Mary Ellen Schneider

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

Brian Gladnick, and colleagues from the Hospital for Special Surgery in New York, conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years; 9 had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures.

“FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The FDA has been following the issue since 2008, when case reports showed that atypical subtrochanteric femur fractures were occurring in osteoporotic women using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate manufacturers about this potential safety issue. The agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist and professor of medicine at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force. Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, she said.

And indeed, a study published a week after the FDA's statement suggested that the risk of subtrochanteric femur fractures is not significantly increased in women taking bisphosphonates, even among those treated for up to 10 years.

That study included a review of 283 hip or femur fractures in 14,195 women with 51,287 patient-years of follow-up and showed that only 12 subtrochanteric or diaphyseal femur fractures occurred in 10 women, for a rate of 2.3 per 10,000 patient years, Dennis M. Black, Ph.D., of the University of California at San Francisco and his colleagues wrote.

The analysis included data from the phase III Fracture Intervention Trial (FIT), the FIT Long-Term Extension (FLEX) trial, and the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT); the relative hazard ratios for subtrochanteric and diaphyseal femur fractures were 1.03 for alendronate vs. placebo in the FIT trial, 1.50 for zoledronic acid vs. placebo in the HORIZON-PFT trial, and 1.33 for continued alendronate use vs. placebo in the FLEX trial (N. Engl. J. Med. 2010 March 24[doi10.1056/NEJMoa1001086

Dr. Shane noted in an interview that “[i]t may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

The Hospital for Special Surgery study was supported by a grant from the National Institutes of Health. The Columbia researchers received no compensation for their study. Dr. Shane receives research support from Eli Lilly, Merck, and Novartis. The three-study analysis was supported by Merck and Novartis. The investigators reported financial relationships with Merck and Novartis.

“We don't yet know who is vulnerable” to rare instances of atypical femur fracture, Dr. Elizabeth Shane said.

Source Courtesy Columbia University Medical Center

A typical osteoporotic fracture (left) is contrasted with an atypical subtrochanteric fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Smoke Signals May Be False Alarm

It's against the law to shout “fire” in a crowded theater (unless there really is a fire).

Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [

doi:10.1210/jc.2009-1947

Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors for the fractures.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

Brian Gladnick, and colleagues from the Hospital for Special Surgery in New York, conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years; 9 had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures.

“FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The FDA has been following the issue since 2008, when case reports showed that atypical subtrochanteric femur fractures were occurring in osteoporotic women using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate manufacturers about this potential safety issue. The agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist and professor of medicine at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force. Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, she said.

And indeed, a study published a week after the FDA's statement suggested that the risk of subtrochanteric femur fractures is not significantly increased in women taking bisphosphonates, even among those treated for up to 10 years.

That study included a review of 283 hip or femur fractures in 14,195 women with 51,287 patient-years of follow-up and showed that only 12 subtrochanteric or diaphyseal femur fractures occurred in 10 women, for a rate of 2.3 per 10,000 patient years, Dennis M. Black, Ph.D., of the University of California at San Francisco and his colleagues wrote.

The analysis included data from the phase III Fracture Intervention Trial (FIT), the FIT Long-Term Extension (FLEX) trial, and the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT); the relative hazard ratios for subtrochanteric and diaphyseal femur fractures were 1.03 for alendronate vs. placebo in the FIT trial, 1.50 for zoledronic acid vs. placebo in the HORIZON-PFT trial, and 1.33 for continued alendronate use vs. placebo in the FLEX trial (N. Engl. J. Med. 2010 March 24[doi10.1056/NEJMoa1001086

Dr. Shane noted in an interview that “[i]t may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

The Hospital for Special Surgery study was supported by a grant from the National Institutes of Health. The Columbia researchers received no compensation for their study. Dr. Shane receives research support from Eli Lilly, Merck, and Novartis. The three-study analysis was supported by Merck and Novartis. The investigators reported financial relationships with Merck and Novartis.

“We don't yet know who is vulnerable” to rare instances of atypical femur fracture, Dr. Elizabeth Shane said.

Source Courtesy Columbia University Medical Center

A typical osteoporotic fracture (left) is contrasted with an atypical subtrochanteric fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Smoke Signals May Be False Alarm

It's against the law to shout “fire” in a crowded theater (unless there really is a fire).

Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [

doi:10.1210/jc.2009-1947

Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors for the fractures.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

Brian Gladnick, and colleagues from the Hospital for Special Surgery in New York, conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years; 9 had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures.

“FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The FDA has been following the issue since 2008, when case reports showed that atypical subtrochanteric femur fractures were occurring in osteoporotic women using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate manufacturers about this potential safety issue. The agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist and professor of medicine at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force. Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, she said.

And indeed, a study published a week after the FDA's statement suggested that the risk of subtrochanteric femur fractures is not significantly increased in women taking bisphosphonates, even among those treated for up to 10 years.

That study included a review of 283 hip or femur fractures in 14,195 women with 51,287 patient-years of follow-up and showed that only 12 subtrochanteric or diaphyseal femur fractures occurred in 10 women, for a rate of 2.3 per 10,000 patient years, Dennis M. Black, Ph.D., of the University of California at San Francisco and his colleagues wrote.

The analysis included data from the phase III Fracture Intervention Trial (FIT), the FIT Long-Term Extension (FLEX) trial, and the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT); the relative hazard ratios for subtrochanteric and diaphyseal femur fractures were 1.03 for alendronate vs. placebo in the FIT trial, 1.50 for zoledronic acid vs. placebo in the HORIZON-PFT trial, and 1.33 for continued alendronate use vs. placebo in the FLEX trial (N. Engl. J. Med. 2010 March 24[doi10.1056/NEJMoa1001086

Dr. Shane noted in an interview that “[i]t may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

The Hospital for Special Surgery study was supported by a grant from the National Institutes of Health. The Columbia researchers received no compensation for their study. Dr. Shane receives research support from Eli Lilly, Merck, and Novartis. The three-study analysis was supported by Merck and Novartis. The investigators reported financial relationships with Merck and Novartis.

“We don't yet know who is vulnerable” to rare instances of atypical femur fracture, Dr. Elizabeth Shane said.

Source Courtesy Columbia University Medical Center

A typical osteoporotic fracture (left) is contrasted with an atypical subtrochanteric fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Smoke Signals May Be False Alarm

It's against the law to shout “fire” in a crowded theater (unless there really is a fire).

Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [

doi:10.1210/jc.2009-1947

Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors for the fractures.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

Kmart Offers Free Folic Acid

Kmart stores around the country are offering to fill folic acid prescriptions free through April. The move is part of partnership with the March of Dimes to educate women about healthy pregnancies. The offer is limited to the 0.4-mg, 0.8-mg, and 1-mg strengths.

Group Cites Maternal Care 'Crisis'

The human rights group Amnesty International has called on the United States to create an Office of Maternal Care to deal with troubling trends in maternal death in this country. In a report, “Deadly Delivery: The Maternal Health Care Crisis in the USA,” the group says that the high rate of cesarean sections across the United States and variable quality of care contribute to increased pregnancy complications. For example, the report says that although the use of compression stockings has reduced blood clots after cesarean sections in countries such as the United Kingdom, they aren't used consistently here. “Too many unnecessary C-sections are being performed; that is clear,” Rachel Ward, Amnesty International USA research and policy director, said in a statement. “And the government's failure to meet its own goals after 12 years suggests a new approach is necessary.” The Amnesty International report is available online at

www.amnestyusa.org/dignity/pdf/DeadlyDelivery.pdf

Bill Would Ban Future Gag Rule

Rep. Nita Lowey (D-N.Y.) and a small group of Democratic lawmakers are seeking to enact federal legislation that would prevent a future president from reinstating the Mexico City Policy, also known as the global gag rule. President Obama repealed the policy through executive order last year. Under the previous administration, the rule prevented federally funded, nongovernmental organizations operating outside the United States from providing abortions or abortion counseling—even if those activities were supported separately from the government grants. The new bill (H.R. 4879), introduced last month, says that no organization would be ineligible for U.S. funding simply because it used outside funding to provide certain health and counseling services. Similar legislation (S. 311) was introduced in the Senate last year but has not been passed.

Pro-Choice Groups Target Stupak

Rep. Bart Stupak (D-Mich.), who was much in the news for brokering a compromise that allowed him and some other antiabortion Democrats to support the health care reform bill, is now being targeted by some supporters of abortion rights. Pro-Choice America PAC and the Planned Parenthood Action Fund recently announced plans to mount a primary challenge against Rep. Stupak in this year's election. “The voters in Michigan's 1st District are looking for an alternative to Bart Stupak,” Nancy Keenan, president of NARAL Pro-Choice America, said in a statement. “For years, he has attacked women's freedom and privacy and, for the last several months, seized the national spotlight as he held health care reform hostage to his antichoice political views. The clock is ticking on Mr. Stupak's '15 minutes of fame.'” The groups have endorsed abortion-rights supporter Connie Saltonstall, a mediator who serves as board president of Hospice of Northwest Michigan. Michigan's primary election will be held Aug. 3.

Parents Don't Want to Talk About Sex

Even though parents realize it's important to talk to their children about sex, they just don't do it, according to a new study. The analysis of focus groups discussions among 131 parents of children ages 10-12 found that the parents typically perceived significant threats to their children from sex but hadn't spoken to their children on the topic. They also said that their children were regularly exposed to sexual content in the media, but many of the parents in the focus groups said they felt that their children were just too young have a talk with about intercourse. Some participants also said they didn't want to plant ideas in their children's heads if they weren't already thinking about sex. Other parents said they simply felt uncomfortable having the conversation with their children. The qualitative findings were published in the March issue of Perspectives on Sexual and Reproductive Health (Perspect. Sex. Reprod. Health 2010;42:56-63). The study was funded by the Office of Population Affairs in the Department of Health and Human Services.

Many Use Internet for Health Info

More than half (51%) of adults aged 18-64 years use the Internet to look up health information over the course of a year, but only a handful communicate with their providers by e-mail or another Internet route, according to a survey by the National Center for Health Statistics. About 3% of adults reported using online chat groups to learn about health topics. The survey showed women more likely than men to use the Internet to research health issues and to join chat groups. Almost 5% of adults said that they had communicated with a health provider online in the past year, while 6% requested a prescription refill online and 3% made an office appointment online. The analysis included data from 7,192 adults surveyed from January to June 2009.

Kmart Offers Free Folic Acid

Kmart stores around the country are offering to fill folic acid prescriptions free through April. The move is part of partnership with the March of Dimes to educate women about healthy pregnancies. The offer is limited to the 0.4-mg, 0.8-mg, and 1-mg strengths.

Group Cites Maternal Care 'Crisis'

The human rights group Amnesty International has called on the United States to create an Office of Maternal Care to deal with troubling trends in maternal death in this country. In a report, “Deadly Delivery: The Maternal Health Care Crisis in the USA,” the group says that the high rate of cesarean sections across the United States and variable quality of care contribute to increased pregnancy complications. For example, the report says that although the use of compression stockings has reduced blood clots after cesarean sections in countries such as the United Kingdom, they aren't used consistently here. “Too many unnecessary C-sections are being performed; that is clear,” Rachel Ward, Amnesty International USA research and policy director, said in a statement. “And the government's failure to meet its own goals after 12 years suggests a new approach is necessary.” The Amnesty International report is available online at

www.amnestyusa.org/dignity/pdf/DeadlyDelivery.pdf

Bill Would Ban Future Gag Rule

Rep. Nita Lowey (D-N.Y.) and a small group of Democratic lawmakers are seeking to enact federal legislation that would prevent a future president from reinstating the Mexico City Policy, also known as the global gag rule. President Obama repealed the policy through executive order last year. Under the previous administration, the rule prevented federally funded, nongovernmental organizations operating outside the United States from providing abortions or abortion counseling—even if those activities were supported separately from the government grants. The new bill (H.R. 4879), introduced last month, says that no organization would be ineligible for U.S. funding simply because it used outside funding to provide certain health and counseling services. Similar legislation (S. 311) was introduced in the Senate last year but has not been passed.

Pro-Choice Groups Target Stupak

Rep. Bart Stupak (D-Mich.), who was much in the news for brokering a compromise that allowed him and some other antiabortion Democrats to support the health care reform bill, is now being targeted by some supporters of abortion rights. Pro-Choice America PAC and the Planned Parenthood Action Fund recently announced plans to mount a primary challenge against Rep. Stupak in this year's election. “The voters in Michigan's 1st District are looking for an alternative to Bart Stupak,” Nancy Keenan, president of NARAL Pro-Choice America, said in a statement. “For years, he has attacked women's freedom and privacy and, for the last several months, seized the national spotlight as he held health care reform hostage to his antichoice political views. The clock is ticking on Mr. Stupak's '15 minutes of fame.'” The groups have endorsed abortion-rights supporter Connie Saltonstall, a mediator who serves as board president of Hospice of Northwest Michigan. Michigan's primary election will be held Aug. 3.

Parents Don't Want to Talk About Sex

Even though parents realize it's important to talk to their children about sex, they just don't do it, according to a new study. The analysis of focus groups discussions among 131 parents of children ages 10-12 found that the parents typically perceived significant threats to their children from sex but hadn't spoken to their children on the topic. They also said that their children were regularly exposed to sexual content in the media, but many of the parents in the focus groups said they felt that their children were just too young have a talk with about intercourse. Some participants also said they didn't want to plant ideas in their children's heads if they weren't already thinking about sex. Other parents said they simply felt uncomfortable having the conversation with their children. The qualitative findings were published in the March issue of Perspectives on Sexual and Reproductive Health (Perspect. Sex. Reprod. Health 2010;42:56-63). The study was funded by the Office of Population Affairs in the Department of Health and Human Services.

Many Use Internet for Health Info

More than half (51%) of adults aged 18-64 years use the Internet to look up health information over the course of a year, but only a handful communicate with their providers by e-mail or another Internet route, according to a survey by the National Center for Health Statistics. About 3% of adults reported using online chat groups to learn about health topics. The survey showed women more likely than men to use the Internet to research health issues and to join chat groups. Almost 5% of adults said that they had communicated with a health provider online in the past year, while 6% requested a prescription refill online and 3% made an office appointment online. The analysis included data from 7,192 adults surveyed from January to June 2009.

Kmart Offers Free Folic Acid

Kmart stores around the country are offering to fill folic acid prescriptions free through April. The move is part of partnership with the March of Dimes to educate women about healthy pregnancies. The offer is limited to the 0.4-mg, 0.8-mg, and 1-mg strengths.

Group Cites Maternal Care 'Crisis'

The human rights group Amnesty International has called on the United States to create an Office of Maternal Care to deal with troubling trends in maternal death in this country. In a report, “Deadly Delivery: The Maternal Health Care Crisis in the USA,” the group says that the high rate of cesarean sections across the United States and variable quality of care contribute to increased pregnancy complications. For example, the report says that although the use of compression stockings has reduced blood clots after cesarean sections in countries such as the United Kingdom, they aren't used consistently here. “Too many unnecessary C-sections are being performed; that is clear,” Rachel Ward, Amnesty International USA research and policy director, said in a statement. “And the government's failure to meet its own goals after 12 years suggests a new approach is necessary.” The Amnesty International report is available online at

www.amnestyusa.org/dignity/pdf/DeadlyDelivery.pdf

Bill Would Ban Future Gag Rule

Rep. Nita Lowey (D-N.Y.) and a small group of Democratic lawmakers are seeking to enact federal legislation that would prevent a future president from reinstating the Mexico City Policy, also known as the global gag rule. President Obama repealed the policy through executive order last year. Under the previous administration, the rule prevented federally funded, nongovernmental organizations operating outside the United States from providing abortions or abortion counseling—even if those activities were supported separately from the government grants. The new bill (H.R. 4879), introduced last month, says that no organization would be ineligible for U.S. funding simply because it used outside funding to provide certain health and counseling services. Similar legislation (S. 311) was introduced in the Senate last year but has not been passed.

Pro-Choice Groups Target Stupak

Rep. Bart Stupak (D-Mich.), who was much in the news for brokering a compromise that allowed him and some other antiabortion Democrats to support the health care reform bill, is now being targeted by some supporters of abortion rights. Pro-Choice America PAC and the Planned Parenthood Action Fund recently announced plans to mount a primary challenge against Rep. Stupak in this year's election. “The voters in Michigan's 1st District are looking for an alternative to Bart Stupak,” Nancy Keenan, president of NARAL Pro-Choice America, said in a statement. “For years, he has attacked women's freedom and privacy and, for the last several months, seized the national spotlight as he held health care reform hostage to his antichoice political views. The clock is ticking on Mr. Stupak's '15 minutes of fame.'” The groups have endorsed abortion-rights supporter Connie Saltonstall, a mediator who serves as board president of Hospice of Northwest Michigan. Michigan's primary election will be held Aug. 3.

Parents Don't Want to Talk About Sex

Even though parents realize it's important to talk to their children about sex, they just don't do it, according to a new study. The analysis of focus groups discussions among 131 parents of children ages 10-12 found that the parents typically perceived significant threats to their children from sex but hadn't spoken to their children on the topic. They also said that their children were regularly exposed to sexual content in the media, but many of the parents in the focus groups said they felt that their children were just too young have a talk with about intercourse. Some participants also said they didn't want to plant ideas in their children's heads if they weren't already thinking about sex. Other parents said they simply felt uncomfortable having the conversation with their children. The qualitative findings were published in the March issue of Perspectives on Sexual and Reproductive Health (Perspect. Sex. Reprod. Health 2010;42:56-63). The study was funded by the Office of Population Affairs in the Department of Health and Human Services.

Many Use Internet for Health Info

More than half (51%) of adults aged 18-64 years use the Internet to look up health information over the course of a year, but only a handful communicate with their providers by e-mail or another Internet route, according to a survey by the National Center for Health Statistics. About 3% of adults reported using online chat groups to learn about health topics. The survey showed women more likely than men to use the Internet to research health issues and to join chat groups. Almost 5% of adults said that they had communicated with a health provider online in the past year, while 6% requested a prescription refill online and 3% made an office appointment online. The analysis included data from 7,192 adults surveyed from January to June 2009.

The federal government has awarded $162 million in grants to states to aid in the secure exchange of health information across different proprietary systems.

The grants, which were announced on March 15, will go to 16 states and qualified state-designated entities. The money was set aside for states under the American Recovery and Reinvestment Act of 2009. This is the final round of grants, and follows the release of $385 million to 40 states and qualified state-designed entities in February.

“What these awards will do is strengthen our health care system and speed our economic recovery,” Kathleen Sebelius, Health and Human Services Secretary, said during a press conference to announce the grants. “They help to unleash the power of health information technology to cut costs, eliminate paperwork, and best of all help doctors deliver higher quality, coordinated care.”

Despite the benefits of adopting electronic health records (EHRs), only about 20% of physicians and 10% of hospitals have implemented even a basic EHR system, Ms. Sebelius said.

The goal in awarding these grants is that the states will be able to develop policies and frameworks based on nationally approved technical standards, which will allow physicians and hospitals to securely share information regardless of what type of EHR system they have implemented.

States will need to begin by bringing all the parties to the table—from physicians and hospitals to health insurers and lawyers, said Dr. David Blumenthal, the national coordinator for health information technology. These groups will need to agree on the strategic and operational plans for creating health-information exchange in each state, he said.

Health IT officials at the federal level will be working closely with the states on their plans for exchanging health data. But the states are in the best position to identify and credential physicians and hospitals that should be receiving and sending private and secure health information transmissions, Dr. Blumenthal said.

The states are currently at different points in their implementation timeline based on their past work on health information exchange, Dr. Blumenthal added. But he said he expects that many states will have the technology and governance structures in place by 2013 to allow physicians and hospitals to meet the information exchange requirements established under the federal incentive program for EHR implementation. That incentive program, created under the Recovery Act, calls for physicians and hospitals to demonstrate the ability to exchange information by 2011, but more robust exchange requirements do not phase in until 2013.

The federal government has awarded $162 million in grants to states to aid in the secure exchange of health information across different proprietary systems.

The grants, which were announced on March 15, will go to 16 states and qualified state-designated entities. The money was set aside for states under the American Recovery and Reinvestment Act of 2009. This is the final round of grants, and follows the release of $385 million to 40 states and qualified state-designed entities in February.

“What these awards will do is strengthen our health care system and speed our economic recovery,” Kathleen Sebelius, Health and Human Services Secretary, said during a press conference to announce the grants. “They help to unleash the power of health information technology to cut costs, eliminate paperwork, and best of all help doctors deliver higher quality, coordinated care.”

Despite the benefits of adopting electronic health records (EHRs), only about 20% of physicians and 10% of hospitals have implemented even a basic EHR system, Ms. Sebelius said.

The goal in awarding these grants is that the states will be able to develop policies and frameworks based on nationally approved technical standards, which will allow physicians and hospitals to securely share information regardless of what type of EHR system they have implemented.

States will need to begin by bringing all the parties to the table—from physicians and hospitals to health insurers and lawyers, said Dr. David Blumenthal, the national coordinator for health information technology. These groups will need to agree on the strategic and operational plans for creating health-information exchange in each state, he said.

Health IT officials at the federal level will be working closely with the states on their plans for exchanging health data. But the states are in the best position to identify and credential physicians and hospitals that should be receiving and sending private and secure health information transmissions, Dr. Blumenthal said.

The states are currently at different points in their implementation timeline based on their past work on health information exchange, Dr. Blumenthal added. But he said he expects that many states will have the technology and governance structures in place by 2013 to allow physicians and hospitals to meet the information exchange requirements established under the federal incentive program for EHR implementation. That incentive program, created under the Recovery Act, calls for physicians and hospitals to demonstrate the ability to exchange information by 2011, but more robust exchange requirements do not phase in until 2013.

The federal government has awarded $162 million in grants to states to aid in the secure exchange of health information across different proprietary systems.

The grants, which were announced on March 15, will go to 16 states and qualified state-designated entities. The money was set aside for states under the American Recovery and Reinvestment Act of 2009. This is the final round of grants, and follows the release of $385 million to 40 states and qualified state-designed entities in February.

“What these awards will do is strengthen our health care system and speed our economic recovery,” Kathleen Sebelius, Health and Human Services Secretary, said during a press conference to announce the grants. “They help to unleash the power of health information technology to cut costs, eliminate paperwork, and best of all help doctors deliver higher quality, coordinated care.”

Despite the benefits of adopting electronic health records (EHRs), only about 20% of physicians and 10% of hospitals have implemented even a basic EHR system, Ms. Sebelius said.

The goal in awarding these grants is that the states will be able to develop policies and frameworks based on nationally approved technical standards, which will allow physicians and hospitals to securely share information regardless of what type of EHR system they have implemented.

States will need to begin by bringing all the parties to the table—from physicians and hospitals to health insurers and lawyers, said Dr. David Blumenthal, the national coordinator for health information technology. These groups will need to agree on the strategic and operational plans for creating health-information exchange in each state, he said.

Health IT officials at the federal level will be working closely with the states on their plans for exchanging health data. But the states are in the best position to identify and credential physicians and hospitals that should be receiving and sending private and secure health information transmissions, Dr. Blumenthal said.

The states are currently at different points in their implementation timeline based on their past work on health information exchange, Dr. Blumenthal added. But he said he expects that many states will have the technology and governance structures in place by 2013 to allow physicians and hospitals to meet the information exchange requirements established under the federal incentive program for EHR implementation. That incentive program, created under the Recovery Act, calls for physicians and hospitals to demonstrate the ability to exchange information by 2011, but more robust exchange requirements do not phase in until 2013.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, which was released on March 2, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. The permanent program also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs, however, would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available where and when it is needed,” he said in a statement.

Earlier this year, the federal government issued a proposed rule outlining the criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for certification of products.

Two separate regulations finalizing the temporary and permanent certification programs are expected to be published by the fall.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, which was released on March 2, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. The permanent program also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs, however, would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available where and when it is needed,” he said in a statement.

Earlier this year, the federal government issued a proposed rule outlining the criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for certification of products.

Two separate regulations finalizing the temporary and permanent certification programs are expected to be published by the fall.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, which was released on March 2, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. The permanent program also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs, however, would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available where and when it is needed,” he said in a statement.

Earlier this year, the federal government issued a proposed rule outlining the criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for certification of products.

Two separate regulations finalizing the temporary and permanent certification programs are expected to be published by the fall.

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

“Although bisphosphonates have demonstrated an improvement in bone quantity, little if anything is known about the effects of these drugs on bone quality,” Brian Gladnick, one of the investigators from the Hospital for Special Surgery in New York, said in a statement.

Researchers at the Hospital for Special Surgery conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years. Nine of the women had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group. This study was supported by a grant from the National Institutes of Health.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity. The researchers received no compensation for this study.

Both groups of investigators called for more research to gauge the effectiveness of long-term clinical use of bisphosphonates for osteoporosis treatment. However, they did not expect the findings to affect clinical practice anytime soon.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

Further research could shed light on the best treatment approaches in women who have been taking bisphosphonates for more than 4 years. For example, it would be helpful for physicians to know the effects of a bisphosphonate drug holiday on bone quality, Dr. Rosenwasser said in an interview.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures. “FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The agency has been following the issue since 2008, when case reports were published showing that atypical subtrochanteric femur fractures were occurring in women with osteoporosis who were using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate drug manufacturers about this potential safety issue. However, the agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, said Dr. Shane, who receives research support from Eli Lilly, Merck, and Novartis.

“Every drug has side effects,” Dr. Shane said in an interview. “It may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

One of the goals of the task force convened by the American Society of Bone and Mineral Research will be to determine future research directions. The group, which began meeting last year, also is working to establish a case definition, review the literature, examine different imaging techniques, and consider the best management of patients with these fractures.

The task force expects to wrap up its work in the next few months, Dr. Shane said. Once completed, a report will be submitted to the Journal of Bone and Mineral Research and to the FDA. One action the task force is likely to recommend is the establishment of an international registry, allowing researchers to better study the rare fractures, she said.

To access the FDA statement, go to www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

A typical osteoporotic fracture (left) is contrasted with an atypical fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Don't Lose Sight of Benefits

It's against the law to shout “fire” in a crowded theater (unless there really is a fire). Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [doi:10.1210/jc.2009-1947]). Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

“Although bisphosphonates have demonstrated an improvement in bone quantity, little if anything is known about the effects of these drugs on bone quality,” Brian Gladnick, one of the investigators from the Hospital for Special Surgery in New York, said in a statement.

Researchers at the Hospital for Special Surgery conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years. Nine of the women had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group. This study was supported by a grant from the National Institutes of Health.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity. The researchers received no compensation for this study.

Both groups of investigators called for more research to gauge the effectiveness of long-term clinical use of bisphosphonates for osteoporosis treatment. However, they did not expect the findings to affect clinical practice anytime soon.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

Further research could shed light on the best treatment approaches in women who have been taking bisphosphonates for more than 4 years. For example, it would be helpful for physicians to know the effects of a bisphosphonate drug holiday on bone quality, Dr. Rosenwasser said in an interview.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures. “FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The agency has been following the issue since 2008, when case reports were published showing that atypical subtrochanteric femur fractures were occurring in women with osteoporosis who were using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate drug manufacturers about this potential safety issue. However, the agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, said Dr. Shane, who receives research support from Eli Lilly, Merck, and Novartis.

“Every drug has side effects,” Dr. Shane said in an interview. “It may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

One of the goals of the task force convened by the American Society of Bone and Mineral Research will be to determine future research directions. The group, which began meeting last year, also is working to establish a case definition, review the literature, examine different imaging techniques, and consider the best management of patients with these fractures.

The task force expects to wrap up its work in the next few months, Dr. Shane said. Once completed, a report will be submitted to the Journal of Bone and Mineral Research and to the FDA. One action the task force is likely to recommend is the establishment of an international registry, allowing researchers to better study the rare fractures, she said.

To access the FDA statement, go to www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

A typical osteoporotic fracture (left) is contrasted with an atypical fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Don't Lose Sight of Benefits

It's against the law to shout “fire” in a crowded theater (unless there really is a fire). Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [doi:10.1210/jc.2009-1947]). Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

Early results from two small studies show that the long-term use of oral bisphosphonates could harm bone quality and potentially lead to an increased risk for femur fractures, but the Food and Drug Administration is advising patients to stay on their medication unless advised by their physicians to stop.

The studies showed an association between the use of bisphosphonate treatments for 4 or more years and decreasing bone quality, possibly because the bisphosphonates altered the material properties of the bone. The two studies were presented at the annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans.

“Although bisphosphonates have demonstrated an improvement in bone quantity, little if anything is known about the effects of these drugs on bone quality,” Brian Gladnick, one of the investigators from the Hospital for Special Surgery in New York, said in a statement.

Researchers at the Hospital for Special Surgery conducted a prospective pilot study in which they evaluated the bone composition of 21 postmenopausal women who presented to the emergency department with proximal femoral fractures. Of the patients enrolled in the study, 12 had a history of bisphosphonate use for an average of 8.5 years. Nine of the women had never been treated with bisphosphonates.

The researchers performed bone core biopsies for each patient and analyzed both the micro-architecture and material properties of the bone. No difference in the bone micro-architecture was observed, but among the patients who had been treated with bisphosphonates, the investigators found reduced bone tissue heterogeneity. Specifically, those who had received bisphosphonates had reduced mineral content and crystal size, compared with the control group. This study was supported by a grant from the National Institutes of Health.

In a second study, researchers at Columbia University in New York evaluated the bone structure of 111 postmenopausal women with primary osteoporosis. Of that group, 61 had been taking bisphosphonates for at least 4 years. The other 50 women had been taking calcium and vitamin D supplements.

The researchers at Columbia saw improved structural integrity early in the bisphosphonate treatment. However, the trends began to reverse after 4 years of treatment. After that point, continued treatment was associated with decreased axial strength and structural integrity. The researchers received no compensation for this study.

Both groups of investigators called for more research to gauge the effectiveness of long-term clinical use of bisphosphonates for osteoporosis treatment. However, they did not expect the findings to affect clinical practice anytime soon.

“The message here is bisphosphonates are not bad drugs, but perhaps we need to know more about the long-term effects,” Dr. Melvin Rosenwasser, professor of orthopaedic surgery at Columbia University and one of the investigators on the Columbia study.

Further research could shed light on the best treatment approaches in women who have been taking bisphosphonates for more than 4 years. For example, it would be helpful for physicians to know the effects of a bisphosphonate drug holiday on bone quality, Dr. Rosenwasser said in an interview.

The FDA advised physicians to be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking bisphosphonates, but said that at this point they saw no “clear connection” between bisphosphonate use and the risk of these fractures. “FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the agency said in a statement.

The agency has been following the issue since 2008, when case reports were published showing that atypical subtrochanteric femur fractures were occurring in women with osteoporosis who were using bisphosphonates. In June 2008, the FDA requested information from all bisphosphonate drug manufacturers about this potential safety issue. However, the agency's review of the information did not show an increased risk for women using bisphosphonates.

Some of the manufacturers of bisphosphonate therapies (Fosamax, Actonel, Boniva, and Reclast) issued statements pledging to continue to monitor reports of atypical fractures, but stand by the benefits of the therapies.

The best information available to date indicates that atypical subtrochanteric fractures are rare, said Dr. Elizabeth Shane, an endocrinologist at Columbia University who also co-chairs the American Society for Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Preliminary estimates are that less than 1 in 10,000 patients taking bisphosphonates suffers from this type of fracture, she said. Contrast that with the fact that treating 1,000 women for 3 years with bisphosphonates can prevent 100 fractures, and the benefit of taking these drugs far outweighs the risks, said Dr. Shane, who receives research support from Eli Lilly, Merck, and Novartis.

“Every drug has side effects,” Dr. Shane said in an interview. “It may well be that this type of fracture is associated with bisphosphonates, but we don't yet know who is vulnerable and we need more information and more research in order to determine that.”

One of the goals of the task force convened by the American Society of Bone and Mineral Research will be to determine future research directions. The group, which began meeting last year, also is working to establish a case definition, review the literature, examine different imaging techniques, and consider the best management of patients with these fractures.

The task force expects to wrap up its work in the next few months, Dr. Shane said. Once completed, a report will be submitted to the Journal of Bone and Mineral Research and to the FDA. One action the task force is likely to recommend is the establishment of an international registry, allowing researchers to better study the rare fractures, she said.

To access the FDA statement, go to www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

A typical osteoporotic fracture (left) is contrasted with an atypical fracture in a patient after many years of bisphosphonate therapy.

Source Images courtesy Dr. Melvin Rosenwasser, Columbia University

My Take

Don't Lose Sight of Benefits

It's against the law to shout “fire” in a crowded theater (unless there really is a fire). Recent misleading reports in the lay press of cases of “atypical” femur fractures in patients taking Fosamax, and recent (non–peer reviewed) reports of orthopedic research suggesting a strong link between bisphosphonates and subtrochanteric femur fractures appear to be in that vein.

In a statement, the FDA said, “At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.” We have reviewed the data (J. Clin. Endocrinol. Metab. 2010 Feb. 19 [doi:10.1210/jc.2009-1947]). Because of the small number of cases reported, it is unlikely that a sufficiently large series of such fractures could be assembled to begin to tease out risk factors.

Lost in the “smoke” is the serious problem caused by osteoporosis, the deaths and disability associated with fractures and the benefits of alendronate and similar drugs in reducing the risk of fractures. Life is about balancing benefits with risks. For the vast majority of patients with osteoporosis, the benefits of alendronate and other approved treatments for osteoporosis far outweigh the risks.

NELSON B. WATTS, M.D., is an endocrinologist and director of the University of Cincinnati's bone health and osteoporosis center. He disclosed that he has relationships with several pharmaceutical companies, including Amgen Inc., Procter & Gamble, Sanofi-Aventis, and Novartis Pharmaceuticals Corp., which manufactures the bisphosphonate Reclast (zoledronic acid).

No H1N1 Vaccine–Syndrome Link

The pandemic influenza A(H1N1) vaccine does not appear to increase the risk of Guillain-Barr syndrome, according to the Centers for Disease Control and Prevention. The agency is basing its conclusion on surveillance in 10 states from Oct. 1, 2009 through Feb. 15, 2010. During that time, the CDC identified 166 confirmed or probable cases of Guillain-Barr syndrome. Of those, 13 were among patients who had been vaccinated against the H1N1 virus before their symptoms began. Although the current data don't suggest that there is an increased risk from the vaccine, the CDC emphasized the need for continued surveillance. Last fall, officials at the CDC called on neurologists to report any possible new cases of Guillain-Barr syndrome following H1N1 vaccination. In 1976, Guillain-Barr cases occurred in some of the people who received the swine flu vaccine at that time.

Gene-Test Registry Planned

With an eye toward understanding how genetics affects health, officials at the National Institutes of Health plan to establish by next year a single public registry for information on genetic tests. There are currently more than 1,600 genetics tests available but there is no single public way to search for information about their availability, validity, and usefulness, according to the NIH. “The need for this database reflects how far we have come in the last 10 years,” NIH director Dr. Francis S. Collins commented in a statement. “The registry will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible.” More information on the registry is available online at

www.ncbi.nlm.nih.gov/gtr/

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the “doughnut hole,” when they must pay 100% of prescription costs until the totals they and the plans pay reach $6,154, according to a report prepared by the Government Accountability Office. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole, or catastrophic threshold, beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, those used to treat cancer, and antiviral drugs. Medicare supplement-plan sponsors told the GAO that they had little leverage to negotiate price concessions for most of the specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years and states have cut a total of nearly $392 million in public health programs in the past year, according to a report from the Robert Wood Johnson Foundation and the Trust for America's Health. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person and considerably less than the $19.80 per person that states in the northeast received. Western states received $19.22 per person, whereas southern states got $19.75 per person.

Food Poisoning Cost Is Sickening

Each case of foodborne illness, such as from Escherichia coli and Campylobacter, costs an average of $1,850 in treatment and other health costs, totaling $152 billion for the nation annually, according to findings in a study by the Pew Charitable Trusts at Georgetown University in Washington. Cases related to tainted produce cost $39 billion in just medical costs per year. “Although this study only addresses the health-related costs of foodborne illness, the total cost of foodborne illness also includes costs to industry and government from outbreaks,” according to the report. Totals vary significantly among the states. The 10 states with the highest costs per case were Hawaii, Florida, Connecticut, Pennsylvania, South Carolina, the District of Columbia, Mississippi, New York, Massachusetts, and New Jersey. According to the Centers for Disease Control and Prevention, there are 76 million new cases of food-related illness that result in 5,000 deaths and 325,000 hospitalizations in the United States each year.

No H1N1 Vaccine–Syndrome Link

The pandemic influenza A(H1N1) vaccine does not appear to increase the risk of Guillain-Barr syndrome, according to the Centers for Disease Control and Prevention. The agency is basing its conclusion on surveillance in 10 states from Oct. 1, 2009 through Feb. 15, 2010. During that time, the CDC identified 166 confirmed or probable cases of Guillain-Barr syndrome. Of those, 13 were among patients who had been vaccinated against the H1N1 virus before their symptoms began. Although the current data don't suggest that there is an increased risk from the vaccine, the CDC emphasized the need for continued surveillance. Last fall, officials at the CDC called on neurologists to report any possible new cases of Guillain-Barr syndrome following H1N1 vaccination. In 1976, Guillain-Barr cases occurred in some of the people who received the swine flu vaccine at that time.

Gene-Test Registry Planned

With an eye toward understanding how genetics affects health, officials at the National Institutes of Health plan to establish by next year a single public registry for information on genetic tests. There are currently more than 1,600 genetics tests available but there is no single public way to search for information about their availability, validity, and usefulness, according to the NIH. “The need for this database reflects how far we have come in the last 10 years,” NIH director Dr. Francis S. Collins commented in a statement. “The registry will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible.” More information on the registry is available online at

www.ncbi.nlm.nih.gov/gtr/

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the “doughnut hole,” when they must pay 100% of prescription costs until the totals they and the plans pay reach $6,154, according to a report prepared by the Government Accountability Office. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole, or catastrophic threshold, beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, those used to treat cancer, and antiviral drugs. Medicare supplement-plan sponsors told the GAO that they had little leverage to negotiate price concessions for most of the specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years and states have cut a total of nearly $392 million in public health programs in the past year, according to a report from the Robert Wood Johnson Foundation and the Trust for America's Health. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person and considerably less than the $19.80 per person that states in the northeast received. Western states received $19.22 per person, whereas southern states got $19.75 per person.

Food Poisoning Cost Is Sickening

Each case of foodborne illness, such as from Escherichia coli and Campylobacter, costs an average of $1,850 in treatment and other health costs, totaling $152 billion for the nation annually, according to findings in a study by the Pew Charitable Trusts at Georgetown University in Washington. Cases related to tainted produce cost $39 billion in just medical costs per year. “Although this study only addresses the health-related costs of foodborne illness, the total cost of foodborne illness also includes costs to industry and government from outbreaks,” according to the report. Totals vary significantly among the states. The 10 states with the highest costs per case were Hawaii, Florida, Connecticut, Pennsylvania, South Carolina, the District of Columbia, Mississippi, New York, Massachusetts, and New Jersey. According to the Centers for Disease Control and Prevention, there are 76 million new cases of food-related illness that result in 5,000 deaths and 325,000 hospitalizations in the United States each year.

No H1N1 Vaccine–Syndrome Link

The pandemic influenza A(H1N1) vaccine does not appear to increase the risk of Guillain-Barr syndrome, according to the Centers for Disease Control and Prevention. The agency is basing its conclusion on surveillance in 10 states from Oct. 1, 2009 through Feb. 15, 2010. During that time, the CDC identified 166 confirmed or probable cases of Guillain-Barr syndrome. Of those, 13 were among patients who had been vaccinated against the H1N1 virus before their symptoms began. Although the current data don't suggest that there is an increased risk from the vaccine, the CDC emphasized the need for continued surveillance. Last fall, officials at the CDC called on neurologists to report any possible new cases of Guillain-Barr syndrome following H1N1 vaccination. In 1976, Guillain-Barr cases occurred in some of the people who received the swine flu vaccine at that time.

Gene-Test Registry Planned

With an eye toward understanding how genetics affects health, officials at the National Institutes of Health plan to establish by next year a single public registry for information on genetic tests. There are currently more than 1,600 genetics tests available but there is no single public way to search for information about their availability, validity, and usefulness, according to the NIH. “The need for this database reflects how far we have come in the last 10 years,” NIH director Dr. Francis S. Collins commented in a statement. “The registry will help consumers and health care providers determine the best options for genetic testing, which is becoming more and more common and accessible.” More information on the registry is available online at

www.ncbi.nlm.nih.gov/gtr/

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the “doughnut hole,” when they must pay 100% of prescription costs until the totals they and the plans pay reach $6,154, according to a report prepared by the Government Accountability Office. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole, or catastrophic threshold, beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, those used to treat cancer, and antiviral drugs. Medicare supplement-plan sponsors told the GAO that they had little leverage to negotiate price concessions for most of the specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years and states have cut a total of nearly $392 million in public health programs in the past year, according to a report from the Robert Wood Johnson Foundation and the Trust for America's Health. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person and considerably less than the $19.80 per person that states in the northeast received. Western states received $19.22 per person, whereas southern states got $19.75 per person.

Food Poisoning Cost Is Sickening

Each case of foodborne illness, such as from Escherichia coli and Campylobacter, costs an average of $1,850 in treatment and other health costs, totaling $152 billion for the nation annually, according to findings in a study by the Pew Charitable Trusts at Georgetown University in Washington. Cases related to tainted produce cost $39 billion in just medical costs per year. “Although this study only addresses the health-related costs of foodborne illness, the total cost of foodborne illness also includes costs to industry and government from outbreaks,” according to the report. Totals vary significantly among the states. The 10 states with the highest costs per case were Hawaii, Florida, Connecticut, Pennsylvania, South Carolina, the District of Columbia, Mississippi, New York, Massachusetts, and New Jersey. According to the Centers for Disease Control and Prevention, there are 76 million new cases of food-related illness that result in 5,000 deaths and 325,000 hospitalizations in the United States each year.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, released in March, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011. The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. It also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Both programs would be voluntary.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, released in March, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011. The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. It also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Both programs would be voluntary.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for the use of health information technology.

The proposed rule, released in March, establishes a temporary certification program in which the National Coordinator for Health Information Technology, Dr. David Blumenthal, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules.

Under the temporary program, Dr. Blumenthal's office would take on many of the functions, such as accreditation, that will later be performed by private groups. The idea is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011. The rule also proposes the creation of a permanent certification program that would eventually replace the temporary one. The permanent program would be more sophisticated, dividing the responsibility for testing and certification among different organizations. It also would include accreditation processes and set forth the requirement that certification bodies perform surveillance of certified EHR products. Both programs would be voluntary.

Colchicine Discounts Expanded

URL Pharma Inc. has expanded its patient assistance program for gout and familial Mediterranean fever patients taking Colcrys (colchicine). Uninsured and Medicare Part D patients with household incomes up to six times the federal poverty level will be eligible to receive the drug at a discount. For example, patients with household incomes up to $88,000 per year for a family of four may receive Colcrys for $5 per month. Patients can sign up for the program at

www.needymeds.org

www.colcrys.com

RA Drug's Future Looks Lucrative

AstraZeneca is making a down payment of $100 million for the right to commercialize some uses of Rigel Pharmaceuticals Inc.'s R788 (fostamatinib disodium), which has completed phase II trials in patients with rheumatoid arthritis. The drug is an oral spleen tyrosine kinase (SyK) inhibitor. Under the deal, AstraZeneca will have exclusive rights to any indications of fostamatinib disodium besides rheumatoid arthritis, as well as to Rigel's portfolio of oral SyK inhibitors. AstraZeneca will design a phase III program for fostamatinib disodium with the goal of filing new drug applications with both the Food and Drug Administration and the European Medicines Agency sometime in 2013. If the drug meets specified development, regulatory, and early-sales targets, AstraZeneca could pay another $345 million to Rigel. And if the drug becomes a commercial success, Rigel could receive another $800 million plus royalties. “There is a very real and pressing unmet need in the area of rheumatoid arthritis,” Anders Ekblom, executive vice president of development for AstraZeneca, said in a statement. “AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound.”

Government Workers Covered

Two-thirds of the nation's nearly 20 million state and local government workers got their health insurance through their employers in 2008, a much higher percentage than among private sector workers, according to the Agency for Healthcare Research and Quality. Premiums for one-person plans ranged from $4,560 to $6,631; family plan premiums cost between $12,068 and $16,965 per year. New England government workers had the highest average premiums, and insured singles in that region were subject to the most cost sharing in the country. The family plans of workers in Arkansas, Louisiana, Oklahoma, and Texas were subject to the highest cost sharing. Workers in New Jersey, New York, and Pennsylvania contributed the least to their premiums for both one-person and family coverage, the report said.

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the doughnut hole, when they must pay 100% of prescription costs until the totals that they and the plans pay reach $6,154, according to a Government Accountability Office report. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole (the catastrophic threshold), beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, drugs used to treat cancer, and antiviral drugs. Medicare supplement–plan sponsors told the GAO that they had little leverage to negotiate price concessions for most specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years, and states have cut a total of nearly $392 million in public health programs in the past year, a report from the Robert Wood Johnson Foundation and the Trust for America's Health shows. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person, which is considerably less than the $19.80 per person that states in the Northeast received. Western states received $19.22 per person, whereas Southern states got $19.75 per person.

FDA Warns on Food Labels

The FDA has notified 17 food manufacturers, including Gorton's Inc. and Nestlé, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy,” the FDA said. Nestl, for example, was warned about using “100% juice” to describe a product that had added flavors. The FDA told Gorton's that its fish fillet packages must disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.

Colchicine Discounts Expanded

URL Pharma Inc. has expanded its patient assistance program for gout and familial Mediterranean fever patients taking Colcrys (colchicine). Uninsured and Medicare Part D patients with household incomes up to six times the federal poverty level will be eligible to receive the drug at a discount. For example, patients with household incomes up to $88,000 per year for a family of four may receive Colcrys for $5 per month. Patients can sign up for the program at

www.needymeds.org

www.colcrys.com

RA Drug's Future Looks Lucrative

AstraZeneca is making a down payment of $100 million for the right to commercialize some uses of Rigel Pharmaceuticals Inc.'s R788 (fostamatinib disodium), which has completed phase II trials in patients with rheumatoid arthritis. The drug is an oral spleen tyrosine kinase (SyK) inhibitor. Under the deal, AstraZeneca will have exclusive rights to any indications of fostamatinib disodium besides rheumatoid arthritis, as well as to Rigel's portfolio of oral SyK inhibitors. AstraZeneca will design a phase III program for fostamatinib disodium with the goal of filing new drug applications with both the Food and Drug Administration and the European Medicines Agency sometime in 2013. If the drug meets specified development, regulatory, and early-sales targets, AstraZeneca could pay another $345 million to Rigel. And if the drug becomes a commercial success, Rigel could receive another $800 million plus royalties. “There is a very real and pressing unmet need in the area of rheumatoid arthritis,” Anders Ekblom, executive vice president of development for AstraZeneca, said in a statement. “AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound.”

Government Workers Covered

Two-thirds of the nation's nearly 20 million state and local government workers got their health insurance through their employers in 2008, a much higher percentage than among private sector workers, according to the Agency for Healthcare Research and Quality. Premiums for one-person plans ranged from $4,560 to $6,631; family plan premiums cost between $12,068 and $16,965 per year. New England government workers had the highest average premiums, and insured singles in that region were subject to the most cost sharing in the country. The family plans of workers in Arkansas, Louisiana, Oklahoma, and Texas were subject to the highest cost sharing. Workers in New Jersey, New York, and Pennsylvania contributed the least to their premiums for both one-person and family coverage, the report said.

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the doughnut hole, when they must pay 100% of prescription costs until the totals that they and the plans pay reach $6,154, according to a Government Accountability Office report. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole (the catastrophic threshold), beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, drugs used to treat cancer, and antiviral drugs. Medicare supplement–plan sponsors told the GAO that they had little leverage to negotiate price concessions for most specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years, and states have cut a total of nearly $392 million in public health programs in the past year, a report from the Robert Wood Johnson Foundation and the Trust for America's Health shows. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person, which is considerably less than the $19.80 per person that states in the Northeast received. Western states received $19.22 per person, whereas Southern states got $19.75 per person.

FDA Warns on Food Labels

The FDA has notified 17 food manufacturers, including Gorton's Inc. and Nestlé, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy,” the FDA said. Nestl, for example, was warned about using “100% juice” to describe a product that had added flavors. The FDA told Gorton's that its fish fillet packages must disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.

Colchicine Discounts Expanded

URL Pharma Inc. has expanded its patient assistance program for gout and familial Mediterranean fever patients taking Colcrys (colchicine). Uninsured and Medicare Part D patients with household incomes up to six times the federal poverty level will be eligible to receive the drug at a discount. For example, patients with household incomes up to $88,000 per year for a family of four may receive Colcrys for $5 per month. Patients can sign up for the program at

www.needymeds.org

www.colcrys.com

RA Drug's Future Looks Lucrative

AstraZeneca is making a down payment of $100 million for the right to commercialize some uses of Rigel Pharmaceuticals Inc.'s R788 (fostamatinib disodium), which has completed phase II trials in patients with rheumatoid arthritis. The drug is an oral spleen tyrosine kinase (SyK) inhibitor. Under the deal, AstraZeneca will have exclusive rights to any indications of fostamatinib disodium besides rheumatoid arthritis, as well as to Rigel's portfolio of oral SyK inhibitors. AstraZeneca will design a phase III program for fostamatinib disodium with the goal of filing new drug applications with both the Food and Drug Administration and the European Medicines Agency sometime in 2013. If the drug meets specified development, regulatory, and early-sales targets, AstraZeneca could pay another $345 million to Rigel. And if the drug becomes a commercial success, Rigel could receive another $800 million plus royalties. “There is a very real and pressing unmet need in the area of rheumatoid arthritis,” Anders Ekblom, executive vice president of development for AstraZeneca, said in a statement. “AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound.”

Government Workers Covered

Two-thirds of the nation's nearly 20 million state and local government workers got their health insurance through their employers in 2008, a much higher percentage than among private sector workers, according to the Agency for Healthcare Research and Quality. Premiums for one-person plans ranged from $4,560 to $6,631; family plan premiums cost between $12,068 and $16,965 per year. New England government workers had the highest average premiums, and insured singles in that region were subject to the most cost sharing in the country. The family plans of workers in Arkansas, Louisiana, Oklahoma, and Texas were subject to the highest cost sharing. Workers in New Jersey, New York, and Pennsylvania contributed the least to their premiums for both one-person and family coverage, the report said.

Seniors Hit by Drug Expenses

Medicare Part D enrollees who used high-cost, “specialty tier” drugs are much more likely than other beneficiaries to reach the doughnut hole, when they must pay 100% of prescription costs until the totals that they and the plans pay reach $6,154, according to a Government Accountability Office report. More than half of Medicare beneficiaries with drug coverage who took one or more of the high-cost drugs spent at least $4,645 out of their own pockets in 2007 and reached the high end of the doughnut hole (the catastrophic threshold), beyond which the government pays at least 80% of all drug costs. Meanwhile, only 8% of beneficiaries who did not use specialty tier–eligible drugs reached the catastrophic threshold. Specialty tier drugs include immunosuppressant drugs, drugs used to treat cancer, and antiviral drugs. Medicare supplement–plan sponsors told the GAO that they had little leverage to negotiate price concessions for most specialty tier–eligible drugs.

Public Health Funding Is Down

Federal funding for public health has remained flat for nearly 5 years, and states have cut a total of nearly $392 million in public health programs in the past year, a report from the Robert Wood Johnson Foundation and the Trust for America's Health shows. That has left communities around the country struggling to deliver basic disease prevention and emergency health preparedness services, the report said. “Chronic underfunding for public health means that millions of Americans are needlessly suffering from preventable diseases, health care costs have skyrocketed, and our workforce is not as healthy as it needs to be to compete with the rest of the world,” said Jeffrey Levi, Ph.D., who is the trust's executive director. States in the Midwest received the least funding for disease prevention in public health in fiscal year 2009—a total of $16.50 per person, which is considerably less than the $19.80 per person that states in the Northeast received. Western states received $19.22 per person, whereas Southern states got $19.75 per person.

FDA Warns on Food Labels

The FDA has notified 17 food manufacturers, including Gorton's Inc. and Nestlé, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy,” the FDA said. Nestl, for example, was warned about using “100% juice” to describe a product that had added flavors. The FDA told Gorton's that its fish fillet packages must disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for using health information technology.

The proposed rule establishes a temporary certification program in which Dr. David Blumenthal, National Coordinator for Health Information Technology, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules. Dr. Blumenthal's office would take on many of the functions (such as accreditation) that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent, more sophisticated certification program that would eventually replace the temporary one. It would divide the responsibility for testing and certification among different organizations, and would set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available,” he said in a statement.

Earlier, the government issued a proposed rule outlining criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for product certification.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for using health information technology.

The proposed rule establishes a temporary certification program in which Dr. David Blumenthal, National Coordinator for Health Information Technology, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules. Dr. Blumenthal's office would take on many of the functions (such as accreditation) that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent, more sophisticated certification program that would eventually replace the temporary one. It would divide the responsibility for testing and certification among different organizations, and would set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available,” he said in a statement.

Earlier, the government issued a proposed rule outlining criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for product certification.

The federal government has put forward its plan to test and certify electronic health records in preparation for the Medicare and Medicaid incentive program that will reward physicians for using health information technology.

The proposed rule establishes a temporary certification program in which Dr. David Blumenthal, National Coordinator for Health Information Technology, will designate certain organizations to test and certify complete electronic health records (EHRs) and related modules. Dr. Blumenthal's office would take on many of the functions (such as accreditation) that will later be performed by private groups. The idea behind the temporary program is to ensure that certified EHR products are available before the first incentives for use of certified systems begin in 2011.

The rule also proposes the creation of a permanent, more sophisticated certification program that would eventually replace the temporary one. It would divide the responsibility for testing and certification among different organizations, and would set forth the requirement that certification bodies perform surveillance of certified EHR products. Certification bodies also may be able to assess additional health information technology products beyond EHRs and their modules. Both certification programs would be voluntary.

Dr. Blumenthal called publication of the proposed rule an “important first step” to bringing structure to the evaluation of EHRs and EHR modules. “The programs will help support end users of certified products, and ultimately serve the interests of each patient by ensuring that their information is securely managed and available,” he said in a statement.

Earlier, the government issued a proposed rule outlining criteria for meaningful use of EHRs and an interim final rule that included an initial set of standards and specifications for product certification.

Top scientists at the National Institutes of Health and the Food and Drug Administration will be working together more closely in an effort to improve regulatory science and bring new treatments to market sooner.

With more new treatments based on emerging technologies, NIH and FDA scientists must communicate earlier and more often, explained Kathleen Sebelius, secretary of the Department of Health and Human Services. From the beginning of a therapy's development, basic scientists at the NIH should share information with the FDA so that FDA regulators can develop appropriate safety and effectiveness standards early on.

At the same time, FDA scientists can help researchers identify possible safety or quality issues earlier in the process, she said during a news conference to announce the partnership.

“By communicating throughout the process, it will help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment's risks and benefits,” Ms. Sebelius said. “For Americans, this is going to mean that new treatments are available sooner.”

The initiative calls for the creation of a joint FDA–NIH Leadership Council that will include FDA Commissioner Dr. Margaret A. Hamburg and NIH Director Dr. Francis S. Collins, as well as six senior scientists from each of the two agencies. The NIH and the FDA have also pooled their resources to offer $6.75 million in grants over the next 3 years for research on regulatory science. For example, the agencies are looking for ideas on how the FDA would evaluate safety and effectiveness in new stem cell therapies.

Government officials will be seeking public comment on how the two agencies can improve their collaboration. The NIH and the FDA will hold a public meeting jointly this spring to gather input from industry, patient advocates, and the public.

To bring safe, effective therapies into the market sooner, the science used to develop new therapeutic compounds must be closely connected to the science the FDA uses to review those compounds, said Dr. Collins of the NIH.

Top scientists at the National Institutes of Health and the Food and Drug Administration will be working together more closely in an effort to improve regulatory science and bring new treatments to market sooner.

With more new treatments based on emerging technologies, NIH and FDA scientists must communicate earlier and more often, explained Kathleen Sebelius, secretary of the Department of Health and Human Services. From the beginning of a therapy's development, basic scientists at the NIH should share information with the FDA so that FDA regulators can develop appropriate safety and effectiveness standards early on.

At the same time, FDA scientists can help researchers identify possible safety or quality issues earlier in the process, she said during a news conference to announce the partnership.

“By communicating throughout the process, it will help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment's risks and benefits,” Ms. Sebelius said. “For Americans, this is going to mean that new treatments are available sooner.”

The initiative calls for the creation of a joint FDA–NIH Leadership Council that will include FDA Commissioner Dr. Margaret A. Hamburg and NIH Director Dr. Francis S. Collins, as well as six senior scientists from each of the two agencies. The NIH and the FDA have also pooled their resources to offer $6.75 million in grants over the next 3 years for research on regulatory science. For example, the agencies are looking for ideas on how the FDA would evaluate safety and effectiveness in new stem cell therapies.

Government officials will be seeking public comment on how the two agencies can improve their collaboration. The NIH and the FDA will hold a public meeting jointly this spring to gather input from industry, patient advocates, and the public.

To bring safe, effective therapies into the market sooner, the science used to develop new therapeutic compounds must be closely connected to the science the FDA uses to review those compounds, said Dr. Collins of the NIH.

Top scientists at the National Institutes of Health and the Food and Drug Administration will be working together more closely in an effort to improve regulatory science and bring new treatments to market sooner.

With more new treatments based on emerging technologies, NIH and FDA scientists must communicate earlier and more often, explained Kathleen Sebelius, secretary of the Department of Health and Human Services. From the beginning of a therapy's development, basic scientists at the NIH should share information with the FDA so that FDA regulators can develop appropriate safety and effectiveness standards early on.

At the same time, FDA scientists can help researchers identify possible safety or quality issues earlier in the process, she said during a news conference to announce the partnership.

“By communicating throughout the process, it will help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment's risks and benefits,” Ms. Sebelius said. “For Americans, this is going to mean that new treatments are available sooner.”

The initiative calls for the creation of a joint FDA–NIH Leadership Council that will include FDA Commissioner Dr. Margaret A. Hamburg and NIH Director Dr. Francis S. Collins, as well as six senior scientists from each of the two agencies. The NIH and the FDA have also pooled their resources to offer $6.75 million in grants over the next 3 years for research on regulatory science. For example, the agencies are looking for ideas on how the FDA would evaluate safety and effectiveness in new stem cell therapies.

Government officials will be seeking public comment on how the two agencies can improve their collaboration. The NIH and the FDA will hold a public meeting jointly this spring to gather input from industry, patient advocates, and the public.

To bring safe, effective therapies into the market sooner, the science used to develop new therapeutic compounds must be closely connected to the science the FDA uses to review those compounds, said Dr. Collins of the NIH.