Alicia Ault

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

ASHEVILLE, N.C. — The potential pitfalls around conception and childbirth can be daunting—and more so in women over age 35—but the physician can help ensure better outcomes by addressing concerns head-on and being supportive, said Dr. James E. Ferguson II at the Southern Obstetric and Gynecologic Seminar.

Patients would be better served if physicians approached the situation with optimism rather than pessimism, despite increasing odds against successful conception and complication-free childbirth as women age, he said.

It's no secret that pregnancies are being delayed, said Dr. Ferguson, chairman of the obstetrics and gynecology department at the University of Kentucky.

Data on older mothers generally show that postpartum and intrapartum complications—such as obstructed labor, prolonged labor, preeclampsia, and prematurity—are much higher in women over age 40, compared with those aged 20–29, he said.

But there are some contradictions. For instance, the First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER) study, conducted from 1999 to 2002, found no difference in gestational hypertension or preeclampsia between the under- and over-35 groups (Obstet. Gynecol. 2005;105:983–90). One caveat: The study population was mostly healthy, wealthy, and white, said Dr. Ferguson. The risk of spontaneous abortion was higher in the over-40 group, as were chromosomal abnormalities, low birth weight, and perinatal loss.

The likelihood of both maternal and fetal death also increases with age, Dr. Ferguson noted. But it doesn't have to be all bad news, he said. For instance, a mid-1990s study found that there were 4 fetal deaths per 1,000 live births in 34-year-old mothers, compared with 6–9 per 1,000 in 39-year-old mothers (N. Engl. J. Med. 1995;333:1,002–4). Viewed from an individual's perspective, those aren't such bad odds, said Dr. Ferguson. “I personally find this very reassuring rather than very frightening,” he said.

Similarly, though maternal deaths increase significantly after age 39, the rate per 100,000 live births overall is still fairly low, said Dr. Ferguson. Compared with 25- to 29-year-olds, the relative risk of death is 2.3 for the 35- to 39-year-olds and 5.0 for women over 40, according to one study (Obstet. Gynecol. 2003;101:1,015–21). “It's much less significant than it is in the patient's mind,” he said, adding, “You can reassure her.”

Causes of death include pulmonary embolism, pregnancy-induced hypertension, and hemorrhage, either related or not related to ectopic pregnancy. Women over age 40 are at risk because of increased incidence of underlying medical conditions, more postpartum complications, and a higher likelihood of cesarean section. There have been few studies in women over 45, but the few conducted have shown that about half the pregnancies involved complications, and that the risk was much greater for first-time mothers.

Because of the common tendency to put off childbearing—and because almost half of pregnancies are unintended—gynecologists might consider treating every patient office visit as a preconception visit, said Dr. Ferguson.

Patients should be quizzed about medical and immunization histories, and counseled on risks and genetic testing. Physicians should also offer help with reducing risky behavior like smoking and alcohol use.

Women should also be made aware of the latest research on birth spacing—a child born less than 18 months or more than 50 months after the previous birth has a greater risk of bad perinatal outcome, he noted (JAMA 2006;295:1809–23).

For the older mother, “there are some special risks, but I think they are manageable,” Dr. Ferguson said.

ASHEVILLE, N.C. — The potential pitfalls around conception and childbirth can be daunting—and more so in women over age 35—but the physician can help ensure better outcomes by addressing concerns head-on and being supportive, said Dr. James E. Ferguson II at the Southern Obstetric and Gynecologic Seminar.

Patients would be better served if physicians approached the situation with optimism rather than pessimism, despite increasing odds against successful conception and complication-free childbirth as women age, he said.

It's no secret that pregnancies are being delayed, said Dr. Ferguson, chairman of the obstetrics and gynecology department at the University of Kentucky.

Data on older mothers generally show that postpartum and intrapartum complications—such as obstructed labor, prolonged labor, preeclampsia, and prematurity—are much higher in women over age 40, compared with those aged 20–29, he said.

But there are some contradictions. For instance, the First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER) study, conducted from 1999 to 2002, found no difference in gestational hypertension or preeclampsia between the under- and over-35 groups (Obstet. Gynecol. 2005;105:983–90). One caveat: The study population was mostly healthy, wealthy, and white, said Dr. Ferguson. The risk of spontaneous abortion was higher in the over-40 group, as were chromosomal abnormalities, low birth weight, and perinatal loss.

The likelihood of both maternal and fetal death also increases with age, Dr. Ferguson noted. But it doesn't have to be all bad news, he said. For instance, a mid-1990s study found that there were 4 fetal deaths per 1,000 live births in 34-year-old mothers, compared with 6–9 per 1,000 in 39-year-old mothers (N. Engl. J. Med. 1995;333:1,002–4). Viewed from an individual's perspective, those aren't such bad odds, said Dr. Ferguson. “I personally find this very reassuring rather than very frightening,” he said.

Similarly, though maternal deaths increase significantly after age 39, the rate per 100,000 live births overall is still fairly low, said Dr. Ferguson. Compared with 25- to 29-year-olds, the relative risk of death is 2.3 for the 35- to 39-year-olds and 5.0 for women over 40, according to one study (Obstet. Gynecol. 2003;101:1,015–21). “It's much less significant than it is in the patient's mind,” he said, adding, “You can reassure her.”

Causes of death include pulmonary embolism, pregnancy-induced hypertension, and hemorrhage, either related or not related to ectopic pregnancy. Women over age 40 are at risk because of increased incidence of underlying medical conditions, more postpartum complications, and a higher likelihood of cesarean section. There have been few studies in women over 45, but the few conducted have shown that about half the pregnancies involved complications, and that the risk was much greater for first-time mothers.

Because of the common tendency to put off childbearing—and because almost half of pregnancies are unintended—gynecologists might consider treating every patient office visit as a preconception visit, said Dr. Ferguson.

Patients should be quizzed about medical and immunization histories, and counseled on risks and genetic testing. Physicians should also offer help with reducing risky behavior like smoking and alcohol use.

Women should also be made aware of the latest research on birth spacing—a child born less than 18 months or more than 50 months after the previous birth has a greater risk of bad perinatal outcome, he noted (JAMA 2006;295:1809–23).

For the older mother, “there are some special risks, but I think they are manageable,” Dr. Ferguson said.

ASHEVILLE, N.C. — The potential pitfalls around conception and childbirth can be daunting—and more so in women over age 35—but the physician can help ensure better outcomes by addressing concerns head-on and being supportive, said Dr. James E. Ferguson II at the Southern Obstetric and Gynecologic Seminar.

Patients would be better served if physicians approached the situation with optimism rather than pessimism, despite increasing odds against successful conception and complication-free childbirth as women age, he said.

It's no secret that pregnancies are being delayed, said Dr. Ferguson, chairman of the obstetrics and gynecology department at the University of Kentucky.

Data on older mothers generally show that postpartum and intrapartum complications—such as obstructed labor, prolonged labor, preeclampsia, and prematurity—are much higher in women over age 40, compared with those aged 20–29, he said.

But there are some contradictions. For instance, the First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER) study, conducted from 1999 to 2002, found no difference in gestational hypertension or preeclampsia between the under- and over-35 groups (Obstet. Gynecol. 2005;105:983–90). One caveat: The study population was mostly healthy, wealthy, and white, said Dr. Ferguson. The risk of spontaneous abortion was higher in the over-40 group, as were chromosomal abnormalities, low birth weight, and perinatal loss.

The likelihood of both maternal and fetal death also increases with age, Dr. Ferguson noted. But it doesn't have to be all bad news, he said. For instance, a mid-1990s study found that there were 4 fetal deaths per 1,000 live births in 34-year-old mothers, compared with 6–9 per 1,000 in 39-year-old mothers (N. Engl. J. Med. 1995;333:1,002–4). Viewed from an individual's perspective, those aren't such bad odds, said Dr. Ferguson. “I personally find this very reassuring rather than very frightening,” he said.

Similarly, though maternal deaths increase significantly after age 39, the rate per 100,000 live births overall is still fairly low, said Dr. Ferguson. Compared with 25- to 29-year-olds, the relative risk of death is 2.3 for the 35- to 39-year-olds and 5.0 for women over 40, according to one study (Obstet. Gynecol. 2003;101:1,015–21). “It's much less significant than it is in the patient's mind,” he said, adding, “You can reassure her.”

Causes of death include pulmonary embolism, pregnancy-induced hypertension, and hemorrhage, either related or not related to ectopic pregnancy. Women over age 40 are at risk because of increased incidence of underlying medical conditions, more postpartum complications, and a higher likelihood of cesarean section. There have been few studies in women over 45, but the few conducted have shown that about half the pregnancies involved complications, and that the risk was much greater for first-time mothers.

Because of the common tendency to put off childbearing—and because almost half of pregnancies are unintended—gynecologists might consider treating every patient office visit as a preconception visit, said Dr. Ferguson.

Patients should be quizzed about medical and immunization histories, and counseled on risks and genetic testing. Physicians should also offer help with reducing risky behavior like smoking and alcohol use.

Women should also be made aware of the latest research on birth spacing—a child born less than 18 months or more than 50 months after the previous birth has a greater risk of bad perinatal outcome, he noted (JAMA 2006;295:1809–23).

For the older mother, “there are some special risks, but I think they are manageable,” Dr. Ferguson said.

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, said Dr. Angela Gantt, who spoke here at the Southern Obstetric and Gynecologic Seminar.

Thanks to a burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt, of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

“If you feel something abnormal, ultrasound helps you determine what course to take,” she said. According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, said Dr. Gantt.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and paraovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, said Dr. Gantt. Generally, these cysts are observed. For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women, she said.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, said Dr. Gantt. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity.

The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, said Dr. Gantt. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be very dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow—as shown by Doppler—is extremely abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, said Dr. Angela Gantt, who spoke here at the Southern Obstetric and Gynecologic Seminar.

Thanks to a burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt, of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

“If you feel something abnormal, ultrasound helps you determine what course to take,” she said. According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, said Dr. Gantt.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and paraovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, said Dr. Gantt. Generally, these cysts are observed. For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women, she said.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, said Dr. Gantt. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity.

The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, said Dr. Gantt. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be very dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow—as shown by Doppler—is extremely abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, said Dr. Angela Gantt, who spoke here at the Southern Obstetric and Gynecologic Seminar.

Thanks to a burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt, of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.

“If you feel something abnormal, ultrasound helps you determine what course to take,” she said. According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, said Dr. Gantt.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and paraovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, said Dr. Gantt. Generally, these cysts are observed. For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women, she said.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, said Dr. Gantt. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity.

The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, said Dr. Gantt. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be very dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow—as shown by Doppler—is extremely abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that the FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown.

The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School, Madison.

Among the panel's other recommendations:

PIFDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board.

“We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that the FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown.

The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School, Madison.

Among the panel's other recommendations:

PIFDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board.

“We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Numerous safety-related issues over the past few years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that the FDA should consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown.

The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, said the committee.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, said the panel.

In addition, results of any phase II-IV clinical trials that are submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Given that most label changes are voluntary and that many companies have not conducted the requested postmarketing studies, the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said.

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School, Madison.

Among the panel's other recommendations:

PIFDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” said acting FDA Commissioner Andrew von Eschenbach at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board.

“We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

Carotid Registry Opened

The Carotid Artery Revascularization and Endarterectomy (CARE) Registry, developed by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, is open for business. As with other components of the National Cardiovascular Data Registry (NCDR), hospitals that participate will be meeting data collection requirements for Medicare payment. Data can even be retrospectively collected, going back to March 2005. Categories include device and lesion characteristics; adverse event rates, including 30-day outcomes; and patient, provider, and facility characteristics. Currently, data can be collected on paper and submitted via a complimentary data entry service offered by the registry. Beginning in January 2007, data can be submitted online at a new NCDR Web site. Participants will receive quarterly and annual benchmark reports that will give data such as comparisons between stent and endarterectomy complications, and the relative outcomes within the registry population.

CMS Incentive Payment Demo

The Center for Medicare and Medicaid Services is seeking participants for a 3-year demonstration project beginning in 2007 in which hospitals would offer incentive payments to physicians for improved quality and efficiency. CMS said it would give preference to consortiums consisting of up to 12 physician groups and their affiliated hospitals in a single geographically contiguous area. The Physician-Hospital Collaboration Demonstration will be extended to only 72 hospitals total, said CMS. The agency is looking for long-term outcomes such as mortality and readmission rates. Participants must document an episode of care from hospitalization to postdischarge and beyond. Hospitals would, for instance, offer incentive payments to surgeons for lower infection rates and fewer readmissions with complications, said CMS. Those payments would be limited to 25% of the normal pay for those cases. To apply, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/

FDA Advisers: Pushovers?

A report by the Washington-based National Research Center for Women and Families claims that the Food and Drug Administration's outside advisers are pushovers when it comes to challenging drug and device applications. They analyzed voting records of a random sample of six drug advisory panels and five medical device panels from 1998 to 2005, and found a 76% approval rate for new drugs and 82% rate for new devices. The FDA does not have to follow the experts' advice, but it generally does. Of the 38 drugs recommended, all were approved by the FDA except one whose application was withdrawn by the manufacturer. The agency also approved 4 of the 11 drugs that received a negative vote. Only 50% of the reproductive health drugs were backed, compared with 100% of the products that came before the arthritis drugs advisory committee. Sixty-seven percent of microbiology devices were backed, as were 88% of ophthalmic devices. After reviewing transcripts, the researchers found that advisory panel members often expressed strong concerns about safety or efficacy, but voted to recommend approval anyway. Some committee members admitted that their votes may not have been consistent with their concerns. “Whatever the reasons, many of today's FDA drug and device advisory committees are rubber stamps for approval almost every time they meet,” wrote the researchers.

Merck Executives Exonerated

Retired U.S. District Court Judge John S. Martin Jr. has determined that Merck & Co.'s executives did not knowingly mislead consumers or physicians on the cardiovascular safety of its cyclo-oxygenase-2 inhibitor, Vioxx. The judge was hired by Merck's board of directors. Over 20 months, Judge Martin and his staff reviewed the scientific literature and documents submitted in some 14,000 personal injury suits and interviewed 115 witnesses, including 100 former and present Merck employees. After talking with senior scientists, the judge said, “We are satisfied that, prior to receiving the cardiovascular results of the APPROVe trial, none of them believed that Vioxx was prothrombotic.” The scientists urged that Vioxx be promptly withdrawn, which the company did, despite contrary advice from outside advisers, said the report. “This conduct is not consistent with the view that Merck's corporate culture put profits over patient safety,” wrote the judge. Merck's board issued a statement that it “is reassured by the fact that, in reviewing numerous allegations of wrongdoing, the Martin Report concludes that management acted with integrity and had legitimate reasons for making the decision that it made, in light of the knowledge available at the time.” The full report is available on Merck's Web site at

www.merck.com/newsroom/vioxx/

Carotid Registry Opened

The Carotid Artery Revascularization and Endarterectomy (CARE) Registry, developed by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, is open for business. As with other components of the National Cardiovascular Data Registry (NCDR), hospitals that participate will be meeting data collection requirements for Medicare payment. Data can even be retrospectively collected, going back to March 2005. Categories include device and lesion characteristics; adverse event rates, including 30-day outcomes; and patient, provider, and facility characteristics. Currently, data can be collected on paper and submitted via a complimentary data entry service offered by the registry. Beginning in January 2007, data can be submitted online at a new NCDR Web site. Participants will receive quarterly and annual benchmark reports that will give data such as comparisons between stent and endarterectomy complications, and the relative outcomes within the registry population.

CMS Incentive Payment Demo

The Center for Medicare and Medicaid Services is seeking participants for a 3-year demonstration project beginning in 2007 in which hospitals would offer incentive payments to physicians for improved quality and efficiency. CMS said it would give preference to consortiums consisting of up to 12 physician groups and their affiliated hospitals in a single geographically contiguous area. The Physician-Hospital Collaboration Demonstration will be extended to only 72 hospitals total, said CMS. The agency is looking for long-term outcomes such as mortality and readmission rates. Participants must document an episode of care from hospitalization to postdischarge and beyond. Hospitals would, for instance, offer incentive payments to surgeons for lower infection rates and fewer readmissions with complications, said CMS. Those payments would be limited to 25% of the normal pay for those cases. To apply, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/

FDA Advisers: Pushovers?

A report by the Washington-based National Research Center for Women and Families claims that the Food and Drug Administration's outside advisers are pushovers when it comes to challenging drug and device applications. They analyzed voting records of a random sample of six drug advisory panels and five medical device panels from 1998 to 2005, and found a 76% approval rate for new drugs and 82% rate for new devices. The FDA does not have to follow the experts' advice, but it generally does. Of the 38 drugs recommended, all were approved by the FDA except one whose application was withdrawn by the manufacturer. The agency also approved 4 of the 11 drugs that received a negative vote. Only 50% of the reproductive health drugs were backed, compared with 100% of the products that came before the arthritis drugs advisory committee. Sixty-seven percent of microbiology devices were backed, as were 88% of ophthalmic devices. After reviewing transcripts, the researchers found that advisory panel members often expressed strong concerns about safety or efficacy, but voted to recommend approval anyway. Some committee members admitted that their votes may not have been consistent with their concerns. “Whatever the reasons, many of today's FDA drug and device advisory committees are rubber stamps for approval almost every time they meet,” wrote the researchers.

Merck Executives Exonerated

Retired U.S. District Court Judge John S. Martin Jr. has determined that Merck & Co.'s executives did not knowingly mislead consumers or physicians on the cardiovascular safety of its cyclo-oxygenase-2 inhibitor, Vioxx. The judge was hired by Merck's board of directors. Over 20 months, Judge Martin and his staff reviewed the scientific literature and documents submitted in some 14,000 personal injury suits and interviewed 115 witnesses, including 100 former and present Merck employees. After talking with senior scientists, the judge said, “We are satisfied that, prior to receiving the cardiovascular results of the APPROVe trial, none of them believed that Vioxx was prothrombotic.” The scientists urged that Vioxx be promptly withdrawn, which the company did, despite contrary advice from outside advisers, said the report. “This conduct is not consistent with the view that Merck's corporate culture put profits over patient safety,” wrote the judge. Merck's board issued a statement that it “is reassured by the fact that, in reviewing numerous allegations of wrongdoing, the Martin Report concludes that management acted with integrity and had legitimate reasons for making the decision that it made, in light of the knowledge available at the time.” The full report is available on Merck's Web site at

www.merck.com/newsroom/vioxx/

Carotid Registry Opened

The Carotid Artery Revascularization and Endarterectomy (CARE) Registry, developed by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions, is open for business. As with other components of the National Cardiovascular Data Registry (NCDR), hospitals that participate will be meeting data collection requirements for Medicare payment. Data can even be retrospectively collected, going back to March 2005. Categories include device and lesion characteristics; adverse event rates, including 30-day outcomes; and patient, provider, and facility characteristics. Currently, data can be collected on paper and submitted via a complimentary data entry service offered by the registry. Beginning in January 2007, data can be submitted online at a new NCDR Web site. Participants will receive quarterly and annual benchmark reports that will give data such as comparisons between stent and endarterectomy complications, and the relative outcomes within the registry population.

CMS Incentive Payment Demo

The Center for Medicare and Medicaid Services is seeking participants for a 3-year demonstration project beginning in 2007 in which hospitals would offer incentive payments to physicians for improved quality and efficiency. CMS said it would give preference to consortiums consisting of up to 12 physician groups and their affiliated hospitals in a single geographically contiguous area. The Physician-Hospital Collaboration Demonstration will be extended to only 72 hospitals total, said CMS. The agency is looking for long-term outcomes such as mortality and readmission rates. Participants must document an episode of care from hospitalization to postdischarge and beyond. Hospitals would, for instance, offer incentive payments to surgeons for lower infection rates and fewer readmissions with complications, said CMS. Those payments would be limited to 25% of the normal pay for those cases. To apply, go to

www.cms.hhs.gov/DemoProjectsEvalRpts/

FDA Advisers: Pushovers?

A report by the Washington-based National Research Center for Women and Families claims that the Food and Drug Administration's outside advisers are pushovers when it comes to challenging drug and device applications. They analyzed voting records of a random sample of six drug advisory panels and five medical device panels from 1998 to 2005, and found a 76% approval rate for new drugs and 82% rate for new devices. The FDA does not have to follow the experts' advice, but it generally does. Of the 38 drugs recommended, all were approved by the FDA except one whose application was withdrawn by the manufacturer. The agency also approved 4 of the 11 drugs that received a negative vote. Only 50% of the reproductive health drugs were backed, compared with 100% of the products that came before the arthritis drugs advisory committee. Sixty-seven percent of microbiology devices were backed, as were 88% of ophthalmic devices. After reviewing transcripts, the researchers found that advisory panel members often expressed strong concerns about safety or efficacy, but voted to recommend approval anyway. Some committee members admitted that their votes may not have been consistent with their concerns. “Whatever the reasons, many of today's FDA drug and device advisory committees are rubber stamps for approval almost every time they meet,” wrote the researchers.

Merck Executives Exonerated

Retired U.S. District Court Judge John S. Martin Jr. has determined that Merck & Co.'s executives did not knowingly mislead consumers or physicians on the cardiovascular safety of its cyclo-oxygenase-2 inhibitor, Vioxx. The judge was hired by Merck's board of directors. Over 20 months, Judge Martin and his staff reviewed the scientific literature and documents submitted in some 14,000 personal injury suits and interviewed 115 witnesses, including 100 former and present Merck employees. After talking with senior scientists, the judge said, “We are satisfied that, prior to receiving the cardiovascular results of the APPROVe trial, none of them believed that Vioxx was prothrombotic.” The scientists urged that Vioxx be promptly withdrawn, which the company did, despite contrary advice from outside advisers, said the report. “This conduct is not consistent with the view that Merck's corporate culture put profits over patient safety,” wrote the judge. Merck's board issued a statement that it “is reassured by the fact that, in reviewing numerous allegations of wrongdoing, the Martin Report concludes that management acted with integrity and had legitimate reasons for making the decision that it made, in light of the knowledge available at the time.” The full report is available on Merck's Web site at

www.merck.com/newsroom/vioxx/

BETHESDA, MD. — Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States—leading to 440,000 deaths each year—and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing—and then enforcing—laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge.

The committee also stated that people with psychiatric conditions—especially schizophrenia and major depressive disorder—are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel. Its advice to tobacco users: “If at first you don't succeed, try, try again and get some help,” said panelist Dr. Christine Laine of Jefferson Medical College, Philadelphia.

Copies of the consensus statement can be found at http://consensus.nih.gov

BETHESDA, MD. — Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States—leading to 440,000 deaths each year—and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing—and then enforcing—laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge.

The committee also stated that people with psychiatric conditions—especially schizophrenia and major depressive disorder—are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel. Its advice to tobacco users: “If at first you don't succeed, try, try again and get some help,” said panelist Dr. Christine Laine of Jefferson Medical College, Philadelphia.

Copies of the consensus statement can be found at http://consensus.nih.gov

BETHESDA, MD. — Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States—leading to 440,000 deaths each year—and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing—and then enforcing—laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge.

The committee also stated that people with psychiatric conditions—especially schizophrenia and major depressive disorder—are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel. Its advice to tobacco users: “If at first you don't succeed, try, try again and get some help,” said panelist Dr. Christine Laine of Jefferson Medical College, Philadelphia.

Copies of the consensus statement can be found at http://consensus.nih.gov

The Food and Drug Administration has given a limited approval to the first totally artificial implantable heart, Abiomed Inc.'s AbioCor.

The AbioCor was approved under a humanitarian device exemption. Under an HDE, the device has to show a “probable benefit,” a less onerous standard than would be required under a premarket approval application, said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The approval limits use of the device to no more than 4,000 patients each year.

Both the FDA and Danvers, Mass.-based Abiomed expect there to be a very limited patient population. The $250,000 device is indicated in patients with severe right and left ventricular failure, who are not eligible for transplant and who have a life expectancy of less than 1 month. Patients also may have pulmonary hypertension refractory to pharmacologic management, significant aortic valve regurgitation, mechanical valve prosthesis, intractable life-threatening arrhythmias, ventricular septal rupture, or failed transplant.

Most likely, only men and larger women would be eligible to receive the 2-pound device.

In Abiomed's 14-patient study, patients were an average 6 feet tall and weighed 170–180 pounds, Dr. Bram Zuckerman, director of FDA's Division of Cardiovascular Devices, said in a briefing with reporters.

The AbioCor is the result of almost 30 years of research and development, much of which was supported by the National Heart, Lung, and Blood Institute.

“The approval of the totally implanted artificial heart is a significant milestone as there are few options for heart failure patients with the most severe form of the disease and who are in critical need,” the NHLBI's director, Dr. Elizabeth G. Nabel, said in a statement.

The implanted system consists of an artificial heart, a battery, and two controllers that receive information via radio waves from an external controller and power source. Patients can be away from a power source for up to 1 hour—an important quality-of-life consideration that influenced the FDA's approval decision, Dr. Zuckerman said.

In Abiomed's original study—in 14 patients from 2001 to 2004—6 of the 12 patients who survived surgery were ambulatory and 4 made excursions outside of the hospital. One patient was discharged to home. The mean life span on AbioCor was 5 months, but the range was 53–512 days.

“Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is, in the view of many patients and family members, a significant improvement in quality of life,” Dr. Zuckerman said.

The FDA approval comes despite a 7–6 vote against approval by an FDA advisory panel in June 2005. The committee had concerns about clotting and stroke risk.

After the first five patients were implanted and died, Abiomed conducted autopsies that led the company to slightly redesign the AbioCor, which was accepted by the FDA, said company chairman and CEO Michael R. Minogue in an interview. Anticoagulation continued to be a challenge in the next nine patients, however.

The company has learned that only patients who can tolerate anticoagulation therapy should receive the AbioCor, Mr. Minogue said. In a planned postapproval study, which will enroll all patients implanted with the device, the company will determine how to best manage patients and whether it can appropriately train surgeons at new clinical sites.

The first implants will occur at Jewish Hospital in Louisville, Ky., where Dr. Laman Gray, director of the division of thoracic and cardiovascular surgery at the University of Louisville, and Dr. Rob Dowling, director of the heart transplant and cardiac assist devices program at Jewish Hospital, have implanted 7 of the original 14 devices since 2001.

Both Johns Hopkins Hospital, in Baltimore, and the Robert Wood Johnson University Hospital, in New Brunswick, N.J., also have entered into letters of intent to implant the AbioCor. Mr. Minogue said he expects training at these facilities to take at least 8–10 months.

The company aims to bring 5–10 centers on line. The AbioCor 2 is currently in development. It will be 30% smaller, have a different pump system, and will last up to 5 years, Mr. Minogue said.

The Food and Drug Administration has given a limited approval to the first totally artificial implantable heart, Abiomed Inc.'s AbioCor.

The AbioCor was approved under a humanitarian device exemption. Under an HDE, the device has to show a “probable benefit,” a less onerous standard than would be required under a premarket approval application, said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The approval limits use of the device to no more than 4,000 patients each year.

Both the FDA and Danvers, Mass.-based Abiomed expect there to be a very limited patient population. The $250,000 device is indicated in patients with severe right and left ventricular failure, who are not eligible for transplant and who have a life expectancy of less than 1 month. Patients also may have pulmonary hypertension refractory to pharmacologic management, significant aortic valve regurgitation, mechanical valve prosthesis, intractable life-threatening arrhythmias, ventricular septal rupture, or failed transplant.

Most likely, only men and larger women would be eligible to receive the 2-pound device.

In Abiomed's 14-patient study, patients were an average 6 feet tall and weighed 170–180 pounds, Dr. Bram Zuckerman, director of FDA's Division of Cardiovascular Devices, said in a briefing with reporters.

The AbioCor is the result of almost 30 years of research and development, much of which was supported by the National Heart, Lung, and Blood Institute.

“The approval of the totally implanted artificial heart is a significant milestone as there are few options for heart failure patients with the most severe form of the disease and who are in critical need,” the NHLBI's director, Dr. Elizabeth G. Nabel, said in a statement.

The implanted system consists of an artificial heart, a battery, and two controllers that receive information via radio waves from an external controller and power source. Patients can be away from a power source for up to 1 hour—an important quality-of-life consideration that influenced the FDA's approval decision, Dr. Zuckerman said.

In Abiomed's original study—in 14 patients from 2001 to 2004—6 of the 12 patients who survived surgery were ambulatory and 4 made excursions outside of the hospital. One patient was discharged to home. The mean life span on AbioCor was 5 months, but the range was 53–512 days.

“Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is, in the view of many patients and family members, a significant improvement in quality of life,” Dr. Zuckerman said.

The FDA approval comes despite a 7–6 vote against approval by an FDA advisory panel in June 2005. The committee had concerns about clotting and stroke risk.

After the first five patients were implanted and died, Abiomed conducted autopsies that led the company to slightly redesign the AbioCor, which was accepted by the FDA, said company chairman and CEO Michael R. Minogue in an interview. Anticoagulation continued to be a challenge in the next nine patients, however.

The company has learned that only patients who can tolerate anticoagulation therapy should receive the AbioCor, Mr. Minogue said. In a planned postapproval study, which will enroll all patients implanted with the device, the company will determine how to best manage patients and whether it can appropriately train surgeons at new clinical sites.

The first implants will occur at Jewish Hospital in Louisville, Ky., where Dr. Laman Gray, director of the division of thoracic and cardiovascular surgery at the University of Louisville, and Dr. Rob Dowling, director of the heart transplant and cardiac assist devices program at Jewish Hospital, have implanted 7 of the original 14 devices since 2001.

Both Johns Hopkins Hospital, in Baltimore, and the Robert Wood Johnson University Hospital, in New Brunswick, N.J., also have entered into letters of intent to implant the AbioCor. Mr. Minogue said he expects training at these facilities to take at least 8–10 months.

The company aims to bring 5–10 centers on line. The AbioCor 2 is currently in development. It will be 30% smaller, have a different pump system, and will last up to 5 years, Mr. Minogue said.

The Food and Drug Administration has given a limited approval to the first totally artificial implantable heart, Abiomed Inc.'s AbioCor.

The AbioCor was approved under a humanitarian device exemption. Under an HDE, the device has to show a “probable benefit,” a less onerous standard than would be required under a premarket approval application, said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The approval limits use of the device to no more than 4,000 patients each year.

Both the FDA and Danvers, Mass.-based Abiomed expect there to be a very limited patient population. The $250,000 device is indicated in patients with severe right and left ventricular failure, who are not eligible for transplant and who have a life expectancy of less than 1 month. Patients also may have pulmonary hypertension refractory to pharmacologic management, significant aortic valve regurgitation, mechanical valve prosthesis, intractable life-threatening arrhythmias, ventricular septal rupture, or failed transplant.

Most likely, only men and larger women would be eligible to receive the 2-pound device.

In Abiomed's 14-patient study, patients were an average 6 feet tall and weighed 170–180 pounds, Dr. Bram Zuckerman, director of FDA's Division of Cardiovascular Devices, said in a briefing with reporters.

The AbioCor is the result of almost 30 years of research and development, much of which was supported by the National Heart, Lung, and Blood Institute.

“The approval of the totally implanted artificial heart is a significant milestone as there are few options for heart failure patients with the most severe form of the disease and who are in critical need,” the NHLBI's director, Dr. Elizabeth G. Nabel, said in a statement.

The implanted system consists of an artificial heart, a battery, and two controllers that receive information via radio waves from an external controller and power source. Patients can be away from a power source for up to 1 hour—an important quality-of-life consideration that influenced the FDA's approval decision, Dr. Zuckerman said.

In Abiomed's original study—in 14 patients from 2001 to 2004—6 of the 12 patients who survived surgery were ambulatory and 4 made excursions outside of the hospital. One patient was discharged to home. The mean life span on AbioCor was 5 months, but the range was 53–512 days.

“Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is, in the view of many patients and family members, a significant improvement in quality of life,” Dr. Zuckerman said.

The FDA approval comes despite a 7–6 vote against approval by an FDA advisory panel in June 2005. The committee had concerns about clotting and stroke risk.

After the first five patients were implanted and died, Abiomed conducted autopsies that led the company to slightly redesign the AbioCor, which was accepted by the FDA, said company chairman and CEO Michael R. Minogue in an interview. Anticoagulation continued to be a challenge in the next nine patients, however.

The company has learned that only patients who can tolerate anticoagulation therapy should receive the AbioCor, Mr. Minogue said. In a planned postapproval study, which will enroll all patients implanted with the device, the company will determine how to best manage patients and whether it can appropriately train surgeons at new clinical sites.

The first implants will occur at Jewish Hospital in Louisville, Ky., where Dr. Laman Gray, director of the division of thoracic and cardiovascular surgery at the University of Louisville, and Dr. Rob Dowling, director of the heart transplant and cardiac assist devices program at Jewish Hospital, have implanted 7 of the original 14 devices since 2001.

Both Johns Hopkins Hospital, in Baltimore, and the Robert Wood Johnson University Hospital, in New Brunswick, N.J., also have entered into letters of intent to implant the AbioCor. Mr. Minogue said he expects training at these facilities to take at least 8–10 months.

The company aims to bring 5–10 centers on line. The AbioCor 2 is currently in development. It will be 30% smaller, have a different pump system, and will last up to 5 years, Mr. Minogue said.

In a sweeping, 1,000-page proposal, the Centers for Medicare and Medicaid Services is seeking to change how it pays for procedures performed in outpatient departments and at ambulatory surgery centers. Two goals are to rein in rising outpatient expenses and to level the payment differential between ASCs and outpatient departments.

In a statement, CMS Administrator Mark McClellan said that it was time to look more closely at outpatient payments: “Doing nothing is not sustainable from the standpoint of Medicare costs and beneficiary premiums, and we want public input on the best approaches to promoting high-quality, affordable care.”

With 12% growth in 2006 and projected growth of 10% for 2007, outpatient costs are putting a squeeze on beneficiaries, who must make 25% copayments, Dr. McClellan said during a press briefing sponsored by the agency.

CMS is proposing that hospitals receive an average 3% increase in outpatient payments if they submit quality data on the inpatient side. Hospitals would be required to report on patient satisfaction to receive the full inpatient and outpatient update. They would also report risk-adjusted outcome measures, including 30-day mortality for acute myocardial infarction, heart failure, and pneumonia, and three measures from the Surgical Care Improvement Project. The agency said it anticipates asking for outpatient quality data as outpatient-specific measures are developed.

Hospitals that do not submit quality data will be penalized. Instead of the full outpatient rate, they'll receive the outpatient update minus 2%. Overall, outpatient spending—which covers general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children's hospitals, and cancer hospitals—will hit $32.5 billion in 2007 under the proposed rule.

The agency is also proposing to increase from three to five the number of payment levels for visits to an outpatient clinic or emergency department. The maximum payment for clinic visits would be $133, up from $92, and emergency department visits would rise from $244 in 2006 to $345 in 2007. CMS also would create a new set of Healthcare Common Procedure Coding System (HCPCS) codes for visits to dedicated emergency departments (DEDs) subject to the Emergency Medical Treatment and Labor Act. The new codes would help CMS determine the relative cost of services provided at DEDs compared with emergent care furnished at a 24-hour-a-day, 7-day-a-week facility.

Most individual outpatient procedures will receive a small increase in reimbursement, but some are also slated for a reduction. Insertion, replacement, or repair of an implantable cardioverter defibrillator lead would be covered at $22,800 in 2007, up from $22,300 in 2006, and insertion or replacement of a pacemaker pulse generator would be paid at $16,400, up from $10,000, according to Washington Analysis, LLC, which follows Medicare developments for Wall Street.

Drug infusion devices would receive relatively large increases of 23%–56% but neurostimulator implantation would decrease from $11,600 in 2006 to $10,800, according to the report by Washington Analysis.

The rule would also change how hospitals are paid for drug infusions. Currently, hospitals are paid the same for each type of infusion, whether it takes an hour or several hours. Under the new rule, hospitals would be paid for the initial hour plus additional fees for more hours. They also would receive a larger payment for complex drug administration.

On the ASC side, the goal “is to help our beneficiaries get the outpatient care they need in the most appropriate setting, by eliminating payment differences that inappropriately favor one outpatient setting over another and that may add to Medicare costs,” Dr. McClellan, who has since resigned his position, said.

In 2007, CMS is proposing to cap the amount paid to ASCs at no more than the reimbursement for outpatient departments, to produce at least $150 million in savings. The agency also proposed to add 14 more procedures to the list of what it will cover at ASCs in 2007—including wound repair, percutaneous vertebroplasty, repair of venous blockage, ligation of hemorrhoids, and percutaneous transcatheter stent placement—and another 763 procedures in 2008. Any procedure that is considered safe and does not require an overnight stay would be considered eligible for Medicare reimbursement in 2008.

ASCs said they had no objection to bringing payments in line with those received by outpatient departments. But the industry was upset over CMS's proposal for a 2-year phase-in of a new payment system, beginning in 2008. By 2009, ASCs would be reimbursed at 62% of the outpatient rate. The industry—which includes about 4,500 centers—had been hoping to receive 75% of the outpatient rate.

“The proposed payment rate will result in Medicare beneficiaries and the Medicare program paying more for outpatient surgery because patients' only choice for many surgical procedures will be the more costly hospital setting,” said Kathy Bryant, president of the Federation of Ambulatory Surgery Centers, in a statement. The proposed rate will discourage many ASCs from offering certain procedures, said Ms. Bryant.

In a statement, the American Association of Ambulatory Surgery Centers called on members to submit comments to CMS objecting to the new proposal and to do the same with their congressional representatives.

CMS is receiving comments on the outpatient and ASC-payment proposal until Oct. 10. A final rule will be published later in the fall, the agency said.

In a sweeping, 1,000-page proposal, the Centers for Medicare and Medicaid Services is seeking to change how it pays for procedures performed in outpatient departments and at ambulatory surgery centers. Two goals are to rein in rising outpatient expenses and to level the payment differential between ASCs and outpatient departments.

In a statement, CMS Administrator Mark McClellan said that it was time to look more closely at outpatient payments: “Doing nothing is not sustainable from the standpoint of Medicare costs and beneficiary premiums, and we want public input on the best approaches to promoting high-quality, affordable care.”

With 12% growth in 2006 and projected growth of 10% for 2007, outpatient costs are putting a squeeze on beneficiaries, who must make 25% copayments, Dr. McClellan said during a press briefing sponsored by the agency.

CMS is proposing that hospitals receive an average 3% increase in outpatient payments if they submit quality data on the inpatient side. Hospitals would be required to report on patient satisfaction to receive the full inpatient and outpatient update. They would also report risk-adjusted outcome measures, including 30-day mortality for acute myocardial infarction, heart failure, and pneumonia, and three measures from the Surgical Care Improvement Project. The agency said it anticipates asking for outpatient quality data as outpatient-specific measures are developed.

Hospitals that do not submit quality data will be penalized. Instead of the full outpatient rate, they'll receive the outpatient update minus 2%. Overall, outpatient spending—which covers general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children's hospitals, and cancer hospitals—will hit $32.5 billion in 2007 under the proposed rule.

The agency is also proposing to increase from three to five the number of payment levels for visits to an outpatient clinic or emergency department. The maximum payment for clinic visits would be $133, up from $92, and emergency department visits would rise from $244 in 2006 to $345 in 2007. CMS also would create a new set of Healthcare Common Procedure Coding System (HCPCS) codes for visits to dedicated emergency departments (DEDs) subject to the Emergency Medical Treatment and Labor Act. The new codes would help CMS determine the relative cost of services provided at DEDs compared with emergent care furnished at a 24-hour-a-day, 7-day-a-week facility.

Most individual outpatient procedures will receive a small increase in reimbursement, but some are also slated for a reduction. Insertion, replacement, or repair of an implantable cardioverter defibrillator lead would be covered at $22,800 in 2007, up from $22,300 in 2006, and insertion or replacement of a pacemaker pulse generator would be paid at $16,400, up from $10,000, according to Washington Analysis, LLC, which follows Medicare developments for Wall Street.

Drug infusion devices would receive relatively large increases of 23%–56% but neurostimulator implantation would decrease from $11,600 in 2006 to $10,800, according to the report by Washington Analysis.

The rule would also change how hospitals are paid for drug infusions. Currently, hospitals are paid the same for each type of infusion, whether it takes an hour or several hours. Under the new rule, hospitals would be paid for the initial hour plus additional fees for more hours. They also would receive a larger payment for complex drug administration.

On the ASC side, the goal “is to help our beneficiaries get the outpatient care they need in the most appropriate setting, by eliminating payment differences that inappropriately favor one outpatient setting over another and that may add to Medicare costs,” Dr. McClellan, who has since resigned his position, said.

In 2007, CMS is proposing to cap the amount paid to ASCs at no more than the reimbursement for outpatient departments, to produce at least $150 million in savings. The agency also proposed to add 14 more procedures to the list of what it will cover at ASCs in 2007—including wound repair, percutaneous vertebroplasty, repair of venous blockage, ligation of hemorrhoids, and percutaneous transcatheter stent placement—and another 763 procedures in 2008. Any procedure that is considered safe and does not require an overnight stay would be considered eligible for Medicare reimbursement in 2008.

ASCs said they had no objection to bringing payments in line with those received by outpatient departments. But the industry was upset over CMS's proposal for a 2-year phase-in of a new payment system, beginning in 2008. By 2009, ASCs would be reimbursed at 62% of the outpatient rate. The industry—which includes about 4,500 centers—had been hoping to receive 75% of the outpatient rate.

“The proposed payment rate will result in Medicare beneficiaries and the Medicare program paying more for outpatient surgery because patients' only choice for many surgical procedures will be the more costly hospital setting,” said Kathy Bryant, president of the Federation of Ambulatory Surgery Centers, in a statement. The proposed rate will discourage many ASCs from offering certain procedures, said Ms. Bryant.

In a statement, the American Association of Ambulatory Surgery Centers called on members to submit comments to CMS objecting to the new proposal and to do the same with their congressional representatives.

CMS is receiving comments on the outpatient and ASC-payment proposal until Oct. 10. A final rule will be published later in the fall, the agency said.

In a sweeping, 1,000-page proposal, the Centers for Medicare and Medicaid Services is seeking to change how it pays for procedures performed in outpatient departments and at ambulatory surgery centers. Two goals are to rein in rising outpatient expenses and to level the payment differential between ASCs and outpatient departments.

In a statement, CMS Administrator Mark McClellan said that it was time to look more closely at outpatient payments: “Doing nothing is not sustainable from the standpoint of Medicare costs and beneficiary premiums, and we want public input on the best approaches to promoting high-quality, affordable care.”

With 12% growth in 2006 and projected growth of 10% for 2007, outpatient costs are putting a squeeze on beneficiaries, who must make 25% copayments, Dr. McClellan said during a press briefing sponsored by the agency.

CMS is proposing that hospitals receive an average 3% increase in outpatient payments if they submit quality data on the inpatient side. Hospitals would be required to report on patient satisfaction to receive the full inpatient and outpatient update. They would also report risk-adjusted outcome measures, including 30-day mortality for acute myocardial infarction, heart failure, and pneumonia, and three measures from the Surgical Care Improvement Project. The agency said it anticipates asking for outpatient quality data as outpatient-specific measures are developed.

Hospitals that do not submit quality data will be penalized. Instead of the full outpatient rate, they'll receive the outpatient update minus 2%. Overall, outpatient spending—which covers general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children's hospitals, and cancer hospitals—will hit $32.5 billion in 2007 under the proposed rule.

The agency is also proposing to increase from three to five the number of payment levels for visits to an outpatient clinic or emergency department. The maximum payment for clinic visits would be $133, up from $92, and emergency department visits would rise from $244 in 2006 to $345 in 2007. CMS also would create a new set of Healthcare Common Procedure Coding System (HCPCS) codes for visits to dedicated emergency departments (DEDs) subject to the Emergency Medical Treatment and Labor Act. The new codes would help CMS determine the relative cost of services provided at DEDs compared with emergent care furnished at a 24-hour-a-day, 7-day-a-week facility.

Most individual outpatient procedures will receive a small increase in reimbursement, but some are also slated for a reduction. Insertion, replacement, or repair of an implantable cardioverter defibrillator lead would be covered at $22,800 in 2007, up from $22,300 in 2006, and insertion or replacement of a pacemaker pulse generator would be paid at $16,400, up from $10,000, according to Washington Analysis, LLC, which follows Medicare developments for Wall Street.

Drug infusion devices would receive relatively large increases of 23%–56% but neurostimulator implantation would decrease from $11,600 in 2006 to $10,800, according to the report by Washington Analysis.

The rule would also change how hospitals are paid for drug infusions. Currently, hospitals are paid the same for each type of infusion, whether it takes an hour or several hours. Under the new rule, hospitals would be paid for the initial hour plus additional fees for more hours. They also would receive a larger payment for complex drug administration.

On the ASC side, the goal “is to help our beneficiaries get the outpatient care they need in the most appropriate setting, by eliminating payment differences that inappropriately favor one outpatient setting over another and that may add to Medicare costs,” Dr. McClellan, who has since resigned his position, said.

In 2007, CMS is proposing to cap the amount paid to ASCs at no more than the reimbursement for outpatient departments, to produce at least $150 million in savings. The agency also proposed to add 14 more procedures to the list of what it will cover at ASCs in 2007—including wound repair, percutaneous vertebroplasty, repair of venous blockage, ligation of hemorrhoids, and percutaneous transcatheter stent placement—and another 763 procedures in 2008. Any procedure that is considered safe and does not require an overnight stay would be considered eligible for Medicare reimbursement in 2008.

ASCs said they had no objection to bringing payments in line with those received by outpatient departments. But the industry was upset over CMS's proposal for a 2-year phase-in of a new payment system, beginning in 2008. By 2009, ASCs would be reimbursed at 62% of the outpatient rate. The industry—which includes about 4,500 centers—had been hoping to receive 75% of the outpatient rate.

“The proposed payment rate will result in Medicare beneficiaries and the Medicare program paying more for outpatient surgery because patients' only choice for many surgical procedures will be the more costly hospital setting,” said Kathy Bryant, president of the Federation of Ambulatory Surgery Centers, in a statement. The proposed rate will discourage many ASCs from offering certain procedures, said Ms. Bryant.

In a statement, the American Association of Ambulatory Surgery Centers called on members to submit comments to CMS objecting to the new proposal and to do the same with their congressional representatives.

CMS is receiving comments on the outpatient and ASC-payment proposal until Oct. 10. A final rule will be published later in the fall, the agency said.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports.

It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.,” he said.

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon, inasmuch as it took 3 years to pull them together.

“So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints,” he said.

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, who served as cochair of the guideline writing committee.

“The result was substantial differences among guidelines,” he added.

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction due to a prior MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, Dr. Myerburg said.

And cultural, financial and societal considerations may impact how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world, Dr. Myerburg said.

The guidelines' executive summary is published in the societies' journals and online at the ACC, AHA, and ESC Web sites.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports.

It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.,” he said.

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon, inasmuch as it took 3 years to pull them together.

“So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints,” he said.

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, who served as cochair of the guideline writing committee.

“The result was substantial differences among guidelines,” he added.

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction due to a prior MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, Dr. Myerburg said.

And cultural, financial and societal considerations may impact how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world, Dr. Myerburg said.

The guidelines' executive summary is published in the societies' journals and online at the ACC, AHA, and ESC Web sites.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports.

It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.,” he said.

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon, inasmuch as it took 3 years to pull them together.

“So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints,” he said.

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, who served as cochair of the guideline writing committee.

“The result was substantial differences among guidelines,” he added.

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction due to a prior MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, Dr. Myerburg said.

And cultural, financial and societal considerations may impact how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world, Dr. Myerburg said.

The guidelines' executive summary is published in the societies' journals and online at the ACC, AHA, and ESC Web sites.

AAD: iPledge Not Working

The vast majority of dermatologists are dissatisfied with the iPledge program governing prescription isotretinoin, according to a survey by the American Academy of Dermatology. Ninety percent of the 400 dermatologists who participated in the August telephone poll reported having difficulties with iPledge. The two biggest problems: getting help from the call center and difficulty with scheduling appointments because of the 30-day waiting period. Dermatologists also cited technical trouble with the online program and difficulties registering patients. Eighty-one percent said their patients had trouble with the program, most commonly a disruption in care because the patients didn't pick up the prescription within 7 days of the office visit. Covance, the company administering the program, said in a statement that since March, call wait times have declined to less than 3 minutes. Call volume is down, too—from 126,000 in March to 45,300 in August. Overall, 185,000 patients, 26,000 physicians, and 51,000 pharmacies have registered, according to Covance.

Parents Can Influence Sun Safety

Researchers at Pennsylvania State University have determined that children have better sun safety habits when "the quality of the parent-child relationship is high, the child exhibits high levels of compliance, and there are low levels of negative communication in the home." If the parent is warm, trusting, and a good listener, the child is more likely to listen to parents about skin cancer risks, said the authors, whose study appeared in the August Archives of Dermatology. In the study, parents of 340 children aged 9–12 were given a handbook on sun safety at the start of summer and then were given interventions for their children. A control group of parents of 129 children the same age was given handbooks but no suggested interventions. Each parent was offered $40 and each child $45. July assessments found that children in the intervention group had significantly fewer and less severe sunburns, engaged in less frequent intentional sunbathing, had more positive attitudes about sunscreen, and showed less positive attitudes about tanning.

Wound Healing Grants From NIH

The National Institute of Health's National Institute of General Medical Sciences is offering $13 million over the next 4 years to establish four centers that will develop wound therapies. According to the NIGMS, the goal is to bring together microbiologists, engineers, cell biologists, dermatologists, and other physicians. The centers and their lead principal investigators include Andrew Baird, Ph.D., at the La Jolla Institute for Molecular Medicine; Luisa DiPietro, Ph.D., at the University of Illinois at Chicago; Dr. Gregg Semenza at Johns Hopkins University, Baltimore; and Philip Stewart, Ph.D., at Montana State University, Bozeman.

U.S. Cancer Deaths Decrease

The rate of new cancers was stable from 1992 to 2003, but deaths from malignancies continued to decline, according to the "Annual Report to the Nation on the Status of Cancer" in the Oct. 15 issue of Cancer, published online in September. The cancer incidence for men was stable from 1995 to 2003, but incidence for women increased from 1979 to 2003. Death rates decreased for 11 of the 15 most common cancers for men and for 10 of the 15 most common cancers for women. Incidence rates for breast cancer stabilized from 2001 to 2003, but it's not clear if that is a true trend, according to the report. Women saw a decrease in new cancers of the colon, uterus, ovaries, stomach, and cervix and an increase in non-Hodgkin's lymphoma, melanoma, leukemia, and lung, bladder, and kidney cancers. Men saw a decrease in colon, stomach, oral, and lung cancers but an increase in prostate, liver, kidney, and esophageal cancers, and in leukemia and myeloma. The report also has a special section on the U.S. Hispanic population.

NDC Directory Incomplete, Says IG

The Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely due to drug companies' failure to submit required data, according to a report from the Health and Human Services Department's Office of Inspector General. The NDC Directory is supposed to be a current compendium of marketed drug products. As of February 2005, there were 123,856 products with unique codes in the directory, but 9,000 drug products were missing, said the IG. For 16% of missing listings, the drug maker had not submitted required FDA forms, but in some cases, the agency had not appropriately processed the forms. Some 5,100 products were pending and 34,000 were listed that were no longer marketed, because the companies had failed to provide needed information. In August, the FDA proposed a rule to require drug makers to submit data electronically.

AAD: iPledge Not Working

The vast majority of dermatologists are dissatisfied with the iPledge program governing prescription isotretinoin, according to a survey by the American Academy of Dermatology. Ninety percent of the 400 dermatologists who participated in the August telephone poll reported having difficulties with iPledge. The two biggest problems: getting help from the call center and difficulty with scheduling appointments because of the 30-day waiting period. Dermatologists also cited technical trouble with the online program and difficulties registering patients. Eighty-one percent said their patients had trouble with the program, most commonly a disruption in care because the patients didn't pick up the prescription within 7 days of the office visit. Covance, the company administering the program, said in a statement that since March, call wait times have declined to less than 3 minutes. Call volume is down, too—from 126,000 in March to 45,300 in August. Overall, 185,000 patients, 26,000 physicians, and 51,000 pharmacies have registered, according to Covance.

Parents Can Influence Sun Safety

Researchers at Pennsylvania State University have determined that children have better sun safety habits when "the quality of the parent-child relationship is high, the child exhibits high levels of compliance, and there are low levels of negative communication in the home." If the parent is warm, trusting, and a good listener, the child is more likely to listen to parents about skin cancer risks, said the authors, whose study appeared in the August Archives of Dermatology. In the study, parents of 340 children aged 9–12 were given a handbook on sun safety at the start of summer and then were given interventions for their children. A control group of parents of 129 children the same age was given handbooks but no suggested interventions. Each parent was offered $40 and each child $45. July assessments found that children in the intervention group had significantly fewer and less severe sunburns, engaged in less frequent intentional sunbathing, had more positive attitudes about sunscreen, and showed less positive attitudes about tanning.

Wound Healing Grants From NIH

The National Institute of Health's National Institute of General Medical Sciences is offering $13 million over the next 4 years to establish four centers that will develop wound therapies. According to the NIGMS, the goal is to bring together microbiologists, engineers, cell biologists, dermatologists, and other physicians. The centers and their lead principal investigators include Andrew Baird, Ph.D., at the La Jolla Institute for Molecular Medicine; Luisa DiPietro, Ph.D., at the University of Illinois at Chicago; Dr. Gregg Semenza at Johns Hopkins University, Baltimore; and Philip Stewart, Ph.D., at Montana State University, Bozeman.

U.S. Cancer Deaths Decrease

The rate of new cancers was stable from 1992 to 2003, but deaths from malignancies continued to decline, according to the "Annual Report to the Nation on the Status of Cancer" in the Oct. 15 issue of Cancer, published online in September. The cancer incidence for men was stable from 1995 to 2003, but incidence for women increased from 1979 to 2003. Death rates decreased for 11 of the 15 most common cancers for men and for 10 of the 15 most common cancers for women. Incidence rates for breast cancer stabilized from 2001 to 2003, but it's not clear if that is a true trend, according to the report. Women saw a decrease in new cancers of the colon, uterus, ovaries, stomach, and cervix and an increase in non-Hodgkin's lymphoma, melanoma, leukemia, and lung, bladder, and kidney cancers. Men saw a decrease in colon, stomach, oral, and lung cancers but an increase in prostate, liver, kidney, and esophageal cancers, and in leukemia and myeloma. The report also has a special section on the U.S. Hispanic population.

NDC Directory Incomplete, Says IG

The Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely due to drug companies' failure to submit required data, according to a report from the Health and Human Services Department's Office of Inspector General. The NDC Directory is supposed to be a current compendium of marketed drug products. As of February 2005, there were 123,856 products with unique codes in the directory, but 9,000 drug products were missing, said the IG. For 16% of missing listings, the drug maker had not submitted required FDA forms, but in some cases, the agency had not appropriately processed the forms. Some 5,100 products were pending and 34,000 were listed that were no longer marketed, because the companies had failed to provide needed information. In August, the FDA proposed a rule to require drug makers to submit data electronically.

AAD: iPledge Not Working

The vast majority of dermatologists are dissatisfied with the iPledge program governing prescription isotretinoin, according to a survey by the American Academy of Dermatology. Ninety percent of the 400 dermatologists who participated in the August telephone poll reported having difficulties with iPledge. The two biggest problems: getting help from the call center and difficulty with scheduling appointments because of the 30-day waiting period. Dermatologists also cited technical trouble with the online program and difficulties registering patients. Eighty-one percent said their patients had trouble with the program, most commonly a disruption in care because the patients didn't pick up the prescription within 7 days of the office visit. Covance, the company administering the program, said in a statement that since March, call wait times have declined to less than 3 minutes. Call volume is down, too—from 126,000 in March to 45,300 in August. Overall, 185,000 patients, 26,000 physicians, and 51,000 pharmacies have registered, according to Covance.

Parents Can Influence Sun Safety

Researchers at Pennsylvania State University have determined that children have better sun safety habits when "the quality of the parent-child relationship is high, the child exhibits high levels of compliance, and there are low levels of negative communication in the home." If the parent is warm, trusting, and a good listener, the child is more likely to listen to parents about skin cancer risks, said the authors, whose study appeared in the August Archives of Dermatology. In the study, parents of 340 children aged 9–12 were given a handbook on sun safety at the start of summer and then were given interventions for their children. A control group of parents of 129 children the same age was given handbooks but no suggested interventions. Each parent was offered $40 and each child $45. July assessments found that children in the intervention group had significantly fewer and less severe sunburns, engaged in less frequent intentional sunbathing, had more positive attitudes about sunscreen, and showed less positive attitudes about tanning.

Wound Healing Grants From NIH

The National Institute of Health's National Institute of General Medical Sciences is offering $13 million over the next 4 years to establish four centers that will develop wound therapies. According to the NIGMS, the goal is to bring together microbiologists, engineers, cell biologists, dermatologists, and other physicians. The centers and their lead principal investigators include Andrew Baird, Ph.D., at the La Jolla Institute for Molecular Medicine; Luisa DiPietro, Ph.D., at the University of Illinois at Chicago; Dr. Gregg Semenza at Johns Hopkins University, Baltimore; and Philip Stewart, Ph.D., at Montana State University, Bozeman.

U.S. Cancer Deaths Decrease

The rate of new cancers was stable from 1992 to 2003, but deaths from malignancies continued to decline, according to the "Annual Report to the Nation on the Status of Cancer" in the Oct. 15 issue of Cancer, published online in September. The cancer incidence for men was stable from 1995 to 2003, but incidence for women increased from 1979 to 2003. Death rates decreased for 11 of the 15 most common cancers for men and for 10 of the 15 most common cancers for women. Incidence rates for breast cancer stabilized from 2001 to 2003, but it's not clear if that is a true trend, according to the report. Women saw a decrease in new cancers of the colon, uterus, ovaries, stomach, and cervix and an increase in non-Hodgkin's lymphoma, melanoma, leukemia, and lung, bladder, and kidney cancers. Men saw a decrease in colon, stomach, oral, and lung cancers but an increase in prostate, liver, kidney, and esophageal cancers, and in leukemia and myeloma. The report also has a special section on the U.S. Hispanic population.

NDC Directory Incomplete, Says IG

The Food and Drug Administration's National Drug Code Directory is incomplete and inaccurate, largely due to drug companies' failure to submit required data, according to a report from the Health and Human Services Department's Office of Inspector General. The NDC Directory is supposed to be a current compendium of marketed drug products. As of February 2005, there were 123,856 products with unique codes in the directory, but 9,000 drug products were missing, said the IG. For 16% of missing listings, the drug maker had not submitted required FDA forms, but in some cases, the agency had not appropriately processed the forms. Some 5,100 products were pending and 34,000 were listed that were no longer marketed, because the companies had failed to provide needed information. In August, the FDA proposed a rule to require drug makers to submit data electronically.