 45 mm Hg indicate tissue hypoxia, she said. The study was funded by the National Institutes of Health.

SAN DIEGO — Although fluid intake can be safely increased in nursing home residents who have, or are at risk for, pressure ulcers and do not routinely ingest the prescribed amount of fluid, levels of subcutaneous oxygen may remain low, results from a multicenter study showed.

“In the nursing home population, hydration is a serious issue,” Nancy A. Stotts, R.N., Ed.D., said at the annual meeting of the Wound Healing Society.

Researchers recorded fluid intake for 5 days in 64 residents of five nursing homes in Northern California. The residents were then randomized to receive, for 5 days, the target amount of fluid prescribed by their physician or the target amount plus 10 mL/kg of body weight, said Dr. Stotts, professor of nursing at the University of California, San Francisco.

Subcutaneous oxygen levels were assessed for 3 days during treatment. The mean age of patients was 79 years. The mean baseline daily fluid intake was 1,374 cc for the group who received prescribed fluid, and 1,707 cc for those who received extra fluid. After treatment, the mean daily fluid intake increased significantly for both groups: to 1,787 cc for the group who received prescribed fluid, and to 2,380 cc for those who received the extra fluid.

The mean level of subcutaneous oxygen, however, was 40 mm Hg for patients in the target prescribed group, and 36 mm Hg for patients in the supplemental fluid group. Subcutaneous oxygen levels less than 45 mm Hg indicate tissue hypoxia, she said. The study was funded by the National Institutes of Health.

High-voltage, pulsed electrical stimulation is an effective adjunct to multidisciplinary attempts at limb salvage in diabetic patients with complex lower extremity wounds, results from a small study demonstrated.

Of 45 wounds in 30 patients, 78% of the wounds healed in a mean of 14 weeks using the electrical stimulation system, Dr. Jeremy J. Burdge reported at the annual meeting of the Wound Healing Society. Dr. Burdge, a plastic and reconstructive surgeon who practices in Columbus, Ohio, and his associates evaluated the efficacy of high-voltage electrical stimulation in patients who failed to improve despite multidisciplinary treatment approaches. More than half (57%) of the patients in the study were men; their mean age was 66 years. The mean age of wounds was 25 weeks, and the mean surface area was 7.8 cm

Dr. Burdge had no conflicts to disclose.

—Doug Brunk

High-voltage, pulsed electrical stimulation is an effective adjunct to multidisciplinary attempts at limb salvage in diabetic patients with complex lower extremity wounds, results from a small study demonstrated.

Of 45 wounds in 30 patients, 78% of the wounds healed in a mean of 14 weeks using the electrical stimulation system, Dr. Jeremy J. Burdge reported at the annual meeting of the Wound Healing Society. Dr. Burdge, a plastic and reconstructive surgeon who practices in Columbus, Ohio, and his associates evaluated the efficacy of high-voltage electrical stimulation in patients who failed to improve despite multidisciplinary treatment approaches. More than half (57%) of the patients in the study were men; their mean age was 66 years. The mean age of wounds was 25 weeks, and the mean surface area was 7.8 cm

Dr. Burdge had no conflicts to disclose.

—Doug Brunk

High-voltage, pulsed electrical stimulation is an effective adjunct to multidisciplinary attempts at limb salvage in diabetic patients with complex lower extremity wounds, results from a small study demonstrated.

Of 45 wounds in 30 patients, 78% of the wounds healed in a mean of 14 weeks using the electrical stimulation system, Dr. Jeremy J. Burdge reported at the annual meeting of the Wound Healing Society. Dr. Burdge, a plastic and reconstructive surgeon who practices in Columbus, Ohio, and his associates evaluated the efficacy of high-voltage electrical stimulation in patients who failed to improve despite multidisciplinary treatment approaches. More than half (57%) of the patients in the study were men; their mean age was 66 years. The mean age of wounds was 25 weeks, and the mean surface area was 7.8 cm

Dr. Burdge had no conflicts to disclose.

—Doug Brunk