News for Your Practice

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.

“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.¹

The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.²

Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”³

Johnson wrote: “J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA.”³

A more profound problem

Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.¹

“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.

Legislation to help the FDA reject a device

In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.

“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.⁴

We want to hear from you! Tell us what you think.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

Concern over a relationship between in vitro fertilization (IVF) and subsequent breast cancer has been ameliorated by a large study conducted in Australia. The authors report no overall increase in the rate of breast cancer in women who undergo IVF. However, there does seem to be a higher risk of breast cancer in those who begin IVF treatment when in their mid-20s.

A population-based study from Western Australia studied the incidence rate of breast cancer in a large cohort (n=21,025) aged 20 to 44 years who underwent hospital-based treatment for infertility. Researchers compared the rate of breast cancer in women who had IVF with those who had fertility treatment but not IVF.

The study, published in Fertility and Sterility, reports that there is no overall increase in the risk of breast cancer for women who undergo hospital-based IVF (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.88–1.36).

“For younger women,” write the authors, “there is some cause for concern, because it appears that they may face an increased risk of breast cancer after IVF treatment.”

Women who began hospital infertility treatment at 24 years of age and required IVF had an unadjusted HR of breast cancer of 1.59 (95% CI, 1.05–2.42) compared with women of the same age who had infertility treatment but no IVF.

When adjusted for late age at first delivery, which is associated with an increased rate of breast cancer, and delivery of twins and higher-order multiples, which is associated with a decreased rate of breast cancer, the HR remained elevated at 1.56 (95% CI, 1.01–2.40).

“The results of this study will be reassuring to women who commence IVF treatment in their 30s and 40s because, for these women, there appears to be no direct association between IVF treatment and breast cancer risk,” write the authors. Risk was not elevated in women who commenced treatment at age 40 and required IVF (adjusted HR, 0.87; 95% CI, 0.62–1.22).

“Nevertheless, women should be aware that delivering their first child late in reproductive life, whether assisted by IVF or not, is associated with an increased risk of breast cancer.”

Access to the full-text article is available at http://bit.ly/KiLvwh.

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

We want to hear from you! Tell us what you think.

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

We want to hear from you! Tell us what you think.

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

We want to hear from you! Tell us what you think.

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

We want to hear from you! Tell us what you think.

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

We want to hear from you! Tell us what you think.

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

We want to hear from you! Tell us what you think.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

After a review of recent epidemiologic studies, the US Food and Drug Administration (FDA) concluded that there is a higher risk of blood clots in women taking drospirenone-containing oral contraceptives (OCs) than in women taking other progestin-containing OCs.

The FDA now requires that manufacturers add this information to the labels of drospirenone-containing OCs.

Before prescribing these drugs, health-care professionals are strongly advised to weigh the risks and benefits of drospirenone-containing OCs against a woman’s other risk factors for developing a blood clot.

Oral contraceptives that contain drospirenone/ethinyl estradiol are Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Inconsistent results

The studies reviewed by the FDA did not provide consistent estimates of the comparative risk of blood clots associated with various oral contraceptives that did or did not contain drospirenone. Nor did they account for patient characteristics that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk of blood clots seen in some of the studies is actually due to drospirenone-containing OCs.

Bayer, the manufacturer of Beyaz, Safyral, Yasmin, and Yaz, will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared with products containing levonorgestrel or some other progestinsâ€"whereas other epidemiologic studies found no additional risk of blood clots. The labels will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Risk is still lower than in pregnancy and postpartum

The FDA notes: "To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."1

The likelihood of developing a blood clot is greatest (40 to 65 cases for every 10,000 women) during the postpartum period; moderately risky (5 to 20 for every 10,000) during pregnancy; less risky (3 to 9 for every 10,000) in combination oral contraceptive users; and least risky (1 to 5 for every 10,000) for nonpregnant, noncombination oral contraceptive users.1

For the US FDA Drug Safety Communication published on April 10, 2012, click here.

We want to hear from you!  Tell us what you think.

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

New guidelines are unlikely to lower the incidence of cervical cancer

What is the likely overall impact of new guidelines recommending less screening for cervical cancer?

We put this question—and others—to public health expert Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California–Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky serves as an OBG Management contributing editor. His responses offer a thoughtful commentary on the pressing issue of reducing the rate of cervical cancer in the United States.

“We have no evidence that any screening strategy will lower the cancer rate with any combination of cytology innovation or HPV test innovation,” he says. “These guidelines purely focus on ‘holding the gains’ on the current cancer incidence in the United States.”

OBG Management: Could you elaborate?

Dr. Lonky: The guidelines ask, “Are we wasting money?” and “Are we putting more women at risk with frequent testing?” They also go on to suggest that extra screening is prone to false-positive work-ups. They state that only CIN 3 is the true cancer precursor and that it should be the sole target of screening.

OBG Management: Do you think screening should be more frequent than the guidelines recommend?

Dr. Lonky: No, less screening is still safe—the extra cancer burden will be marginal, and some women who are not going to develop cervical cancer will be found to have CIN and treated unnecessarily. I think the common-sense response is: If we can prevent the same number of cancers with less use of screening resources and colposcopy, that is a good thing. We can use the savings to reach out to more women and increase the screening rate overall in the unscreened and under-screened populations.

OBG Management: Do you think the new guidelines fully address the issue of preventing cervical cancer?

Dr. Lonky: No, I don’t. What bothers me terribly is the fact that the focus is more on the resources and not on the cancer rate. We had wanted to address that rate with vaccination, but, due to low utilization of the vaccine, that strategy is unlikely to eradicate cervical cancer.

Until we create a therapy that is effective in altering the natural history of all CIN in any grade that it is detected, we will be unable to eradicate cervical cancer. Early CIN or HPV infection should be the target. Regrettably, research on an effective therapy is only beginning, and liberal, inappropriate use of destructive therapies increases the harms of finding early disease—and, therefore, the harms far exceed the benefits. The presumption that we can detect and treat CIN 3 just before it invades is woefully inadequate as a “screening” or “secondary prevention” strategy. We need to put more effort into finding an effective topical or oral therapy that will reverse the neoplastic progression of CIN 1+. If we had that, we could target early HPV infection or CIN 1 instead of CIN 3.

OBG Management: What do you make of the fact that about 50% of the cervical cancers that are diagnosed in the United States occur in women who have never been screened—and another 10% occur in women who have not been screened within the past 5 years?

Dr. Lonky: That means that 40% of the cancers in this country occur in women who are regularly screened—and the new guidelines do nothing to reduce that rate overall. If the argument is that society as a whole should re-invest the extra, ineffective dollars tied to screening women who are already well screened and shift those dollars to outreach to and screening of the under-screened or unscreened, I laud that, but I think that is an idealistic—not realistic—goal. Health care delivery and health- seeking behavior are tied to so many variables, such as insurance and employment, that this public health care goal cannot be guaranteed or the money easily redistributed. With these new guidelines, the overall cost of screening for cervical cancer should decrease, with little or no loss in effectiveness to prevent cervical cancer. Our next job is to find the better screening method or strategy and migrate to it, to lower the cancer rate.

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

We want to hear from you! Tell us what you think.

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

New guidelines are unlikely to lower the incidence of cervical cancer

What is the likely overall impact of new guidelines recommending less screening for cervical cancer?

We put this question—and others—to public health expert Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California–Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky serves as an OBG Management contributing editor. His responses offer a thoughtful commentary on the pressing issue of reducing the rate of cervical cancer in the United States.

“We have no evidence that any screening strategy will lower the cancer rate with any combination of cytology innovation or HPV test innovation,” he says. “These guidelines purely focus on ‘holding the gains’ on the current cancer incidence in the United States.”

OBG Management: Could you elaborate?

Dr. Lonky: The guidelines ask, “Are we wasting money?” and “Are we putting more women at risk with frequent testing?” They also go on to suggest that extra screening is prone to false-positive work-ups. They state that only CIN 3 is the true cancer precursor and that it should be the sole target of screening.

OBG Management: Do you think screening should be more frequent than the guidelines recommend?

Dr. Lonky: No, less screening is still safe—the extra cancer burden will be marginal, and some women who are not going to develop cervical cancer will be found to have CIN and treated unnecessarily. I think the common-sense response is: If we can prevent the same number of cancers with less use of screening resources and colposcopy, that is a good thing. We can use the savings to reach out to more women and increase the screening rate overall in the unscreened and under-screened populations.

OBG Management: Do you think the new guidelines fully address the issue of preventing cervical cancer?

Dr. Lonky: No, I don’t. What bothers me terribly is the fact that the focus is more on the resources and not on the cancer rate. We had wanted to address that rate with vaccination, but, due to low utilization of the vaccine, that strategy is unlikely to eradicate cervical cancer.

Until we create a therapy that is effective in altering the natural history of all CIN in any grade that it is detected, we will be unable to eradicate cervical cancer. Early CIN or HPV infection should be the target. Regrettably, research on an effective therapy is only beginning, and liberal, inappropriate use of destructive therapies increases the harms of finding early disease—and, therefore, the harms far exceed the benefits. The presumption that we can detect and treat CIN 3 just before it invades is woefully inadequate as a “screening” or “secondary prevention” strategy. We need to put more effort into finding an effective topical or oral therapy that will reverse the neoplastic progression of CIN 1+. If we had that, we could target early HPV infection or CIN 1 instead of CIN 3.

OBG Management: What do you make of the fact that about 50% of the cervical cancers that are diagnosed in the United States occur in women who have never been screened—and another 10% occur in women who have not been screened within the past 5 years?

Dr. Lonky: That means that 40% of the cancers in this country occur in women who are regularly screened—and the new guidelines do nothing to reduce that rate overall. If the argument is that society as a whole should re-invest the extra, ineffective dollars tied to screening women who are already well screened and shift those dollars to outreach to and screening of the under-screened or unscreened, I laud that, but I think that is an idealistic—not realistic—goal. Health care delivery and health- seeking behavior are tied to so many variables, such as insurance and employment, that this public health care goal cannot be guaranteed or the money easily redistributed. With these new guidelines, the overall cost of screening for cervical cancer should decrease, with little or no loss in effectiveness to prevent cervical cancer. Our next job is to find the better screening method or strategy and migrate to it, to lower the cancer rate.

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

We want to hear from you! Tell us what you think.

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

New guidelines are unlikely to lower the incidence of cervical cancer

What is the likely overall impact of new guidelines recommending less screening for cervical cancer?

We put this question—and others—to public health expert Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California–Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky serves as an OBG Management contributing editor. His responses offer a thoughtful commentary on the pressing issue of reducing the rate of cervical cancer in the United States.

“We have no evidence that any screening strategy will lower the cancer rate with any combination of cytology innovation or HPV test innovation,” he says. “These guidelines purely focus on ‘holding the gains’ on the current cancer incidence in the United States.”

OBG Management: Could you elaborate?

Dr. Lonky: The guidelines ask, “Are we wasting money?” and “Are we putting more women at risk with frequent testing?” They also go on to suggest that extra screening is prone to false-positive work-ups. They state that only CIN 3 is the true cancer precursor and that it should be the sole target of screening.

OBG Management: Do you think screening should be more frequent than the guidelines recommend?

Dr. Lonky: No, less screening is still safe—the extra cancer burden will be marginal, and some women who are not going to develop cervical cancer will be found to have CIN and treated unnecessarily. I think the common-sense response is: If we can prevent the same number of cancers with less use of screening resources and colposcopy, that is a good thing. We can use the savings to reach out to more women and increase the screening rate overall in the unscreened and under-screened populations.

OBG Management: Do you think the new guidelines fully address the issue of preventing cervical cancer?

Dr. Lonky: No, I don’t. What bothers me terribly is the fact that the focus is more on the resources and not on the cancer rate. We had wanted to address that rate with vaccination, but, due to low utilization of the vaccine, that strategy is unlikely to eradicate cervical cancer.

Until we create a therapy that is effective in altering the natural history of all CIN in any grade that it is detected, we will be unable to eradicate cervical cancer. Early CIN or HPV infection should be the target. Regrettably, research on an effective therapy is only beginning, and liberal, inappropriate use of destructive therapies increases the harms of finding early disease—and, therefore, the harms far exceed the benefits. The presumption that we can detect and treat CIN 3 just before it invades is woefully inadequate as a “screening” or “secondary prevention” strategy. We need to put more effort into finding an effective topical or oral therapy that will reverse the neoplastic progression of CIN 1+. If we had that, we could target early HPV infection or CIN 1 instead of CIN 3.

OBG Management: What do you make of the fact that about 50% of the cervical cancers that are diagnosed in the United States occur in women who have never been screened—and another 10% occur in women who have not been screened within the past 5 years?

Dr. Lonky: That means that 40% of the cancers in this country occur in women who are regularly screened—and the new guidelines do nothing to reduce that rate overall. If the argument is that society as a whole should re-invest the extra, ineffective dollars tied to screening women who are already well screened and shift those dollars to outreach to and screening of the under-screened or unscreened, I laud that, but I think that is an idealistic—not realistic—goal. Health care delivery and health- seeking behavior are tied to so many variables, such as insurance and employment, that this public health care goal cannot be guaranteed or the money easily redistributed. With these new guidelines, the overall cost of screening for cervical cancer should decrease, with little or no loss in effectiveness to prevent cervical cancer. Our next job is to find the better screening method or strategy and migrate to it, to lower the cancer rate.

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

We want to hear from you! Tell us what you think.

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

Several small studies have suggested that endometriosis—which affects about 10% of women of reproductive age—is a risk factor for epithelial ovarian cancer. Now, a study published online in Lancet Oncology provides definitive evidence of this link and highlights the risk of specific subtypes of ovarian cancer.¹

In the study, a team from the Ovarian Cancer Association Consortium calculated the size of the association between endometriosis and each of the five major ovarian cancer histologic subtypes:

• high-grade serous (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.97–1.32; P = .13)
• low-grade serous (OR, 2.11; 95% CI, 1.39–3.20; P < .0001)
• clear-cell (OR, 3.05; 95% CI, 2.43–3.84; P < .0001)
• endometrioid (OR, 2.04; 95% CI, 1.67–2.48; P < .0001)
• mucinous carcinomas (OR, 1.02; 95% CI, 0.69–1.50; P = .93).

The study consisted of a pooled analysis of 13 case-control studies, which included data from more than 23,000 women (13,326 controls; 7,911 women who had invasive ovarian cancer; and 1,907 women who had borderline cancer).

A history of endometriosis more than tripled the risk of clear-cell ovarian cancer and more than doubled the risk of endometrioid tumors. It also doubled the risk of low-grade serous ovarian cancers.

A link was not found between endometriosis and high-grade serous, mucinous, serous borderline, or mucinous borderline ovarian cancers.

The authors of the published report of the study characterize their findings as a “breakthrough” that “could lead to better identification of women at increased risk of ovarian cancer and could provide a basis for increased cancer surveillance of the relevant population, allowing better individualization of prevention and early detection approaches such as risk-reduction surgery and screening,” according to Celeste Leigh Pearce from the University of Southern California, Los Angeles, the lead author.

But the authors were quick to offer a caution: “Although we have reported strong associations between endometriosis and risk of clear-cell, endometrioid, and low-grade serous ovarian cancers, most women with endometriosis do not develop ovarian cancer. However, health-care providers should be alert to the increased risk of specific subtypes of ovarian cancer in women with a history of endometriosis.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

A study of antiviral therapy to treat herpes simplex virus type 2 (HSV-2) demonstrated that the virus can reactivate in “breakthrough episodes” even when doses of antiviral therapy are high.

The study, published last month in The Lancet, combined three trials:

• In Trial 1, participants were randomized to standard-dose aciclovir (Zovirax, Zovir, etc.) (400 mg twice daily) or no medication for 4 weeks, followed by a 1-week wash-out period and crossover to the opposite group for another 4 weeks.
• In Trial 2, participants were randomized to standard-dose valaciclovir (Valtrex) (500 mg daily) or high-dose aciclovir (800 mg three times daily) for 7 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 7 additional weeks.
• In Trial 3, subjects were randomized to standard-dose valaciclovir or high-dose valaciclovir (1 g three times daily) for 5 weeks, followed by a 1-week wash-out period and crossover to the opposite group for 5 additional weeks.¹

All three trials demonstrated that short episodes of subclinical shedding persist with both standard-dose and high-dose aciclovir and valaciclovir. Although shedding of HSV-2 decreased 50% in participants who took the highest dose of valaciclovir, compared with standard-dose valaciclovir, the rate of breakthrough shedding did not change—about 16 to 20 episodes every year.

“Despite the increased use of antiviral therapy in the past two decades,” the authors observe, “the prevalence of, and complications from, HSV-2 infection have changed little.”

“Daily antiviral therapy,” they go on to say, “reduces genital lesions and suppresses detection of HSV on genital mucosal surfaces (shedding),” but daily valaciclovir reduces the risk of sexual transmission by only 48%. Furthermore, aciclovir does not reduce the risk of HIV transmission or acquisition, which is heightened in people who have HSV-2.

“The discrepancy between potent suppression of clinical symptoms and failure of antiviral agents to fully prevent HSV transmission is not well understood. Intensive genital secretion collection shows that HSV shedding episodes are three times more frequent than was previously realized.”

We want to hear from you! Tell us what you think.

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The final results of the Population-Based Screening Study Amsterdam (POBASCAM), published online in The Lancet Oncology, provide the strongest evidence to date in support of HPV testing as a cervical cancer screening strategy, according to Rijkaart and colleagues, authors of the study.¹

The POBASCAM trial involved nearly 45,000 women 29 to 56 years old who attended routine cervical screening in the Netherlands. Investigators examined whether HPV testing was associated with fewer high-grade cervical lesions and cervical cancer in the second round of screening because of earlier detection and treatment of lesions. They also sought to determine the most appropriate age to initiate HPV testing.

At the start of the study, women were randomly assigned to cotesting with HPV DNA and Pap testing or to cytology alone. At the second screening round 5 years later, HPV and cytology testing were performed on all women.

In the first screen, the arm that included HPV testing identified significantly more cancer precursors (cervical intraepithelial neoplasia [CIN] grade 2 or worse) than cytology alone. Five years later, significantly fewer women had CIN 3 or worse and cervical cancer in the HPV group than in the group that underwent cytology alone (88 of 19,579 women in the HPV group vs 122 of 19,731 women in the control group [relative risk, 0.73; 95% confidence interval (CI), 0.55–0.96; P=.023]). Cervical cancer was also less common in the HPV group than in the control group (4 of 19,579 women in the HPV group vs 14 of 19,731 women in the control group [relative risk, 0.29; 95% CI, 0.10–0.87; P=.031]).

“Implementation of HPV DNA testing in cervical screening leads to earlier detection of clinically relevant CIN grade 2 or worse, which, when adequately treated, improves protection against CIN grade 3 or worse and cervical cancer,” the investigators concluded.

Improved protection against CIN 3 and worse in the HPV group was largely due to early detection of high-grade cervical lesions caused by HPV 16, which, along with HPV 18, is responsible for more than 70% of cervical cancers. This finding indicates that HPV testing could, eventually, lead to a reduction in the rate of cancer-related illness and death.

When data from both screening rounds were combined, the cumulative detection of CIN 2+ and CIN 3+ did not differ between women 29 to 33 years old and women older than 33 years, indicating that HPV testing did not lead to overdiagnosis of regressive CIN 2+ lesions in younger women.

“Our results…lend support to the implementation of HPV DNA testing in programmed cervical screening starting at age 30 years,” the investigators write.

The authors of an accompanying commentary observe that the “POBASCAM trial shows that 5-year screening intervals are safe, and that conservative management of HPV-positive women can control excess CIN grade 2 or 3 while preventing cervical cancer. However, how the POBASCAM protocol would perform in other populations that have different baseline cancer rates, compliance, and management infrastructure, is unclear.”²

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.

The birth rate among US teens 15 to 19 years old was 34.3 births for every 1,000 teenagers in 2010—a 9% decline from 2009 and the lowest rate ever recorded in nearly seven decades of collecting data, according to a report released November 17, 2011, by the Centers for Disease Control and Prevention (CDC).

The report, Births: Preliminary Data for 2010, from the CDC’s National Center for Health Statistics, is based on an analysis of nearly 100% of birth records collected in the 50 states, the District of Columbia, and US territories.

The birth rate for teenagers 15 to 19 years old has declined for the past 3 years and 17 of the past 19 years. Birth rates for younger and older teenagers and for all race and ethnic groups reached historic lows in 2010.

Other findings:

• The rate of cesarean delivery declined for the first time since 1996. In 2010, it was 32.8%, down from 32.9% in 2009
• Total births declined 3%, from 4,130,665 in 2009 to 4,000,279 in 2010
• The overall fertility rate fell 3%, from 66.2 births for every 1,000 females 15 to 44 years old in 2009 to 64.1 in 2010. This is the third straight decline for overall fertility in the United States.
• The total number of births to unmarried mothers declined for the second year in a row, to 1,633,785, down from 1,693,685 in 2009. Similarly, the birth rate for unmarried mothers declined to 47.7 for every 1,000 women in 2010, compared with 49.9 in 2009. The percentage of births to unmarried mothers also declined slightly in 2010, to 40.8%, compared with 41% in 2009.
• The birth rate for women in their early 20s fell 6% in 2010. The rates also fell for women in their late 20s and 30s. However, the birth rate for women in their early 40s increased to 10.2 per 1,000 women in 2010, compared with 10.0 in 2009, making it the highest birth rate for this age group since 1967
• The preterm birth rate declined for the fourth straight year in 2010, to just under 12% of all births (11.99%)—a 6% drop from 2006
• The rate of low birth-weight infants remained essentially unchanged between 2009 and 2010 at less than 8.2%, but is down slightly from the record high of 8.3 in 2006.

The full report is available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf.

We want to hear from you! Tell us what you think.