Bisphosphonates May Reduce Breast Cancer Risk

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Bisphosphonates May Reduce Breast Cancer Risk

SAN ANTONIO — Two differently designed studies found a nearly identical, roughly 30% reduction in the risk of breast cancer in postmenopausal women who took bisphosphonates to prevent or remediate bone loss.

The results of a retrospective analysis of data from the Women's Health Initiative (WHI) in the United States and a case-control study conducted in Israel were presented at the annual San Antonio Breast Cancer Symposium.

In both studies, cancer incidence was sharply lower among women prescribed bisphosphonates for low bone mineral density, suggesting that the impact of these agents may extend beyond bone.

In the 151,592-patient database for the WHI, breast cancer development was explored only after controlling for baseline bone mineral density, since women at risk for osteoporosis are known to be at lower risk for breast cancer, likely due to a lower lifetime exposure to estrogen.

Following that statistical adjustment, researchers found that only 64 of 2,216 bisphosphonate users developed breast cancer after a mean 8 years of follow-up, and that 50 of the cancers were estrogen receptor positive.

This represents a 32% lower incidence of breast cancer than was seen among non–bisphosphonate users, reported Dr. Rowan Chlebowski, a medical oncologist at the Harbor-University of California, Los Angeles Medical Center.

“This is a cohort study, not a definitive randomized, controlled trial, but I think it provides a strong signal,” said Dr. Chlebowski during a press conference preceding his podium presentation. “Oral bisphosphonate use may directly inhibit breast cancer incidence.”

No advantage was seen with respect to ductal carcinoma in situ (DCIS) in women taking bisphosphonates. Indeed, women taking bisphosphonates were slightly more likely to develop DCIS. This perhaps implies that the effects of bisphosphonates occur later in the development of breast cancer, Dr. Chlebowski said.

In Israel, women with breast cancer who reported taking bisphosphonates for at least a year prior to their diagnosis were matched to demographically similar women who were not taking bisphosphonates and without cancer. (Controls were selected by age, neighborhood, and ethnicity.)

To ensure against recall bias, researchers used prescription records to confirm a prediagnosis history of bisphosphonate use, said Dr. Gad Rennert, chairman of community medicine and epidemiology at the Clalit National Cancer Control Center in Haifa, Israel.

Among the 4,575 subjects, those who took bisphosphonates for at least a year were 34% less likely to be diagnosed with breast cancer.

Risk reduction remained significant at 29% after controlling for other risk factors for breast cancer, including age, ethnicity, family history, fruit and vegetable intake, exercise, body mass index, pregnancy history, and use of calcium supplements and hormone replacement therapy.

“The tumors we saw were more commonly estrogen receptor positive, and more precisely, strongly estrogen receptor positive,” Dr. Rennert said during his podium presentation. “They were more commonly well differentiated.”

Both estrogen receptor positivity and cell differentiation are associated with response to treatment and a better prognosis, he noted.

No effect on breast cancer risk was seen in women who took bisphosphonates for less than a year, but after 1 year, the risk was reduced at a fairly steady rate. “Five years of use was not dramatically better than 4 years of use,” he said. This finding corresponds with the drugs' pharmacokinetic profile, characterized by a slow and steady cumulative effect on bone that stabilizes after a period of time.

“We are seeing an association here. It's a very strong and robust association,” Dr. Rennert said.

Initially, a hint of cancer protection arose in small studies comparing breast cancer patients receiving bisphosphonates for cancer- and treatment-related bone loss to those who did not receive the drugs. The evidence seemed to show that those receiving the bone-protecting drugs also developed fewer new cancers in their contralateral breasts.

Possible biologic explanations may lie in the ability of bisphosphonates to reduce angiogenesis and stimulate immune cells responsible for tumor cell detection, Dr. Chlebowski said in an interview.

Dr. Theresa Guise, professor of medicine and oncology at Indiana University, Indianapolis, said the studies may hold “very important implications for a large population of patients.”

The possibility that a “simple oral drug” could prevent both osteoporosis and breast cancer represents a “step forward in the prevention of … common health problems of women today,” Dr. Guise commented during a discussion of the papers at a press conference.

Bisphosphonates, which can be taken either orally or in an intravenous infusion, are prescribed to about 30 million patients each year.

Disclosures: Dr. Chlebowski disclosed that he has been a consultant for, or served on speakers bureaus for AstraZeneca, Novartis, Pfizer, Amgen, and Eli Lilly. Dr. Rennert disclosed no relevant financial relationships. Dr. Guise said she has been a consultant for or served on speakers bureaus for Amgen, Novartis, Eli Lilly, and Roche Pharmaceuticals.

 

 

A related video is at www.youtube.com/InternalMedicineNews

“Oral bisphosphonate use may directly inhibit breast cancer incidence,” said Dr. Rowan Chlebowski.

Source Bruce Jancin/Elsevier Global Medical News

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SAN ANTONIO — Two differently designed studies found a nearly identical, roughly 30% reduction in the risk of breast cancer in postmenopausal women who took bisphosphonates to prevent or remediate bone loss.

The results of a retrospective analysis of data from the Women's Health Initiative (WHI) in the United States and a case-control study conducted in Israel were presented at the annual San Antonio Breast Cancer Symposium.

In both studies, cancer incidence was sharply lower among women prescribed bisphosphonates for low bone mineral density, suggesting that the impact of these agents may extend beyond bone.

In the 151,592-patient database for the WHI, breast cancer development was explored only after controlling for baseline bone mineral density, since women at risk for osteoporosis are known to be at lower risk for breast cancer, likely due to a lower lifetime exposure to estrogen.

Following that statistical adjustment, researchers found that only 64 of 2,216 bisphosphonate users developed breast cancer after a mean 8 years of follow-up, and that 50 of the cancers were estrogen receptor positive.

This represents a 32% lower incidence of breast cancer than was seen among non–bisphosphonate users, reported Dr. Rowan Chlebowski, a medical oncologist at the Harbor-University of California, Los Angeles Medical Center.

“This is a cohort study, not a definitive randomized, controlled trial, but I think it provides a strong signal,” said Dr. Chlebowski during a press conference preceding his podium presentation. “Oral bisphosphonate use may directly inhibit breast cancer incidence.”

No advantage was seen with respect to ductal carcinoma in situ (DCIS) in women taking bisphosphonates. Indeed, women taking bisphosphonates were slightly more likely to develop DCIS. This perhaps implies that the effects of bisphosphonates occur later in the development of breast cancer, Dr. Chlebowski said.

In Israel, women with breast cancer who reported taking bisphosphonates for at least a year prior to their diagnosis were matched to demographically similar women who were not taking bisphosphonates and without cancer. (Controls were selected by age, neighborhood, and ethnicity.)

To ensure against recall bias, researchers used prescription records to confirm a prediagnosis history of bisphosphonate use, said Dr. Gad Rennert, chairman of community medicine and epidemiology at the Clalit National Cancer Control Center in Haifa, Israel.

Among the 4,575 subjects, those who took bisphosphonates for at least a year were 34% less likely to be diagnosed with breast cancer.

Risk reduction remained significant at 29% after controlling for other risk factors for breast cancer, including age, ethnicity, family history, fruit and vegetable intake, exercise, body mass index, pregnancy history, and use of calcium supplements and hormone replacement therapy.

“The tumors we saw were more commonly estrogen receptor positive, and more precisely, strongly estrogen receptor positive,” Dr. Rennert said during his podium presentation. “They were more commonly well differentiated.”

Both estrogen receptor positivity and cell differentiation are associated with response to treatment and a better prognosis, he noted.

No effect on breast cancer risk was seen in women who took bisphosphonates for less than a year, but after 1 year, the risk was reduced at a fairly steady rate. “Five years of use was not dramatically better than 4 years of use,” he said. This finding corresponds with the drugs' pharmacokinetic profile, characterized by a slow and steady cumulative effect on bone that stabilizes after a period of time.

“We are seeing an association here. It's a very strong and robust association,” Dr. Rennert said.

Initially, a hint of cancer protection arose in small studies comparing breast cancer patients receiving bisphosphonates for cancer- and treatment-related bone loss to those who did not receive the drugs. The evidence seemed to show that those receiving the bone-protecting drugs also developed fewer new cancers in their contralateral breasts.

Possible biologic explanations may lie in the ability of bisphosphonates to reduce angiogenesis and stimulate immune cells responsible for tumor cell detection, Dr. Chlebowski said in an interview.

Dr. Theresa Guise, professor of medicine and oncology at Indiana University, Indianapolis, said the studies may hold “very important implications for a large population of patients.”

The possibility that a “simple oral drug” could prevent both osteoporosis and breast cancer represents a “step forward in the prevention of … common health problems of women today,” Dr. Guise commented during a discussion of the papers at a press conference.

Bisphosphonates, which can be taken either orally or in an intravenous infusion, are prescribed to about 30 million patients each year.

Disclosures: Dr. Chlebowski disclosed that he has been a consultant for, or served on speakers bureaus for AstraZeneca, Novartis, Pfizer, Amgen, and Eli Lilly. Dr. Rennert disclosed no relevant financial relationships. Dr. Guise said she has been a consultant for or served on speakers bureaus for Amgen, Novartis, Eli Lilly, and Roche Pharmaceuticals.

 

 

A related video is at www.youtube.com/InternalMedicineNews

“Oral bisphosphonate use may directly inhibit breast cancer incidence,” said Dr. Rowan Chlebowski.

Source Bruce Jancin/Elsevier Global Medical News

SAN ANTONIO — Two differently designed studies found a nearly identical, roughly 30% reduction in the risk of breast cancer in postmenopausal women who took bisphosphonates to prevent or remediate bone loss.

The results of a retrospective analysis of data from the Women's Health Initiative (WHI) in the United States and a case-control study conducted in Israel were presented at the annual San Antonio Breast Cancer Symposium.

In both studies, cancer incidence was sharply lower among women prescribed bisphosphonates for low bone mineral density, suggesting that the impact of these agents may extend beyond bone.

In the 151,592-patient database for the WHI, breast cancer development was explored only after controlling for baseline bone mineral density, since women at risk for osteoporosis are known to be at lower risk for breast cancer, likely due to a lower lifetime exposure to estrogen.

Following that statistical adjustment, researchers found that only 64 of 2,216 bisphosphonate users developed breast cancer after a mean 8 years of follow-up, and that 50 of the cancers were estrogen receptor positive.

This represents a 32% lower incidence of breast cancer than was seen among non–bisphosphonate users, reported Dr. Rowan Chlebowski, a medical oncologist at the Harbor-University of California, Los Angeles Medical Center.

“This is a cohort study, not a definitive randomized, controlled trial, but I think it provides a strong signal,” said Dr. Chlebowski during a press conference preceding his podium presentation. “Oral bisphosphonate use may directly inhibit breast cancer incidence.”

No advantage was seen with respect to ductal carcinoma in situ (DCIS) in women taking bisphosphonates. Indeed, women taking bisphosphonates were slightly more likely to develop DCIS. This perhaps implies that the effects of bisphosphonates occur later in the development of breast cancer, Dr. Chlebowski said.

In Israel, women with breast cancer who reported taking bisphosphonates for at least a year prior to their diagnosis were matched to demographically similar women who were not taking bisphosphonates and without cancer. (Controls were selected by age, neighborhood, and ethnicity.)

To ensure against recall bias, researchers used prescription records to confirm a prediagnosis history of bisphosphonate use, said Dr. Gad Rennert, chairman of community medicine and epidemiology at the Clalit National Cancer Control Center in Haifa, Israel.

Among the 4,575 subjects, those who took bisphosphonates for at least a year were 34% less likely to be diagnosed with breast cancer.

Risk reduction remained significant at 29% after controlling for other risk factors for breast cancer, including age, ethnicity, family history, fruit and vegetable intake, exercise, body mass index, pregnancy history, and use of calcium supplements and hormone replacement therapy.

“The tumors we saw were more commonly estrogen receptor positive, and more precisely, strongly estrogen receptor positive,” Dr. Rennert said during his podium presentation. “They were more commonly well differentiated.”

Both estrogen receptor positivity and cell differentiation are associated with response to treatment and a better prognosis, he noted.

No effect on breast cancer risk was seen in women who took bisphosphonates for less than a year, but after 1 year, the risk was reduced at a fairly steady rate. “Five years of use was not dramatically better than 4 years of use,” he said. This finding corresponds with the drugs' pharmacokinetic profile, characterized by a slow and steady cumulative effect on bone that stabilizes after a period of time.

“We are seeing an association here. It's a very strong and robust association,” Dr. Rennert said.

Initially, a hint of cancer protection arose in small studies comparing breast cancer patients receiving bisphosphonates for cancer- and treatment-related bone loss to those who did not receive the drugs. The evidence seemed to show that those receiving the bone-protecting drugs also developed fewer new cancers in their contralateral breasts.

Possible biologic explanations may lie in the ability of bisphosphonates to reduce angiogenesis and stimulate immune cells responsible for tumor cell detection, Dr. Chlebowski said in an interview.

Dr. Theresa Guise, professor of medicine and oncology at Indiana University, Indianapolis, said the studies may hold “very important implications for a large population of patients.”

The possibility that a “simple oral drug” could prevent both osteoporosis and breast cancer represents a “step forward in the prevention of … common health problems of women today,” Dr. Guise commented during a discussion of the papers at a press conference.

Bisphosphonates, which can be taken either orally or in an intravenous infusion, are prescribed to about 30 million patients each year.

Disclosures: Dr. Chlebowski disclosed that he has been a consultant for, or served on speakers bureaus for AstraZeneca, Novartis, Pfizer, Amgen, and Eli Lilly. Dr. Rennert disclosed no relevant financial relationships. Dr. Guise said she has been a consultant for or served on speakers bureaus for Amgen, Novartis, Eli Lilly, and Roche Pharmaceuticals.

 

 

A related video is at www.youtube.com/InternalMedicineNews

“Oral bisphosphonate use may directly inhibit breast cancer incidence,” said Dr. Rowan Chlebowski.

Source Bruce Jancin/Elsevier Global Medical News

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Sharp Rise Seen in Prophylactic Contralateral Mastectomy

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Sharp Rise Seen in Prophylactic Contralateral Mastectomy

SAN ANTONIO — Breast cancer patients undergoing prophylactic contralateral mastectomy are generally not at high risk for contralateral breast cancer, and may be influenced by anxiety or imaging studies that may not have clinical relevance, based on a study presented at the San Antonio Breast Cancer Symposium.

Rates of prophylactic contralateral mastectomy have increased “dramatically” among women with all stages of breast cancer in the United States in recent years, said Dr. Tari A. King, a breast cancer surgeon at Memorial Sloan-Kettering Cancer Center in New York City.

From January 1997 to December 2005, for example, rates of the procedure increased from 7% to 24% of women who underwent mastectomy at her institution, she said in an interview following her presentation.

Dr. King and her associates sought to learn whether the increase in prophylactic mastectomy could be attributed to better awareness of risk factors for contralateral recurrence or treatment factors related to the index lesion.

A total of 2,965 women underwent mastectomy for stage 0-III unilateral breast cancer during the study period, 407 of whom (13.7%) opted to have a prophylactic mastectomy of the contralateral breast within 12 months. The majority (367) had the contralateral procedure immediately following breast cancer surgery.

Women who opted for prophylactic contralateral mastectomy were younger than those who did not undergo the added surgery (mean age, 45 vs. 54 years) and more likely to be white (93% vs. 7%).

The P values for both characteristics were highly significant.

Equally significant was that women choosing contralateral prophylactic mastectomy were more likely to have a family history of breast cancer (68% vs. 32%). Dr. King noted, however, that 43% of patients opting for additional surgery had no first-degree relatives with breast cancer. Almost half (49%) had two first-degree relatives with breast cancer, and just 8% had two or more first-degree relatives with the disease.

Just 13% of those who underwent prophylactic surgery were considered “high risk” because they were BRCA gene carriers (37 patients) or had undergone prior mantle radiation for Hodgkin's disease (15 patients).

Index cancer pathology revealed only ductal carcinoma in situ in 22% of patients who opted to have their contralateral breasts removed, suggesting that they were at exceedingly low risk of a contralateral recurrence. The mean tumor size was larger among women who failed to have prophylactic surgery (2.16 cm vs. 1.53 cm), as was positive node status (57% vs. 47%); both differences were statistically significant.

Clinical management factors strongly associated with prophylactic surgery included MRI at diagnosis and an additional biopsy in the contralateral breast because of MRI results. Nearly half of women who decided on additional surgery (43%) had undergone an MRI, compared with just 16% of those who did not opt to have a prophylactic mastectomy.

The MRIs led to an additional contralateral or bilateral biopsy in 29% of women who chose added surgery, compared with just 4% in the group who did not (P less than .0001). However, many of the women with MRI findings never had a biopsy to confirm whether a malignancy was present in the contralateral breast, instead deciding preemptively on a contralateral prophylactic mastectomy.

Breast conservation surgery was attempted in more women in the prophylactic mastectomy group (28%, compared with 16%; P less than .0001). The same women were more likely to undergo breast reconstruction, 87% vs. 51% (P less than .0001), suggesting that some women may have chosen the added surgery in order to achieve cosmetic symmetry.

After a median follow-up of 6 years, contralateral breast cancer developed in 12 (0.4%) women who did not undergo contralateral prophylactic mastectomies.

Disclosures: Neither Dr. King nor any of her coinvestigators reported any relevant financial disclosures.

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SAN ANTONIO — Breast cancer patients undergoing prophylactic contralateral mastectomy are generally not at high risk for contralateral breast cancer, and may be influenced by anxiety or imaging studies that may not have clinical relevance, based on a study presented at the San Antonio Breast Cancer Symposium.

Rates of prophylactic contralateral mastectomy have increased “dramatically” among women with all stages of breast cancer in the United States in recent years, said Dr. Tari A. King, a breast cancer surgeon at Memorial Sloan-Kettering Cancer Center in New York City.

From January 1997 to December 2005, for example, rates of the procedure increased from 7% to 24% of women who underwent mastectomy at her institution, she said in an interview following her presentation.

Dr. King and her associates sought to learn whether the increase in prophylactic mastectomy could be attributed to better awareness of risk factors for contralateral recurrence or treatment factors related to the index lesion.

A total of 2,965 women underwent mastectomy for stage 0-III unilateral breast cancer during the study period, 407 of whom (13.7%) opted to have a prophylactic mastectomy of the contralateral breast within 12 months. The majority (367) had the contralateral procedure immediately following breast cancer surgery.

Women who opted for prophylactic contralateral mastectomy were younger than those who did not undergo the added surgery (mean age, 45 vs. 54 years) and more likely to be white (93% vs. 7%).

The P values for both characteristics were highly significant.

Equally significant was that women choosing contralateral prophylactic mastectomy were more likely to have a family history of breast cancer (68% vs. 32%). Dr. King noted, however, that 43% of patients opting for additional surgery had no first-degree relatives with breast cancer. Almost half (49%) had two first-degree relatives with breast cancer, and just 8% had two or more first-degree relatives with the disease.

Just 13% of those who underwent prophylactic surgery were considered “high risk” because they were BRCA gene carriers (37 patients) or had undergone prior mantle radiation for Hodgkin's disease (15 patients).

Index cancer pathology revealed only ductal carcinoma in situ in 22% of patients who opted to have their contralateral breasts removed, suggesting that they were at exceedingly low risk of a contralateral recurrence. The mean tumor size was larger among women who failed to have prophylactic surgery (2.16 cm vs. 1.53 cm), as was positive node status (57% vs. 47%); both differences were statistically significant.

Clinical management factors strongly associated with prophylactic surgery included MRI at diagnosis and an additional biopsy in the contralateral breast because of MRI results. Nearly half of women who decided on additional surgery (43%) had undergone an MRI, compared with just 16% of those who did not opt to have a prophylactic mastectomy.

The MRIs led to an additional contralateral or bilateral biopsy in 29% of women who chose added surgery, compared with just 4% in the group who did not (P less than .0001). However, many of the women with MRI findings never had a biopsy to confirm whether a malignancy was present in the contralateral breast, instead deciding preemptively on a contralateral prophylactic mastectomy.

Breast conservation surgery was attempted in more women in the prophylactic mastectomy group (28%, compared with 16%; P less than .0001). The same women were more likely to undergo breast reconstruction, 87% vs. 51% (P less than .0001), suggesting that some women may have chosen the added surgery in order to achieve cosmetic symmetry.

After a median follow-up of 6 years, contralateral breast cancer developed in 12 (0.4%) women who did not undergo contralateral prophylactic mastectomies.

Disclosures: Neither Dr. King nor any of her coinvestigators reported any relevant financial disclosures.

SAN ANTONIO — Breast cancer patients undergoing prophylactic contralateral mastectomy are generally not at high risk for contralateral breast cancer, and may be influenced by anxiety or imaging studies that may not have clinical relevance, based on a study presented at the San Antonio Breast Cancer Symposium.

Rates of prophylactic contralateral mastectomy have increased “dramatically” among women with all stages of breast cancer in the United States in recent years, said Dr. Tari A. King, a breast cancer surgeon at Memorial Sloan-Kettering Cancer Center in New York City.

From January 1997 to December 2005, for example, rates of the procedure increased from 7% to 24% of women who underwent mastectomy at her institution, she said in an interview following her presentation.

Dr. King and her associates sought to learn whether the increase in prophylactic mastectomy could be attributed to better awareness of risk factors for contralateral recurrence or treatment factors related to the index lesion.

A total of 2,965 women underwent mastectomy for stage 0-III unilateral breast cancer during the study period, 407 of whom (13.7%) opted to have a prophylactic mastectomy of the contralateral breast within 12 months. The majority (367) had the contralateral procedure immediately following breast cancer surgery.

Women who opted for prophylactic contralateral mastectomy were younger than those who did not undergo the added surgery (mean age, 45 vs. 54 years) and more likely to be white (93% vs. 7%).

The P values for both characteristics were highly significant.

Equally significant was that women choosing contralateral prophylactic mastectomy were more likely to have a family history of breast cancer (68% vs. 32%). Dr. King noted, however, that 43% of patients opting for additional surgery had no first-degree relatives with breast cancer. Almost half (49%) had two first-degree relatives with breast cancer, and just 8% had two or more first-degree relatives with the disease.

Just 13% of those who underwent prophylactic surgery were considered “high risk” because they were BRCA gene carriers (37 patients) or had undergone prior mantle radiation for Hodgkin's disease (15 patients).

Index cancer pathology revealed only ductal carcinoma in situ in 22% of patients who opted to have their contralateral breasts removed, suggesting that they were at exceedingly low risk of a contralateral recurrence. The mean tumor size was larger among women who failed to have prophylactic surgery (2.16 cm vs. 1.53 cm), as was positive node status (57% vs. 47%); both differences were statistically significant.

Clinical management factors strongly associated with prophylactic surgery included MRI at diagnosis and an additional biopsy in the contralateral breast because of MRI results. Nearly half of women who decided on additional surgery (43%) had undergone an MRI, compared with just 16% of those who did not opt to have a prophylactic mastectomy.

The MRIs led to an additional contralateral or bilateral biopsy in 29% of women who chose added surgery, compared with just 4% in the group who did not (P less than .0001). However, many of the women with MRI findings never had a biopsy to confirm whether a malignancy was present in the contralateral breast, instead deciding preemptively on a contralateral prophylactic mastectomy.

Breast conservation surgery was attempted in more women in the prophylactic mastectomy group (28%, compared with 16%; P less than .0001). The same women were more likely to undergo breast reconstruction, 87% vs. 51% (P less than .0001), suggesting that some women may have chosen the added surgery in order to achieve cosmetic symmetry.

After a median follow-up of 6 years, contralateral breast cancer developed in 12 (0.4%) women who did not undergo contralateral prophylactic mastectomies.

Disclosures: Neither Dr. King nor any of her coinvestigators reported any relevant financial disclosures.

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Anti-Estrogen Therapy May Cut Lung Ca Deaths

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SAN ANTONIO — Women treated with anti-estrogen therapy for breast cancer appeared to have a reduced risk of dying later from lung cancer in a Swiss registry study, suggesting that the agents may be protective, Dr. Elisabetta Rapiti reported at the annual San Antonio Breast Cancer Symposium.

In a national registry of 6,655 breast cancer patients who were followed for up to 27 years, 40 women subsequently developed lung cancer. Of those, 12 had received anti-estrogen therapy and 28 had not, reported Dr. Rapiti, a medical researcher at the University of Geneva.

In comparison to the general population, the age-adjusted standardized mortality ratio for lung cancer was 0.13 (95% confidence interval, 0.02–0.47) among women who had received anti-estrogen therapy (P value of less than .001).

Breast cancer survivors who did not receive anti-estrogens had a standardized lung cancer mortality rate of 0.76 (95% CI, 0.43–1.23), a rate not significantly different from that of other women.

Calculated another way, the lung cancer mortality rate was 9.23 per 100,000 in the group that received anti-estrogen therapy, versus 44.97 per 100,000 for those who did not.

The idea that anti-estrogens might protect against lung cancer emerged from a post-hoc analysis of data from the Women's Health Initiative, since women taking combined estrogen-progestin hormonal therapy were found to have died from lung cancer at a significantly higher rate over 7.5 years of follow-up (Lancet 2009;347:1243–51).

“We thought if this [combined hormonal therapy] increased lung cancer mortality, maybe the anti-estrogens would be associated with a decreased risk of lung cancer mortality,” Dr. Rapiti said.

She and her associates examined Geneva Cancer Registry breast cancer cases diagnosed between 1980 and 2003, determining that 46% of the cases included treatment with an anti-estrogen therapy, mostly tamoxifen. Patient outcomes were tracked until the end of 2007.

Women who received anti-estrogen therapy were slightly older and more likely to be post menopause than those who did not get the therapy, and had a lower income.

Smoking histories were similar between users and nonusers and the general population, with nearly 30% reporting current smoking. About 15% of breast cancer patients were ex-smokers, again, similar to the general population in Switzerland.

The principal investigator of the WHI lung cancer mortality study, Dr. Rowan Chlebowski, commented on Dr. Rapiti's study during the question-and-answer period following her presentation. In the WHI study, most of the mortality difference was seen in patients who had non–small cell lung cancer.

An update to the WHI findings will be coming soon, tracking 4 more years of follow-up in women after they had ceased taking combination hormonal therapy, said Dr. Chlebowski of the Harbor–University of California, Los Angeles Medical Center in Torrance.

Differences in lung cancer histology have not yet been analyzed in the Geneva Cancer Registry, Dr. Rapiti noted, although that analysis is planned. Although the study was observational and retrospective, the results “further support the hypothesis that estrogen plays a role in prognosis of lung cancer.”

Dr. Rapiti reported no relevant financial disclosures in connection with her study.

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SAN ANTONIO — Women treated with anti-estrogen therapy for breast cancer appeared to have a reduced risk of dying later from lung cancer in a Swiss registry study, suggesting that the agents may be protective, Dr. Elisabetta Rapiti reported at the annual San Antonio Breast Cancer Symposium.

In a national registry of 6,655 breast cancer patients who were followed for up to 27 years, 40 women subsequently developed lung cancer. Of those, 12 had received anti-estrogen therapy and 28 had not, reported Dr. Rapiti, a medical researcher at the University of Geneva.

In comparison to the general population, the age-adjusted standardized mortality ratio for lung cancer was 0.13 (95% confidence interval, 0.02–0.47) among women who had received anti-estrogen therapy (P value of less than .001).

Breast cancer survivors who did not receive anti-estrogens had a standardized lung cancer mortality rate of 0.76 (95% CI, 0.43–1.23), a rate not significantly different from that of other women.

Calculated another way, the lung cancer mortality rate was 9.23 per 100,000 in the group that received anti-estrogen therapy, versus 44.97 per 100,000 for those who did not.

The idea that anti-estrogens might protect against lung cancer emerged from a post-hoc analysis of data from the Women's Health Initiative, since women taking combined estrogen-progestin hormonal therapy were found to have died from lung cancer at a significantly higher rate over 7.5 years of follow-up (Lancet 2009;347:1243–51).

“We thought if this [combined hormonal therapy] increased lung cancer mortality, maybe the anti-estrogens would be associated with a decreased risk of lung cancer mortality,” Dr. Rapiti said.

She and her associates examined Geneva Cancer Registry breast cancer cases diagnosed between 1980 and 2003, determining that 46% of the cases included treatment with an anti-estrogen therapy, mostly tamoxifen. Patient outcomes were tracked until the end of 2007.

Women who received anti-estrogen therapy were slightly older and more likely to be post menopause than those who did not get the therapy, and had a lower income.

Smoking histories were similar between users and nonusers and the general population, with nearly 30% reporting current smoking. About 15% of breast cancer patients were ex-smokers, again, similar to the general population in Switzerland.

The principal investigator of the WHI lung cancer mortality study, Dr. Rowan Chlebowski, commented on Dr. Rapiti's study during the question-and-answer period following her presentation. In the WHI study, most of the mortality difference was seen in patients who had non–small cell lung cancer.

An update to the WHI findings will be coming soon, tracking 4 more years of follow-up in women after they had ceased taking combination hormonal therapy, said Dr. Chlebowski of the Harbor–University of California, Los Angeles Medical Center in Torrance.

Differences in lung cancer histology have not yet been analyzed in the Geneva Cancer Registry, Dr. Rapiti noted, although that analysis is planned. Although the study was observational and retrospective, the results “further support the hypothesis that estrogen plays a role in prognosis of lung cancer.”

Dr. Rapiti reported no relevant financial disclosures in connection with her study.

SAN ANTONIO — Women treated with anti-estrogen therapy for breast cancer appeared to have a reduced risk of dying later from lung cancer in a Swiss registry study, suggesting that the agents may be protective, Dr. Elisabetta Rapiti reported at the annual San Antonio Breast Cancer Symposium.

In a national registry of 6,655 breast cancer patients who were followed for up to 27 years, 40 women subsequently developed lung cancer. Of those, 12 had received anti-estrogen therapy and 28 had not, reported Dr. Rapiti, a medical researcher at the University of Geneva.

In comparison to the general population, the age-adjusted standardized mortality ratio for lung cancer was 0.13 (95% confidence interval, 0.02–0.47) among women who had received anti-estrogen therapy (P value of less than .001).

Breast cancer survivors who did not receive anti-estrogens had a standardized lung cancer mortality rate of 0.76 (95% CI, 0.43–1.23), a rate not significantly different from that of other women.

Calculated another way, the lung cancer mortality rate was 9.23 per 100,000 in the group that received anti-estrogen therapy, versus 44.97 per 100,000 for those who did not.

The idea that anti-estrogens might protect against lung cancer emerged from a post-hoc analysis of data from the Women's Health Initiative, since women taking combined estrogen-progestin hormonal therapy were found to have died from lung cancer at a significantly higher rate over 7.5 years of follow-up (Lancet 2009;347:1243–51).

“We thought if this [combined hormonal therapy] increased lung cancer mortality, maybe the anti-estrogens would be associated with a decreased risk of lung cancer mortality,” Dr. Rapiti said.

She and her associates examined Geneva Cancer Registry breast cancer cases diagnosed between 1980 and 2003, determining that 46% of the cases included treatment with an anti-estrogen therapy, mostly tamoxifen. Patient outcomes were tracked until the end of 2007.

Women who received anti-estrogen therapy were slightly older and more likely to be post menopause than those who did not get the therapy, and had a lower income.

Smoking histories were similar between users and nonusers and the general population, with nearly 30% reporting current smoking. About 15% of breast cancer patients were ex-smokers, again, similar to the general population in Switzerland.

The principal investigator of the WHI lung cancer mortality study, Dr. Rowan Chlebowski, commented on Dr. Rapiti's study during the question-and-answer period following her presentation. In the WHI study, most of the mortality difference was seen in patients who had non–small cell lung cancer.

An update to the WHI findings will be coming soon, tracking 4 more years of follow-up in women after they had ceased taking combination hormonal therapy, said Dr. Chlebowski of the Harbor–University of California, Los Angeles Medical Center in Torrance.

Differences in lung cancer histology have not yet been analyzed in the Geneva Cancer Registry, Dr. Rapiti noted, although that analysis is planned. Although the study was observational and retrospective, the results “further support the hypothesis that estrogen plays a role in prognosis of lung cancer.”

Dr. Rapiti reported no relevant financial disclosures in connection with her study.

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Infants Benefit From Maternal Flu Vaccination

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When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy. The efficacy of vaccination was determined by comparing flulike respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flulike illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women. Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean of 3,186 g, compared with a mean of 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to give birth prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When potential confounders were controlled for, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference. The study results remained significant even after maternal age, race, insurance status, and prepregnancy maternal weight were controlled for.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy on the health of their infants from birth to 1 year of life.

Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants aged 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician at Yale, New Haven, Conn.

Protection appeared greatest (an 85% reduction in hospitalizations) among the most vulnerable infants, those 6 months or younger. Influenza vaccine is not recommended for children younger than age 6 months. When unvaccinated mothers were asked why they did not receive the flu shot during pregnancy, as recommended by the American College of Obstetricians and Gynecologists, most said they were never offered the vaccine, Dr. Vázquez said.

Findings from previous studies suggest that a “cultural change” may be necessary for obstetricians to become more involved in influenza vaccination campaigns, said Dr. William Schaffner, moderator of the press conference and a preventive medicine specialist from Vanderbilt University Medical Center in Nashville, Tenn.

While pediatricians consider vaccination a key part of their practices, obstetricians' offices aren't set up to order, store, and deliver vaccines, he said. However, evidence presented at the meeting of a “powerfully protective” effect on infants when their mothers are vaccinated during pregnancy may help to spur obstetricians to take a more active role in influenza prevention efforts, Dr. Schaffner predicted.

Dr. Steinhoff reported that he has received research grants from vaccine manufacturers Wyeth and Sarnoff-Aventis.

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When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy. The efficacy of vaccination was determined by comparing flulike respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flulike illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women. Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean of 3,186 g, compared with a mean of 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to give birth prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When potential confounders were controlled for, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference. The study results remained significant even after maternal age, race, insurance status, and prepregnancy maternal weight were controlled for.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy on the health of their infants from birth to 1 year of life.

Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants aged 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician at Yale, New Haven, Conn.

Protection appeared greatest (an 85% reduction in hospitalizations) among the most vulnerable infants, those 6 months or younger. Influenza vaccine is not recommended for children younger than age 6 months. When unvaccinated mothers were asked why they did not receive the flu shot during pregnancy, as recommended by the American College of Obstetricians and Gynecologists, most said they were never offered the vaccine, Dr. Vázquez said.

Findings from previous studies suggest that a “cultural change” may be necessary for obstetricians to become more involved in influenza vaccination campaigns, said Dr. William Schaffner, moderator of the press conference and a preventive medicine specialist from Vanderbilt University Medical Center in Nashville, Tenn.

While pediatricians consider vaccination a key part of their practices, obstetricians' offices aren't set up to order, store, and deliver vaccines, he said. However, evidence presented at the meeting of a “powerfully protective” effect on infants when their mothers are vaccinated during pregnancy may help to spur obstetricians to take a more active role in influenza prevention efforts, Dr. Schaffner predicted.

Dr. Steinhoff reported that he has received research grants from vaccine manufacturers Wyeth and Sarnoff-Aventis.

When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy. The efficacy of vaccination was determined by comparing flulike respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flulike illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women. Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean of 3,186 g, compared with a mean of 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to give birth prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When potential confounders were controlled for, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference. The study results remained significant even after maternal age, race, insurance status, and prepregnancy maternal weight were controlled for.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy on the health of their infants from birth to 1 year of life.

Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants aged 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician at Yale, New Haven, Conn.

Protection appeared greatest (an 85% reduction in hospitalizations) among the most vulnerable infants, those 6 months or younger. Influenza vaccine is not recommended for children younger than age 6 months. When unvaccinated mothers were asked why they did not receive the flu shot during pregnancy, as recommended by the American College of Obstetricians and Gynecologists, most said they were never offered the vaccine, Dr. Vázquez said.

Findings from previous studies suggest that a “cultural change” may be necessary for obstetricians to become more involved in influenza vaccination campaigns, said Dr. William Schaffner, moderator of the press conference and a preventive medicine specialist from Vanderbilt University Medical Center in Nashville, Tenn.

While pediatricians consider vaccination a key part of their practices, obstetricians' offices aren't set up to order, store, and deliver vaccines, he said. However, evidence presented at the meeting of a “powerfully protective” effect on infants when their mothers are vaccinated during pregnancy may help to spur obstetricians to take a more active role in influenza prevention efforts, Dr. Schaffner predicted.

Dr. Steinhoff reported that he has received research grants from vaccine manufacturers Wyeth and Sarnoff-Aventis.

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Maternal Influenza Vaccination Benefits Baby

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Maternal Influenza Vaccination Benefits Baby

When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy.

Efficacy of vaccination was determined by comparing flu-like respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flu-like illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women.

Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean 3,186 g compared with a mean 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus, he said.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to deliver prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When controlling for potential confounders, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference.

The study results remained significant even after controlling for maternal age, race, insurance status, and prepregnancy maternal weight.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy and the health of their infants from birth to 1 year of life. Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants ages 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician.

Protection appeared greatest (an 85% reduction in hospitalization) among the most vulnerable infants, those 6 months or younger.

Dr. Steinhoff reported that he has received research grants from Wyeth and Sarnoff-Aventis, companies that manufacture vaccinations.

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When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy.

Efficacy of vaccination was determined by comparing flu-like respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flu-like illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women.

Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean 3,186 g compared with a mean 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus, he said.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to deliver prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When controlling for potential confounders, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference.

The study results remained significant even after controlling for maternal age, race, insurance status, and prepregnancy maternal weight.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy and the health of their infants from birth to 1 year of life. Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants ages 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician.

Protection appeared greatest (an 85% reduction in hospitalization) among the most vulnerable infants, those 6 months or younger.

Dr. Steinhoff reported that he has received research grants from Wyeth and Sarnoff-Aventis, companies that manufacture vaccinations.

When women receive an influenza vaccine during pregnancy, their babies benefit, according to a series of studies presented at the annual meeting of the Infectious Diseases Society of America in Philadelphia.

Three separate studies highlighted during a press conference all reached the same conclusion: that maternal vaccination enhances the well-being of newborns and infants when pregnancies coincide with influenza season.

The “Mother's Gift Study,” led by Dr. Mark C. Steinhoff of Cincinnati Children's Hospital Medical Center, tracked birth weights of infants born to 340 Bangladeshi mothers who were randomized to receive inactivated trivalent influenza (study group) or pneumococcal 23v vaccine (control) during the third trimester of pregnancy.

Efficacy of vaccination was determined by comparing flu-like respiratory illnesses with fever in the two groups over time, as the spread of the influenza virus waxed and waned.

During late 2004 and early 2005, little difference was seen in flu-like illnesses between the two groups. But during a peak period of flu infection—February 2005 to November 2005—there was a 49% reduction in such illnesses among vaccinated women.

Infants born to mothers immunized during flu season were significantly larger than those born to mothers who received the control vaccine during the same period—a mean 3,186 g compared with a mean 2,972 g for infants born to nonimmunized mothers.

The striking difference in birth weights suggests that, in addition to those who were overtly ill, many unvaccinated mothers were exposed to mild cases of influenza that may have had an effect on the nutrition delivered to the placenta, said Dr. Steinhoff.

The theory makes sense because many other mild infections, including urinary tract infections, have been known to have a similarly detrimental effect on the developing fetus, he said.

Evidence of healthier birth weights from a randomized controlled trial provide “very strong evidence that receiving the vaccination makes a difference,” said Dr. Steinhoff.

Further support for maternal seasonal influenza vaccination came from Saad B. Omer, Ph.D., of Emory University's Rollins School of Public Health in Atlanta.

He presented results of a retrospective study of health records from the Georgia Pregnancy Risk Assessment Monitoring System (PRAMS) designed to calculate the impact of maternal influenza immunization on prematurity and birth weight in a U.S. population.

A total of 6,410 births occurred between June 2004 and September 2006, with just 15% of infants born to mothers who were immunized for influenza during their pregnancies.

Immunized mothers were 70% less likely to deliver prematurely during widespread influenza activity periods, with an odds ratio of 0.3 (0.1-0.7), he said.

When controlling for potential confounders, the likelihood of delivering a baby small for gestational age (SGA) was reduced by 70% as well, Dr. Omer reported at the press conference.

The study results remained significant even after controlling for maternal age, race, insurance status, and prepregnancy maternal weight.

In a third study, Yale University researchers investigated the impact of maternal immunization during pregnancy and the health of their infants from birth to 1 year of life. Preliminary results of a matched case-control study (157 cases, 195 matched controls) found a 79% reduction in hospitalization among the infants ages 0-12 months when their mothers were vaccinated during pregnancy, reported Dr. Mariette Vázquez, a pediatrician.

Protection appeared greatest (an 85% reduction in hospitalization) among the most vulnerable infants, those 6 months or younger.

Dr. Steinhoff reported that he has received research grants from Wyeth and Sarnoff-Aventis, companies that manufacture vaccinations.

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Treat PTSD, Substance Abuse at the Same Time

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Treat PTSD, Substance Abuse at the Same Time

A revolution is brewing in the treatment of patients with co-occurring posttraumatic stress disorder and substance use, inspired by a growing body of evidence that the disorders can be successfully addressed simultaneously.

An estimated half of returning veterans and a third of civilians with PTSD have co-occurring substance abuse, while up to 42% of people in treatment for addictions have a current diagnosis of PTSD. Yet, few programs traditionally addressed both issues simultaneously.

Patients presenting with PTSD were excluded from research studies and many treatment programs if they had an ongoing substance use problem.

Barriers blocked the route to dual treatment at substance abuse clinics as well, where clinicians were reticent to address, much less treat, PTSD.

“There's been a kind of historical trepidation to deal with PTSD when people are trying to get stabilized in a substance abuse program,” said Mark P. McGovern, Ph.D., a psychologist who serves on the psychiatry faculty at Dartmouth Medical School, Hanover, N.H.

“The thought has been, you don't want to open Pandora's box and undermine the original goal of substance use stabilization,” explained Dr. McGovern in a telephone interview. “But for many patients, Pandora's box was already open and the demons were out. They were suffering nightmares, flashbacks, [and] extreme anxiety, and until you dealt with those symptoms they were never going to stop using substances.”

Dr. Thomas Kosten, professor of psychiatry at Baylor University, Houston, and research director of the VA Substance Use Disorders Quality Enhancement Research Initiative, described a similar epiphany that occurred in the PTSD treatment community, which traditionally had insisted that patients be clean and sober before beginning therapy.

“The new veterans with PTSD cannot be effectively treated with behavioral therapies like prolonged exposure unless their binge alcohol abuse is controlled,” he said. “Otherwise any gains in therapy during the week will be lost in a weekend of binge drinking, and binge drinking occurs in half of these vets. This problem is too common to ignore.”

Lisa Najavits, Ph.D., a psychologist and professor of psychiatry at Harvard Medical School, Boston, said the “big myth” that substance abuse and PTSD had to be treated sequentially persisted throughout much of the 20th century, even as a preponderance of evidence showed that severity of symptoms was higher and PTSD and addiction treatment outcomes were poorer in dually diagnosed patients than in those with just one diagnosis.

“It has really been a mini-revolution to turn that around,” said Dr. Najavits, who developed an internationally adopted dual treatment module, Seeking Safety (www.seekingsafety.org

The payoff of integrated treatment, experts agree, has offered tantalizing suggestions and some solid evidence of enhanced outcomes for symptoms of both PTSD and substance use disorders.

Once the concept was put to the test, “we realized that a great deal of 'treatment resistance' was because individuals had two, three, or four disorders, yet we were only treating one disorder,” said Dr. Kathleen T. Brady, professor of psychiatry and director of the clinical neuroscience division at the Medical University of South Carolina, Charleston.

Dr. Najavits' 25-stage integrative model, which draws on four content areas: cognitive, behavioral, and interpersonal therapy and case management, focuses on the here and now, using practical strategies for reducing anxiety, managing relationships, and incorporating “Recovery Thinking.”

Among the findings from seven empirical studies of Seeking Safety: improvements in substance use, social adjustment, general psychiatric symptoms, suicidal thoughts and planning, depression, problem solving skills, and quality of life.

In another twist on treatment delivery possibilities, Dr. McGovern recently published preliminary results of a randomized study exploring PTSD within the context of an existing addiction treatment model in 53 patients, comparing the addition of cognitive-behavioral therapy (CBT) to individual addiction counseling (Addict. Behav. 2009;34:892-97).

The now-completed study found that while both approaches led to an improvement in substance abuse disorders, the CBT component was significantly more efficacious in reducing PTSD symptoms. Furthermore, patients randomized to receive CBT “stayed in treatment at much greater rates,” he said.

One development that has made dual treatment a reality has been the availability of “excellent medications” for addiction that can allow patients to focus on PTSD treatment, Dr. Kosten said.

Depot naltrexone, which persists for a month after injection, can assist in alcohol abstention, while buprenorphine reduces the need for opiates, covering two of the substances most abused by patients with co-occurring PTSD, he said.

At times, other medications directed at PTSD symptoms, such as the alpha adrenergic blockers prazosin or doxazosin, might be useful as well.

A randomized, controlled study by researchers at Yale University, New Haven, Conn., directly compared medications (disulfiram or naltrexone) to placebo in 254 patients being treated for alcohol dependence in a 12-week study conducted at three VA outpatient clinics.

 

 

Compared with study subjects without PTSD, those with the added disorder had better alcohol use outcomes and improvement of psychiatric symptoms when they received one or other of the active medications, reported Dr. Ismene Petrakis and associates (Biol. Psychiatry 2006;60:777-83).

Another study offers insight into integrated treatment for patients with opiate addictions.

The prospective observational study found comparable reductions in drug use by patients with or without PTSD when opioid substitution was employed, even though the PTSD group had a lengthier mean history of addiction (J. Stud. Alcohol 2006;67:228-35).

The PTSD subgroup used higher doses of opiate medications, but actually attended more psychosocial treatment sessions and had better treatment retention.

“I can only speculate about the difference between outcomes… but my guess is that the patients with PTSD were more sensitive to the discomfort associated with missing a dose of methadone and thus were more motivated to get to the clinic for treatment each day,” the lead author of the study, Jodie A. Trafton, Ph.D., said in an interview.

If true, the increased-distress hypothesis, also postulated by other researchers, “might suggest that maintenance therapies or very slow tapers during detoxification might be particularly helpful for patients with these comorbidities,” said Dr. Trafton, a research health science specialist who directs the VA Program Evaluation and Resource Center in Menlo Park, Calif.

Although she is not a prescriber, Dr. Najavits advocates a medical consultation for patients with co-occurring PTSD and substance abuse, to determine whether these or other medications might be helpful during the intensive Seeking Safety program.

Because it is a difficult group to treat, strategies should aim at “giving the client as much care and support as possible,” including medication, 12-step group meetings, domestic violence counseling, parenting skills training, and HIV testing and counseling—essentially any adjunctive intervention that is relevant and scientifically sound.

“The more the better,” she said.

One challenge shared by many of the integrated therapy models is reaching potential patients who could benefit, said Dr. McGovern.

Denial is common with both diagnoses, and even patients who are ready to tackle one issue might be reluctant to acknowledge or address the other.

PTSD, for example, might present as a sleep problem or chronic pain, either of which could prompt the writing of prescriptions with the potential of exacerbating co-occurring substance abuse.

When Dr. McGovern and associates offered free evaluations and treatments for dual diagnosis patients, they were stunned at the lack of response from the community.

“We thought if we built it they would come,” he said. “We had clear recruitment challenges.”

Reaching dually diagnosed patients early, when intervention is most likely to succeed, would be aided if primary care physicians as well as psychiatrists were better trained to recognize these hidden disorders, experts agreed.

A heightened awareness and specialized training also would increase the number of providers able to treat PTSD and substance abuse.

“The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse, including urine toxicology for illicit drugs and breath alcohol [tests] as needed,” Dr. Kosten said.

His advice?

“Do not avoid discussing the use of abused drugs at the first meeting with the patient. They are more than happy to discuss it, although the younger patients do not view binge alcohol as a problem and need to be convinced.”

If patients say they can quit anytime, Dr. Kosten challenges them, asking whether they will stop for a week and monitoring their adherence with a breath alcohol test during a Monday morning appointment. He also asks permission to talk to a significant other about the patient's drinking.

“It is easy when you do it right from the start and do not wait to address the 'delicate issue' of substance abuse in a patient with PTSD,” he said. “They already know that it is a problem. Lots of friends and relatives have usually told them.”

Asked to offer advice to clinicians treating patients with co-occurring PTSD and substance abuse, Dr. Brady emphasized the heterogeneity of the disorders.

“No two patients look alike,” she said. “Every patient needs a careful evaluation and individualized treatment plan. The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work, because we [still] have a lot of uncertainties in treatment.”

Dr. Kosten disclosed that he has served on the speakers bureau for Reckitt Benkizer, maker of buprenorphine, and as a consultant to Alkermes Pharmaceuticals, which manufactures Vivitrol (naltrexone). Dr. Brady has received research support from GlaxoSmithKline and served as a consultant for Ovation Pharmaceuticals, now Lundbeck Inc. The other experts interviewed reported no relevant financial conflicts of interest.

 

 

'The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse.'

Source DR. KOSTEN

'The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work.'

Source DR. BRADY

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A revolution is brewing in the treatment of patients with co-occurring posttraumatic stress disorder and substance use, inspired by a growing body of evidence that the disorders can be successfully addressed simultaneously.

An estimated half of returning veterans and a third of civilians with PTSD have co-occurring substance abuse, while up to 42% of people in treatment for addictions have a current diagnosis of PTSD. Yet, few programs traditionally addressed both issues simultaneously.

Patients presenting with PTSD were excluded from research studies and many treatment programs if they had an ongoing substance use problem.

Barriers blocked the route to dual treatment at substance abuse clinics as well, where clinicians were reticent to address, much less treat, PTSD.

“There's been a kind of historical trepidation to deal with PTSD when people are trying to get stabilized in a substance abuse program,” said Mark P. McGovern, Ph.D., a psychologist who serves on the psychiatry faculty at Dartmouth Medical School, Hanover, N.H.

“The thought has been, you don't want to open Pandora's box and undermine the original goal of substance use stabilization,” explained Dr. McGovern in a telephone interview. “But for many patients, Pandora's box was already open and the demons were out. They were suffering nightmares, flashbacks, [and] extreme anxiety, and until you dealt with those symptoms they were never going to stop using substances.”

Dr. Thomas Kosten, professor of psychiatry at Baylor University, Houston, and research director of the VA Substance Use Disorders Quality Enhancement Research Initiative, described a similar epiphany that occurred in the PTSD treatment community, which traditionally had insisted that patients be clean and sober before beginning therapy.

“The new veterans with PTSD cannot be effectively treated with behavioral therapies like prolonged exposure unless their binge alcohol abuse is controlled,” he said. “Otherwise any gains in therapy during the week will be lost in a weekend of binge drinking, and binge drinking occurs in half of these vets. This problem is too common to ignore.”

Lisa Najavits, Ph.D., a psychologist and professor of psychiatry at Harvard Medical School, Boston, said the “big myth” that substance abuse and PTSD had to be treated sequentially persisted throughout much of the 20th century, even as a preponderance of evidence showed that severity of symptoms was higher and PTSD and addiction treatment outcomes were poorer in dually diagnosed patients than in those with just one diagnosis.

“It has really been a mini-revolution to turn that around,” said Dr. Najavits, who developed an internationally adopted dual treatment module, Seeking Safety (www.seekingsafety.org

The payoff of integrated treatment, experts agree, has offered tantalizing suggestions and some solid evidence of enhanced outcomes for symptoms of both PTSD and substance use disorders.

Once the concept was put to the test, “we realized that a great deal of 'treatment resistance' was because individuals had two, three, or four disorders, yet we were only treating one disorder,” said Dr. Kathleen T. Brady, professor of psychiatry and director of the clinical neuroscience division at the Medical University of South Carolina, Charleston.

Dr. Najavits' 25-stage integrative model, which draws on four content areas: cognitive, behavioral, and interpersonal therapy and case management, focuses on the here and now, using practical strategies for reducing anxiety, managing relationships, and incorporating “Recovery Thinking.”

Among the findings from seven empirical studies of Seeking Safety: improvements in substance use, social adjustment, general psychiatric symptoms, suicidal thoughts and planning, depression, problem solving skills, and quality of life.

In another twist on treatment delivery possibilities, Dr. McGovern recently published preliminary results of a randomized study exploring PTSD within the context of an existing addiction treatment model in 53 patients, comparing the addition of cognitive-behavioral therapy (CBT) to individual addiction counseling (Addict. Behav. 2009;34:892-97).

The now-completed study found that while both approaches led to an improvement in substance abuse disorders, the CBT component was significantly more efficacious in reducing PTSD symptoms. Furthermore, patients randomized to receive CBT “stayed in treatment at much greater rates,” he said.

One development that has made dual treatment a reality has been the availability of “excellent medications” for addiction that can allow patients to focus on PTSD treatment, Dr. Kosten said.

Depot naltrexone, which persists for a month after injection, can assist in alcohol abstention, while buprenorphine reduces the need for opiates, covering two of the substances most abused by patients with co-occurring PTSD, he said.

At times, other medications directed at PTSD symptoms, such as the alpha adrenergic blockers prazosin or doxazosin, might be useful as well.

A randomized, controlled study by researchers at Yale University, New Haven, Conn., directly compared medications (disulfiram or naltrexone) to placebo in 254 patients being treated for alcohol dependence in a 12-week study conducted at three VA outpatient clinics.

 

 

Compared with study subjects without PTSD, those with the added disorder had better alcohol use outcomes and improvement of psychiatric symptoms when they received one or other of the active medications, reported Dr. Ismene Petrakis and associates (Biol. Psychiatry 2006;60:777-83).

Another study offers insight into integrated treatment for patients with opiate addictions.

The prospective observational study found comparable reductions in drug use by patients with or without PTSD when opioid substitution was employed, even though the PTSD group had a lengthier mean history of addiction (J. Stud. Alcohol 2006;67:228-35).

The PTSD subgroup used higher doses of opiate medications, but actually attended more psychosocial treatment sessions and had better treatment retention.

“I can only speculate about the difference between outcomes… but my guess is that the patients with PTSD were more sensitive to the discomfort associated with missing a dose of methadone and thus were more motivated to get to the clinic for treatment each day,” the lead author of the study, Jodie A. Trafton, Ph.D., said in an interview.

If true, the increased-distress hypothesis, also postulated by other researchers, “might suggest that maintenance therapies or very slow tapers during detoxification might be particularly helpful for patients with these comorbidities,” said Dr. Trafton, a research health science specialist who directs the VA Program Evaluation and Resource Center in Menlo Park, Calif.

Although she is not a prescriber, Dr. Najavits advocates a medical consultation for patients with co-occurring PTSD and substance abuse, to determine whether these or other medications might be helpful during the intensive Seeking Safety program.

Because it is a difficult group to treat, strategies should aim at “giving the client as much care and support as possible,” including medication, 12-step group meetings, domestic violence counseling, parenting skills training, and HIV testing and counseling—essentially any adjunctive intervention that is relevant and scientifically sound.

“The more the better,” she said.

One challenge shared by many of the integrated therapy models is reaching potential patients who could benefit, said Dr. McGovern.

Denial is common with both diagnoses, and even patients who are ready to tackle one issue might be reluctant to acknowledge or address the other.

PTSD, for example, might present as a sleep problem or chronic pain, either of which could prompt the writing of prescriptions with the potential of exacerbating co-occurring substance abuse.

When Dr. McGovern and associates offered free evaluations and treatments for dual diagnosis patients, they were stunned at the lack of response from the community.

“We thought if we built it they would come,” he said. “We had clear recruitment challenges.”

Reaching dually diagnosed patients early, when intervention is most likely to succeed, would be aided if primary care physicians as well as psychiatrists were better trained to recognize these hidden disorders, experts agreed.

A heightened awareness and specialized training also would increase the number of providers able to treat PTSD and substance abuse.

“The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse, including urine toxicology for illicit drugs and breath alcohol [tests] as needed,” Dr. Kosten said.

His advice?

“Do not avoid discussing the use of abused drugs at the first meeting with the patient. They are more than happy to discuss it, although the younger patients do not view binge alcohol as a problem and need to be convinced.”

If patients say they can quit anytime, Dr. Kosten challenges them, asking whether they will stop for a week and monitoring their adherence with a breath alcohol test during a Monday morning appointment. He also asks permission to talk to a significant other about the patient's drinking.

“It is easy when you do it right from the start and do not wait to address the 'delicate issue' of substance abuse in a patient with PTSD,” he said. “They already know that it is a problem. Lots of friends and relatives have usually told them.”

Asked to offer advice to clinicians treating patients with co-occurring PTSD and substance abuse, Dr. Brady emphasized the heterogeneity of the disorders.

“No two patients look alike,” she said. “Every patient needs a careful evaluation and individualized treatment plan. The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work, because we [still] have a lot of uncertainties in treatment.”

Dr. Kosten disclosed that he has served on the speakers bureau for Reckitt Benkizer, maker of buprenorphine, and as a consultant to Alkermes Pharmaceuticals, which manufactures Vivitrol (naltrexone). Dr. Brady has received research support from GlaxoSmithKline and served as a consultant for Ovation Pharmaceuticals, now Lundbeck Inc. The other experts interviewed reported no relevant financial conflicts of interest.

 

 

'The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse.'

Source DR. KOSTEN

'The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work.'

Source DR. BRADY

A revolution is brewing in the treatment of patients with co-occurring posttraumatic stress disorder and substance use, inspired by a growing body of evidence that the disorders can be successfully addressed simultaneously.

An estimated half of returning veterans and a third of civilians with PTSD have co-occurring substance abuse, while up to 42% of people in treatment for addictions have a current diagnosis of PTSD. Yet, few programs traditionally addressed both issues simultaneously.

Patients presenting with PTSD were excluded from research studies and many treatment programs if they had an ongoing substance use problem.

Barriers blocked the route to dual treatment at substance abuse clinics as well, where clinicians were reticent to address, much less treat, PTSD.

“There's been a kind of historical trepidation to deal with PTSD when people are trying to get stabilized in a substance abuse program,” said Mark P. McGovern, Ph.D., a psychologist who serves on the psychiatry faculty at Dartmouth Medical School, Hanover, N.H.

“The thought has been, you don't want to open Pandora's box and undermine the original goal of substance use stabilization,” explained Dr. McGovern in a telephone interview. “But for many patients, Pandora's box was already open and the demons were out. They were suffering nightmares, flashbacks, [and] extreme anxiety, and until you dealt with those symptoms they were never going to stop using substances.”

Dr. Thomas Kosten, professor of psychiatry at Baylor University, Houston, and research director of the VA Substance Use Disorders Quality Enhancement Research Initiative, described a similar epiphany that occurred in the PTSD treatment community, which traditionally had insisted that patients be clean and sober before beginning therapy.

“The new veterans with PTSD cannot be effectively treated with behavioral therapies like prolonged exposure unless their binge alcohol abuse is controlled,” he said. “Otherwise any gains in therapy during the week will be lost in a weekend of binge drinking, and binge drinking occurs in half of these vets. This problem is too common to ignore.”

Lisa Najavits, Ph.D., a psychologist and professor of psychiatry at Harvard Medical School, Boston, said the “big myth” that substance abuse and PTSD had to be treated sequentially persisted throughout much of the 20th century, even as a preponderance of evidence showed that severity of symptoms was higher and PTSD and addiction treatment outcomes were poorer in dually diagnosed patients than in those with just one diagnosis.

“It has really been a mini-revolution to turn that around,” said Dr. Najavits, who developed an internationally adopted dual treatment module, Seeking Safety (www.seekingsafety.org

The payoff of integrated treatment, experts agree, has offered tantalizing suggestions and some solid evidence of enhanced outcomes for symptoms of both PTSD and substance use disorders.

Once the concept was put to the test, “we realized that a great deal of 'treatment resistance' was because individuals had two, three, or four disorders, yet we were only treating one disorder,” said Dr. Kathleen T. Brady, professor of psychiatry and director of the clinical neuroscience division at the Medical University of South Carolina, Charleston.

Dr. Najavits' 25-stage integrative model, which draws on four content areas: cognitive, behavioral, and interpersonal therapy and case management, focuses on the here and now, using practical strategies for reducing anxiety, managing relationships, and incorporating “Recovery Thinking.”

Among the findings from seven empirical studies of Seeking Safety: improvements in substance use, social adjustment, general psychiatric symptoms, suicidal thoughts and planning, depression, problem solving skills, and quality of life.

In another twist on treatment delivery possibilities, Dr. McGovern recently published preliminary results of a randomized study exploring PTSD within the context of an existing addiction treatment model in 53 patients, comparing the addition of cognitive-behavioral therapy (CBT) to individual addiction counseling (Addict. Behav. 2009;34:892-97).

The now-completed study found that while both approaches led to an improvement in substance abuse disorders, the CBT component was significantly more efficacious in reducing PTSD symptoms. Furthermore, patients randomized to receive CBT “stayed in treatment at much greater rates,” he said.

One development that has made dual treatment a reality has been the availability of “excellent medications” for addiction that can allow patients to focus on PTSD treatment, Dr. Kosten said.

Depot naltrexone, which persists for a month after injection, can assist in alcohol abstention, while buprenorphine reduces the need for opiates, covering two of the substances most abused by patients with co-occurring PTSD, he said.

At times, other medications directed at PTSD symptoms, such as the alpha adrenergic blockers prazosin or doxazosin, might be useful as well.

A randomized, controlled study by researchers at Yale University, New Haven, Conn., directly compared medications (disulfiram or naltrexone) to placebo in 254 patients being treated for alcohol dependence in a 12-week study conducted at three VA outpatient clinics.

 

 

Compared with study subjects without PTSD, those with the added disorder had better alcohol use outcomes and improvement of psychiatric symptoms when they received one or other of the active medications, reported Dr. Ismene Petrakis and associates (Biol. Psychiatry 2006;60:777-83).

Another study offers insight into integrated treatment for patients with opiate addictions.

The prospective observational study found comparable reductions in drug use by patients with or without PTSD when opioid substitution was employed, even though the PTSD group had a lengthier mean history of addiction (J. Stud. Alcohol 2006;67:228-35).

The PTSD subgroup used higher doses of opiate medications, but actually attended more psychosocial treatment sessions and had better treatment retention.

“I can only speculate about the difference between outcomes… but my guess is that the patients with PTSD were more sensitive to the discomfort associated with missing a dose of methadone and thus were more motivated to get to the clinic for treatment each day,” the lead author of the study, Jodie A. Trafton, Ph.D., said in an interview.

If true, the increased-distress hypothesis, also postulated by other researchers, “might suggest that maintenance therapies or very slow tapers during detoxification might be particularly helpful for patients with these comorbidities,” said Dr. Trafton, a research health science specialist who directs the VA Program Evaluation and Resource Center in Menlo Park, Calif.

Although she is not a prescriber, Dr. Najavits advocates a medical consultation for patients with co-occurring PTSD and substance abuse, to determine whether these or other medications might be helpful during the intensive Seeking Safety program.

Because it is a difficult group to treat, strategies should aim at “giving the client as much care and support as possible,” including medication, 12-step group meetings, domestic violence counseling, parenting skills training, and HIV testing and counseling—essentially any adjunctive intervention that is relevant and scientifically sound.

“The more the better,” she said.

One challenge shared by many of the integrated therapy models is reaching potential patients who could benefit, said Dr. McGovern.

Denial is common with both diagnoses, and even patients who are ready to tackle one issue might be reluctant to acknowledge or address the other.

PTSD, for example, might present as a sleep problem or chronic pain, either of which could prompt the writing of prescriptions with the potential of exacerbating co-occurring substance abuse.

When Dr. McGovern and associates offered free evaluations and treatments for dual diagnosis patients, they were stunned at the lack of response from the community.

“We thought if we built it they would come,” he said. “We had clear recruitment challenges.”

Reaching dually diagnosed patients early, when intervention is most likely to succeed, would be aided if primary care physicians as well as psychiatrists were better trained to recognize these hidden disorders, experts agreed.

A heightened awareness and specialized training also would increase the number of providers able to treat PTSD and substance abuse.

“The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse, including urine toxicology for illicit drugs and breath alcohol [tests] as needed,” Dr. Kosten said.

His advice?

“Do not avoid discussing the use of abused drugs at the first meeting with the patient. They are more than happy to discuss it, although the younger patients do not view binge alcohol as a problem and need to be convinced.”

If patients say they can quit anytime, Dr. Kosten challenges them, asking whether they will stop for a week and monitoring their adherence with a breath alcohol test during a Monday morning appointment. He also asks permission to talk to a significant other about the patient's drinking.

“It is easy when you do it right from the start and do not wait to address the 'delicate issue' of substance abuse in a patient with PTSD,” he said. “They already know that it is a problem. Lots of friends and relatives have usually told them.”

Asked to offer advice to clinicians treating patients with co-occurring PTSD and substance abuse, Dr. Brady emphasized the heterogeneity of the disorders.

“No two patients look alike,” she said. “Every patient needs a careful evaluation and individualized treatment plan. The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work, because we [still] have a lot of uncertainties in treatment.”

Dr. Kosten disclosed that he has served on the speakers bureau for Reckitt Benkizer, maker of buprenorphine, and as a consultant to Alkermes Pharmaceuticals, which manufactures Vivitrol (naltrexone). Dr. Brady has received research support from GlaxoSmithKline and served as a consultant for Ovation Pharmaceuticals, now Lundbeck Inc. The other experts interviewed reported no relevant financial conflicts of interest.

 

 

'The hardest thing for nonsubstance abuse providers to do is ask and monitor for substance abuse.'

Source DR. KOSTEN

'The treatment provider must be flexible—ready to change treatment strategies if what they initially try doesn't work.'

Source DR. BRADY

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Pandemic H1N1 Virus May Hit U.S. in Waves

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Thu, 12/06/2018 - 14:43
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Pandemic H1N1 Virus May Hit U.S. in Waves

Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said.

“We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, more than 97,000 Americans had been hospitalized for H1N1 influenza anrough Oct. 17, and 3,983 patients died, of whom 540 were children.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages would ease.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Vaccine distribution also was hampered by early problems with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the “roll-out of a new restaurant.”

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “it seems that we were getting some pretty rosy scenarios,” she said.

It turned out that the “yield was lower than anticipated.”

Subsequently, however, a “robust” supply of a safe and efficacious vaccine was on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

“It is frustrating to stand in line and wait for vaccine,” Sec. Napolitano acknowledged.

“For those who are ill or whose loved ones have passed away, our sympathies couldn't be higher,” she said. “But this is not a situation that is cause for panic. We have vaccine. It is being produced. It is being distributed.”

All 50 states and U.S. territories have ordered vaccine, which is distributed on a per capita basis, she noted.

Sec. Napolitano emphasized that the specifics of vaccine clinics and prioritization of recipients are managed on a state and local level, analogous to national disaster response.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts.” But “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. were directly calling their pregnant patients into their offices for H1N1 vaccination.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices were expected to become less difficult as a result of distribution of a total of 250 million doses of vaccine — far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

Sec. Sebelius directed consumers to flu.gov

A new link on the Web site (flu.gov/evaluation

'We could see months of disease outbreaks rising and falling.'

Source SEC. SEBELIUS

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Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said.

“We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, more than 97,000 Americans had been hospitalized for H1N1 influenza anrough Oct. 17, and 3,983 patients died, of whom 540 were children.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages would ease.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Vaccine distribution also was hampered by early problems with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the “roll-out of a new restaurant.”

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “it seems that we were getting some pretty rosy scenarios,” she said.

It turned out that the “yield was lower than anticipated.”

Subsequently, however, a “robust” supply of a safe and efficacious vaccine was on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

“It is frustrating to stand in line and wait for vaccine,” Sec. Napolitano acknowledged.

“For those who are ill or whose loved ones have passed away, our sympathies couldn't be higher,” she said. “But this is not a situation that is cause for panic. We have vaccine. It is being produced. It is being distributed.”

All 50 states and U.S. territories have ordered vaccine, which is distributed on a per capita basis, she noted.

Sec. Napolitano emphasized that the specifics of vaccine clinics and prioritization of recipients are managed on a state and local level, analogous to national disaster response.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts.” But “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. were directly calling their pregnant patients into their offices for H1N1 vaccination.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices were expected to become less difficult as a result of distribution of a total of 250 million doses of vaccine — far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

Sec. Sebelius directed consumers to flu.gov

A new link on the Web site (flu.gov/evaluation

'We could see months of disease outbreaks rising and falling.'

Source SEC. SEBELIUS

Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said.

“We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, more than 97,000 Americans had been hospitalized for H1N1 influenza anrough Oct. 17, and 3,983 patients died, of whom 540 were children.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages would ease.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Vaccine distribution also was hampered by early problems with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the “roll-out of a new restaurant.”

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “it seems that we were getting some pretty rosy scenarios,” she said.

It turned out that the “yield was lower than anticipated.”

Subsequently, however, a “robust” supply of a safe and efficacious vaccine was on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

“It is frustrating to stand in line and wait for vaccine,” Sec. Napolitano acknowledged.

“For those who are ill or whose loved ones have passed away, our sympathies couldn't be higher,” she said. “But this is not a situation that is cause for panic. We have vaccine. It is being produced. It is being distributed.”

All 50 states and U.S. territories have ordered vaccine, which is distributed on a per capita basis, she noted.

Sec. Napolitano emphasized that the specifics of vaccine clinics and prioritization of recipients are managed on a state and local level, analogous to national disaster response.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts.” But “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. were directly calling their pregnant patients into their offices for H1N1 vaccination.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices were expected to become less difficult as a result of distribution of a total of 250 million doses of vaccine — far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

Sec. Sebelius directed consumers to flu.gov

A new link on the Web site (flu.gov/evaluation

'We could see months of disease outbreaks rising and falling.'

Source SEC. SEBELIUS

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H1N1 Flu Outbreaks Could Come in Waves

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Fri, 01/11/2019 - 10:33
Display Headline
H1N1 Flu Outbreaks Could Come in Waves

Americans may need to brace for a long winter of "rising and falling" waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, "may be overly optimistic," she said. "It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know."

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring.

"We could see months of disease outbreaks rising and falling," she said.

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

The distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the "roll-out of a new restaurant."

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, "It seems that we were getting some pretty rosy scenarios," she said. "Yield was lower than anticipated."

Today, however, a "robust" supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing "actions and assistance … well grounded in science and well grounded in facts." But "nobody is sitting here in [Washington]" deciding, for example, where pregnant women in Arizona should go for a vaccine, said Sec. Sebelius.

Some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to , a government Web site where vaccination clinic locations are being updated continually.

A new link on the Web site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, "not to take the place of anyone's doctor" but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the "worried well [so they do not] overwhelm our health care providers," said Sec. Sebelius.

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Americans may need to brace for a long winter of "rising and falling" waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, "may be overly optimistic," she said. "It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know."

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring.

"We could see months of disease outbreaks rising and falling," she said.

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

The distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the "roll-out of a new restaurant."

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, "It seems that we were getting some pretty rosy scenarios," she said. "Yield was lower than anticipated."

Today, however, a "robust" supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing "actions and assistance … well grounded in science and well grounded in facts." But "nobody is sitting here in [Washington]" deciding, for example, where pregnant women in Arizona should go for a vaccine, said Sec. Sebelius.

Some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to , a government Web site where vaccination clinic locations are being updated continually.

A new link on the Web site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, "not to take the place of anyone's doctor" but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the "worried well [so they do not] overwhelm our health care providers," said Sec. Sebelius.

flu.gov

Americans may need to brace for a long winter of "rising and falling" waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, "may be overly optimistic," she said. "It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know."

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring.

"We could see months of disease outbreaks rising and falling," she said.

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

The distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production line schedule, which she compared to glitches associated with the "roll-out of a new restaurant."

When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, "It seems that we were getting some pretty rosy scenarios," she said. "Yield was lower than anticipated."

Today, however, a "robust" supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing "actions and assistance … well grounded in science and well grounded in facts." But "nobody is sitting here in [Washington]" deciding, for example, where pregnant women in Arizona should go for a vaccine, said Sec. Sebelius.

Some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to , a government Web site where vaccination clinic locations are being updated continually.

A new link on the Web site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, "not to take the place of anyone's doctor" but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the "worried well [so they do not] overwhelm our health care providers," said Sec. Sebelius.

flu.gov

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Health Care Field Not Immune to Vaccine Myths

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Health care workers harbor significant fears and misconceptions about influenza vaccination, according to the results of a survey conducted at a large tertiary children's hospital in the Midwestern United States.

Researchers in Kansas City, Mo., administered a 44-question survey to 63 physicians, 135 nurses, and 376 allied health care workers at a 317-bed children's hospital where rates of seasonal influenza immunization are high, Dr. Mary Anne Jackson said at a press conference during the annual meeting of the Infectious Diseases Society of America (IDSA).

Results of the study were "somewhat surprising" for a highly educated, highly immunized group of health care workers who are known to be at high risk of acquiring seasonal influenza and passing it on to vulnerable patients, said Dr. Jackson, chief of infectious diseases at Children's Mercy Hospital in Kansas City.

She pointed to "significant gaps in knowledge" about transmission, nosocomial spread, and vaccine efficacy and safety among all levels of health care professionals. Accurate knowledge "wasn't 100% even for physicians," she said.

Still, physicians were significantly more likely than nurses or other health care workers (P value less than .0001) to know that they are at high risk of influenza; that the vaccine prevents spread of the disease; and that it is a safe vaccine for adults and children.

Compared with physicians, other health care workers were significantly more likely to erroneously believe that the vaccine can cause influenza.

About 75% of physicians advocated policies mandating influenza immunization among health care workers, compared with fewer than half of nurses or allied health care professionals surveyed.

Mandating influenza immunization for health care workers, a highly controversial proposition briefly enacted in New York State in response to the H1N1 influenza pandemic this year, was rescinded by New York Gov. David A. Paterson. The governor's office stated that the mandatory vaccination policy for health care workers was dropped due to shortages of vaccine for high-risk populations. Widespread protests, however, were speculated to have played a role in the decision as well.

Based on her study findings and recent public responses to H1N1 vaccine mandates for health care workers, Dr. Jackson concluded that "mandates are going to be difficult."

On the other hand, educational efforts and campaigns aimed at getting health care workers immunized "have failed dismally in most institutions."

At Children's Mercy Hospital, a vigorous campaign conducted over several years finally achieved an 85% influenza vaccine rate among employees, compared with an average 40% rate among health care workers across the country.

Dr. Jackson reported no relevant financial disclosures.

There are 'gaps in knowledge' about transmission, nosocomial spread, and vaccine efficacy.

Source Dr. Jackson

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Health care workers harbor significant fears and misconceptions about influenza vaccination, according to the results of a survey conducted at a large tertiary children's hospital in the Midwestern United States.

Researchers in Kansas City, Mo., administered a 44-question survey to 63 physicians, 135 nurses, and 376 allied health care workers at a 317-bed children's hospital where rates of seasonal influenza immunization are high, Dr. Mary Anne Jackson said at a press conference during the annual meeting of the Infectious Diseases Society of America (IDSA).

Results of the study were "somewhat surprising" for a highly educated, highly immunized group of health care workers who are known to be at high risk of acquiring seasonal influenza and passing it on to vulnerable patients, said Dr. Jackson, chief of infectious diseases at Children's Mercy Hospital in Kansas City.

She pointed to "significant gaps in knowledge" about transmission, nosocomial spread, and vaccine efficacy and safety among all levels of health care professionals. Accurate knowledge "wasn't 100% even for physicians," she said.

Still, physicians were significantly more likely than nurses or other health care workers (P value less than .0001) to know that they are at high risk of influenza; that the vaccine prevents spread of the disease; and that it is a safe vaccine for adults and children.

Compared with physicians, other health care workers were significantly more likely to erroneously believe that the vaccine can cause influenza.

About 75% of physicians advocated policies mandating influenza immunization among health care workers, compared with fewer than half of nurses or allied health care professionals surveyed.

Mandating influenza immunization for health care workers, a highly controversial proposition briefly enacted in New York State in response to the H1N1 influenza pandemic this year, was rescinded by New York Gov. David A. Paterson. The governor's office stated that the mandatory vaccination policy for health care workers was dropped due to shortages of vaccine for high-risk populations. Widespread protests, however, were speculated to have played a role in the decision as well.

Based on her study findings and recent public responses to H1N1 vaccine mandates for health care workers, Dr. Jackson concluded that "mandates are going to be difficult."

On the other hand, educational efforts and campaigns aimed at getting health care workers immunized "have failed dismally in most institutions."

At Children's Mercy Hospital, a vigorous campaign conducted over several years finally achieved an 85% influenza vaccine rate among employees, compared with an average 40% rate among health care workers across the country.

Dr. Jackson reported no relevant financial disclosures.

There are 'gaps in knowledge' about transmission, nosocomial spread, and vaccine efficacy.

Source Dr. Jackson

Health care workers harbor significant fears and misconceptions about influenza vaccination, according to the results of a survey conducted at a large tertiary children's hospital in the Midwestern United States.

Researchers in Kansas City, Mo., administered a 44-question survey to 63 physicians, 135 nurses, and 376 allied health care workers at a 317-bed children's hospital where rates of seasonal influenza immunization are high, Dr. Mary Anne Jackson said at a press conference during the annual meeting of the Infectious Diseases Society of America (IDSA).

Results of the study were "somewhat surprising" for a highly educated, highly immunized group of health care workers who are known to be at high risk of acquiring seasonal influenza and passing it on to vulnerable patients, said Dr. Jackson, chief of infectious diseases at Children's Mercy Hospital in Kansas City.

She pointed to "significant gaps in knowledge" about transmission, nosocomial spread, and vaccine efficacy and safety among all levels of health care professionals. Accurate knowledge "wasn't 100% even for physicians," she said.

Still, physicians were significantly more likely than nurses or other health care workers (P value less than .0001) to know that they are at high risk of influenza; that the vaccine prevents spread of the disease; and that it is a safe vaccine for adults and children.

Compared with physicians, other health care workers were significantly more likely to erroneously believe that the vaccine can cause influenza.

About 75% of physicians advocated policies mandating influenza immunization among health care workers, compared with fewer than half of nurses or allied health care professionals surveyed.

Mandating influenza immunization for health care workers, a highly controversial proposition briefly enacted in New York State in response to the H1N1 influenza pandemic this year, was rescinded by New York Gov. David A. Paterson. The governor's office stated that the mandatory vaccination policy for health care workers was dropped due to shortages of vaccine for high-risk populations. Widespread protests, however, were speculated to have played a role in the decision as well.

Based on her study findings and recent public responses to H1N1 vaccine mandates for health care workers, Dr. Jackson concluded that "mandates are going to be difficult."

On the other hand, educational efforts and campaigns aimed at getting health care workers immunized "have failed dismally in most institutions."

At Children's Mercy Hospital, a vigorous campaign conducted over several years finally achieved an 85% influenza vaccine rate among employees, compared with an average 40% rate among health care workers across the country.

Dr. Jackson reported no relevant financial disclosures.

There are 'gaps in knowledge' about transmission, nosocomial spread, and vaccine efficacy.

Source Dr. Jackson

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H1N1 Flu Outbreaks Could Come in Waves

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Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said. “We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production schedule. When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “It seems that we were getting some pretty rosy scenarios,” she said.

Today, however, a “robust” supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts,” said Sec. Napolitano, but “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. are directly calling pregnant patients into their offices for H1N1 vaccination. Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to flu.gov, a government site where vaccination clinic locations are continually updated. A new link on the site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, “not to take the place of anyone's doctor” but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the “worried well … [so they do not] overwhelm our health care providers,” said Sec. Sebelius.

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Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said. “We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production schedule. When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “It seems that we were getting some pretty rosy scenarios,” she said.

Today, however, a “robust” supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts,” said Sec. Napolitano, but “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. are directly calling pregnant patients into their offices for H1N1 vaccination. Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to flu.gov, a government site where vaccination clinic locations are continually updated. A new link on the site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, “not to take the place of anyone's doctor” but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the “worried well … [so they do not] overwhelm our health care providers,” said Sec. Sebelius.

Americans may need to brace for a long winter of “rising and falling” waves of pandemic influenza A(H1N1) outbreaks, Kathleen Sebelius, Secretary of the Department of Health and Human Services, warned during a telebriefing.

The notion that the H1N1 pandemic may have peaked in October, as it became widespread in 46 states, “may be overly optimistic,” she said. “It is totally unpredictable what's going to happen. How many [bell] curves we will see, our scientists tell me they don't know.”

During the 1950s, rolling waves of serious influenza outbreaks buffeted various regions of the country, with peaks occurring both in the fall and the winter. The same phenomenon may occur this year and even into the spring, she said. “We could see months of disease outbreaks rising and falling.”

According to the most recent figures available, nearly 22,000 Americans had been hospitalized for influenza and pneumonia syndromes since Aug. 30, and there had been 2,416 deaths. During that time, 53 children had also died.

Unlike most years, this year's powerful fall influenza season followed a spike last spring of cases and hospitalizations, most from the H1N1 strain.

Both Sec. Sebelius and Janet Napolitano, Secretary of the Department of Homeland Security, offered reassurances at their joint press conference that widespread vaccine shortages will soon ease considerably.

Unforeseen problems with manufacturing of the H1N1 vaccine led to sluggish production in the early weeks of an outbreak that quickly spread throughout the country, outpacing health officials' ability to provide inoculations to groups considered at high risk of complications, including pregnant women, children and young adults, caregivers of infants, health care workers, and people with underlying medical conditions.

Sec. Sebelius explained that the H1N1 virus strain proved to grow slowly using 50-year-old egg-based technology, which is considered safe but sluggish in comparison with experimental cell-based technologies that have yet to be fully evaluated and approved.

Distribution of vaccine also was hampered by early snafus with manufacturers' stepped-up production schedule. When scenarios were first conceived about how to ramp up production and distribution in anticipation of the fall outbreak, “It seems that we were getting some pretty rosy scenarios,” she said.

Today, however, a “robust” supply of a safe and efficacious vaccine is on its way to 150,000 vaccination sites from five manufacturers, with state and local governments deciding who to vaccinate first, where, and when, she said.

The federal government in this case is providing “actions and assistance … well grounded in science and well grounded in facts,” said Sec. Napolitano, but “nobody is sitting here in [Washington]” deciding, for example, where pregnant women in Arizona should go for a vaccine.

Sec. Sebelius said some school-based clinics in Maryland that had already planned to administer seasonal flu shots decided to direct limited H1N1 vaccine supplies there first.

In Illinois and some states in the Northeast, ob.gyns. are directly calling pregnant patients into their offices for H1N1 vaccination. Other localities decided to concentrate on vaccinating health care workers as their highest priority.

Such choices will become less difficult in the coming weeks, as a total of 250 million doses of vaccine are distributed, far more than the 100 million doses of seasonal influenza vaccine typically produced for the nation, she said.

In the meantime, Sec. Sebelius directed consumers to flu.gov, a government site where vaccination clinic locations are continually updated. A new link on the site (flu.gov/evaluation) enables consumers to connect to an H1N1 Flu Self-Evaluation tool, “not to take the place of anyone's doctor” but to alert high-risk individuals to the need for seeking a vaccination or medical care, and to reassure the “worried well … [so they do not] overwhelm our health care providers,” said Sec. Sebelius.

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